Medication Guides
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Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events (side effects). This database does not include Medication Guides for FDA-approved allergenic or cellular/tissue products (see FDA Online Label Repository or DailyMed for these Medication Guides). More
Click on drug name to view Medication Guide in PDF format.
| Drug Name | Active Ingredient | Form;Route | Appl. No. | Company | Date | Link |
|---|---|---|---|---|---|---|
| Drug Name | Active Ingredient | Form;Route | Appl. No. | Company | Date | Link |
| Abilify | Aripiprazole | TABLET;ORAL | 021436 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
| Abilify | Aripiprazole | SOLUTION;ORAL | 021713 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
| Abilify | Aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf#page=84 |
| Abilify | Aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
| Abilify | Aripiprazole | INJECTABLE;INTRAMUSCULAR | 021866 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf#page=84 |
| Abilify | Aripiprazole | INJECTABLE;INTRAMUSCULAR | 021866 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
| Abilify Maintena Kit | Aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971 | OTSUKA PHARM CO LTD | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf#page=52 |
| Abilify Mycite Kit | Aripiprazole | TABLET;ORAL | 207202 | OTSUKA | 12/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf#page=48 |
| Abilify Mycite Kit | Aripiprazole | TABLET;ORAL | 207202 | OTSUKA | 12/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf#page=44 |
| Abrilada | Adalimumab-Afzb | INJECTABLE;INJECTION | 761118 | PFIZER INC | 11/15/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761118s000lbl.pdf#page=39 |
| Absorica | Isotretinoin | CAPSULE;ORAL | 021951 | SUN PHARM INDS INC | 12/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf#page=32 |
| Abstral | Fentanyl Citrate | TABLET;SUBLINGUAL | 022510 | SENTYNL THERAPS INC | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf#page=29 |
| Accutane | Isotretinoin | CAPSULE;ORAL | 018662 | HOFFMANN LA ROCHE | 10/22/2010 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedGuide.pdf |
| Aciphex | Rabeprazole Sodium | TABLET, DELAYED RELEASE;ORAL | 020973 | EISAI INC | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020973s041lbl.pdf#page=34 |
| Aciphex Sprinkle | Rabeprazole Sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736 | AYTU | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf#page=21 |
| Actemra | Tocilizumab | INJECTABLE; INJECTION | 125276 | GENENTECH | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf#page=46 |
| Actemra | Tocilizumab | INJECTABLE; INJECTION | 125276 | GENENTECH | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125276s131lbl.pdf#page=49 |
| Actemra | Tocilizumab | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 125472 | GENENTECH | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf#page=46 |
| Actemra | Tocilizumab | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 125472 | GENENTECH | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf#page=49 |
| Actiq | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747 | CEPHALON | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020747s053lbl.pdf#page=43 |
| Actonel | Risedronate Sodium | TABLET;ORAL | 020835 | APIL | 11/05/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf#page=38 |
| Actonel | Risedronate Sodium | TABLET;ORAL | 020835 | APIL | 11/05/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020835s052lbl.pdf#page=38 |
| Actonel With Calcium (Copackaged) | Calcium Carbonate; Risedronate Sodium | TABLET, TABLET;ORAL | 021823 | WARNER CHILCOTT | 04/08/2015 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf#page=27 |
| Actoplus MET | Metformin Hydrochloride; Pioglitazone Hydrochloride | TABLET;ORAL | 021842 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf#page=41 |
| Actoplus MET XR | Metformin Hydrochloride; Pioglitazone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf#page=41 |
| Actos | Pioglitazone Hydrochloride | TABLET;ORAL | 021073 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35 |
| Adasuve | Loxapine | POWDER;INHALATION | 022549 | ALEXZA PHARMS | 02/23/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf#page=26 |
| Adderall 10 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall 12.5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall 15 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall 20 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall 30 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall 5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall 7.5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf |
| Adderall XR 10 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
| Adderall XR 15 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
| Adderall XR 20 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
| Adderall XR 25 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
| Adderall XR 30 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
| Adderall XR 5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
| Addyi | Flibanserin | TABLET;ORAL | 022526 | SPROUT PHARMS | 10/09/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf#page=23 |
| Adempas | Riociguat | TABLET;ORAL | 204819 | BAYER HLTHCARE | 11/30/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf#page=24 |
| Adhansia XR | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212038 | PURDUE PHARMA LP | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf#page=24 |
| Adlyxin | Lixisenatide | SOLUTION;SUBCUTANEOUS | 208471 | SANOFI-AVENTIS US | 07/27/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf#page=31 |
| Adzenys ER | Amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325 | NEOS THERAPS INC | 09/15/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf#page=26 |
| Ambien | Zolpidem Tartrate | TABLET;ORAL | 019908 | SANOFI AVENTIS US | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf#page=23 |
| Ambien CR | Zolpidem Tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774 | SANOFI AVENTIS US | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf#page=26 |
| Amjevita | Adalimumab-Atto | INJECTABLE;INJECTION | 761024 | AMGEN INC | 06/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf#page=39 |
| Ampyra | Dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250 | ACORDA | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s018lbl.pdf#page=13 |
| Anafranil | Clomipramine Hydrochloride | CAPSULE;ORAL | 019906 | SPECGX LLC | 05/10/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019906s043lbl.pdf#page=27 |
| Anaprox | Naproxen Sodium | TABLET;ORAL | 018164 | ATNAHS PHARMA US | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22 |
| Anaprox DS | Naproxen Sodium | TABLET;ORAL | 018164 | ATNAHS PHARMA US | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22 |
| Androgel | Testosterone | GEL, METERED;TRANSDERMAL | 021015 | ABBVIE | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf#page=23 |
| Androgel | Testosterone | GEL;TRANSDERMAL | 021015 | ABBVIE | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf#page=23 |
| Androgel | Testosterone | GEL, METERED;TRANSDERMAL | 022309 | ABBVIE | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf#page=25 |
| Androgel | Testosterone | GEL;TRANSDERMAL | 022309 | ABBVIE | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf#page=25 |
| Ansaid | Flurbiprofen | TABLET;ORAL | 018766 | PHARMACIA AND UPJOHN | 05/09/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf |
| Apadaz | Acetaminophen; Benzhydrocodone Hydrochloride | TABLET;ORAL | 208653 | KVK TECH INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208653s007lbl.pdf#page=38 |
| Aplenzin | Bupropion Hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108 | BAUSCH | 05/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf#page=28 |
| Aplenzin | Bupropion Hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108 | BAUSCH | 05/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022108s020lbl.pdf#page=28 |
| Aptensio XR | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831 | RHODES PHARMS | 06/14/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205831s005lbl.pdf#page=22 |
| Aptiom | Eslicarbazepine Acetate | TABLET;ORAL | 022416 | SUNOVION PHARMS INC | 03/15/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022416s011lbl.pdf#page=25 |
| Aranesp | Darbepoetin Alfa | VIAL; INTRAVENOUS | 103951 | AMGEN | 01/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25 |
| Aranesp | Darbepoetin Alfa | VIAL; SUBCUTANEOUS | 103951 | AMGEN | 01/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25 |
| Arcapta Neohaler | Indacaterol Maleate | POWDER;INHALATION | 022383 | NOVARTIS | 05/29/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf |
| Arikayce Kit | Amikacin Sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356 | INSMED INC | 10/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf#page=15 |
| Aristada | Aripiprazole LAuroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533 | ALKERMES INC | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf#page=35 |
| Aristada | Aripiprazole LAuroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533 | ALKERMES INC | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=36 |
| Aristada Initio Kit | Aripiprazole LAuroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830 | ALKERMES INC | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=72 |
| Arthrotec | Diclofenac Sodium; Misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607 | PFIZER | 09/24/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085919.pdf |
| Arthrotec | Diclofenac Sodium; Misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607 | PFIZER | 09/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s033lbl.pdf#page=31 |
| Arthrotec | Diclofenac Sodium; Misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607 | PFIZER | 09/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020607s036lbl.pdf#page=31 |
| Arymo ER | Morphine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 208603 | ZYLA | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf#page=34 |
| Arzerra | Ofatumumab | INJECTABLE; INJECTION | 125326 | NOVARTIS | 08/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf#page=13 |
| Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096 | ASTELLAS | 12/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204096s009lbl.pdf#page=31 |
| Atelvia | Risedronate Sodium | TABLET, DELAYED RELEASE;ORAL | 022560 | APIL | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022560s011lbl.pdf#page=24 |
| Ativan | Lorazepam | TABLET;ORAL | 017794 | BAUSCH | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017794s048lbl.pdf#page=13 |
| Aubagio | Teriflunomide | TABLET;ORAL | 202992 | SANOFI AVENTIS US | 11/06/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf#page=25 |
| Austedo | Deutetrabenazine | TABLET;ORAL | 208082 | TEVA BRANDED PHARM | 02/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208082s004lbl.pdf#page=25 |
| Austedo | Deutetrabenazine | TABLET;ORAL | 208082 | TEVA BRANDED PHARM | 02/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208082s007lbl.pdf#page=25 |
| Avandamet | Metformin Hydrochloride; Rosiglitazone Maleate | TABLET;ORAL | 021410 | SB PHARMCO | 04/05/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf#page=38 |
| Avandaryl | Glimepiride; Rosiglitazone Maleate | TABLET;ORAL | 021700 | SB PHARMCO | 12/16/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf#page=39 |
| Avandia | Rosiglitazone Maleate | TABLET;ORAL | 021071 | SB PHARMCO | 02/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf#page=38 |
| Aveed | Testosterone Undecanoate | INJECTABLE;INTRAMUSCULAR | 022219 | ENDO PHARMS INC | 06/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf#page=23 |
| Avelox | Moxifloxacin Hydrochloride | TABLET;ORAL | 021085 | BAYER HLTHCARE | 05/06/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33 |
| Avelox in Sodium Chloride 0.8% in Plastic Container | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 021277 | BAYER HLTHCARE | 05/06/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021085s065,021277s061lbl.pdf#page=33 |
| Avelox in Sodium Chloride 0.8% in Plastic Container | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 021277 | BAYER HLTHCARE | 05/06/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33 |
| Avinza | Morphine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021260 | KING PHARMS LLC | 06/26/2015 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311346.pdf |
| Avonex | Interferon Beta-1a | VIAL | 103628 | BIOGEN | 03/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103628s5264lbl.pdf#page=21 |
| Avsola | Infliximab-Axxq | INJECTABLE;INJECTION | 761086 | AMGEN INC | 12/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761086s000lbl.pdf#page=48 |
| Axiron | Testosterone | SOLUTION, METERED;TRANSDERMAL | 022504 | ELI LILLY AND CO | 07/13/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf#page=15 |
| Azstarys | Serdexmethylphenidate Chloride; Dexmethylphenidate Hydrochloride | CAPSULE;ORAL | 212994 | COMMCAVE THERAPEUTICS SA | 03/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212994s000lbl.pdf#page=26 |
| Banzel | Rufinamide | TABLET;ORAL | 021911 | EISAI INC | 11/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19 |
| Banzel | Rufinamide | SUSPENSION;ORAL | 201367 | EISAI INC | 11/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19 |
| Bavencio | Avelumab | INJECTABLE;INJECTION | 761049 | EMD SERONO INC | 11/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf#page=36 |
| Bavencio | Avelumab | INJECTABLE;INJECTION | 761049 | EMD SERONO INC | 11/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf#page=36 |
| Bavencio | Avelumab | INJECTABLE;INTRAVENOUS | 761078 | EMD SERONO INC | 05/09/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf#page=23 |
| Baxdela | Delafloxacin Meglumine | TABLET;ORAL | 208610 | MELINTA | 10/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf#page=23 |
| Baxdela | Delafloxacin Meglumine | TABLET;ORAL | 208610 | MELINTA | 10/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28 |
| Baxdela | Delafloxacin Meglumine | POWDER;INTRAVENOUS | 208611 | MELINTA | 10/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf#page=23 |
| Baxdela | Delafloxacin Meglumine | POWDER;INTRAVENOUS | 208611 | MELINTA | 10/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28 |
| Belbuca | Buprenorphine Hydrochloride | FILM;BUCCAL | 207932 | BDSI | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207932s015lbl.pdf#page=37 |
| Belsomra | Suvorexant | TABLET;ORAL | 204569 | MERCK SHARP DOHME | 03/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf#page=22 |
| Belsomra | Suvorexant | TABLET;ORAL | 204569 | MERCK SHARP DOHME | 03/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf#page=23 |
| Belsomra | Suvorexant | TABLET;ORAL | 204569 | MERCK SHARP DOHME | 03/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf#page23 |
| Belsomra | Suvorexant | TABLET;ORAL | 204569 | MERCK SHARP DOHME | 03/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf#page=23 |
| Benlysta | Belimumab | INJECTABLE; INJECTION | 125370 | HUMAN GENOME SCIENCES INC. | 12/16/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf#page=42 |
| Benlysta | Belimumab | INJECTABLE; INJECTION | 125370 | HUMAN GENOME SCIENCES INC. | 12/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf#page=33 |
| Benlysta | Belimumab | INJECTABLE;INJECTION | 761043 | GLAXOSMITHKLINE LLC | 12/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf#page=33 |
| Benlysta | Belimumab | INJECTABLE;INJECTION | 761043 | GLAXOSMITHKLINE LLC | 12/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf#page=42 |
| Betaseron | Interferon Beta-1b | VIAL; SUBCUTANEOUS | 103471 | BAYER HEALTHCARE PHARMS | 11/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf#page=18 |
| Bevyxxa | Betrixaban | CAPSULE;ORAL | 208383 | PORTOLA PHARMS INC | 08/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20 |
| Binosto | Alendronate Sodium | TABLET, EFFERVESCENT;ORAL | 202344 | ASCEND THERAPS US | 10/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf#page=33 |
| Blenrep | Belantamab Mafodotin-Blmf | INJECTABLE;INTRAVENOUS | 761158 | GLAXOSMITHKLINE | 11/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf#page=21 |
| Blincyto | Blinatumomab | INJECTABLE;INJECTION | 125557 | AMGEN | 03/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf#page=33 |
| Boniva | Ibandronate Sodium | TABLET;ORAL | 021455 | HOFFMANN LA ROCHE | 12/07/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf#page=19 |
| Boniva | Ibandronate Sodium | INJECTABLE;INTRAVENOUS | 021858 | ROCHE | 12/07/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18 |
| Bonsity | Teriparatide | SOLUTION;SUBCUTANEOUS | 211939 | ALVOGEN | 10/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211939s000lbl.pdf#page=25 |
| Botox | Onabotulinumtoxina | VIAL; SINGLE-USE | 103000 | ALLERGAN | 02/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5318lbl.pdf#page=50 |
| Botox Cosmetic | Onabotulinumtoxina | VIAL; SINGLE-USE | 103000 | ALLERGAN | 02/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5318lbl.pdf#page=50 |
| Braftovi | Encorafenib | CAPSULE;ORAL | 210496 | ARRAY BIOPHARMA INC | 04/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210496s003lbl.pdf#page=18 |
| Brilinta | Ticagrelor | TABLET;ORAL | 022433 | ASTRAZENECA | 02/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022433s031lbl.pdf#page=34 |
| Brisdelle | Paroxetine Mesylate | CAPSULE;ORAL | 204516 | SEBELA IRELAND LTD | 04/28/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf#page=22 |
| Briviact | Brivaracetam | TABLET;ORAL | 205836 | UCB INC | 05/10/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17 |
| Briviact | Brivaracetam | SOLUTION;INTRAVENOUS | 205837 | UCB INC | 05/10/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17 |
| Briviact | Brivaracetam | SOLUTION;ORAL | 205838 | UCB INC | 05/10/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17 |
| Brovana | Arformoterol Tartrate | SOLUTION;INHALATION | 021912 | SUNOVION | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf#page=22 |
| Bunavail | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;BUCCAL | 205637 | BDSI | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205637s021lbl.pdf#page=33 |
| Butrans | Buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | PURDUE PHARMA LP | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021306s037lbl.pdf#page=43 |
| Bydureon | Exenatide Synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | ASTRAZENECA AB | 02/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf#page=31 |
| Bydureon Bcise | Exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210 | ASTRAZENECA AB | 12/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf#page=32 |
| Bydureon Bcise | Exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210 | ASTRAZENECA AB | 12/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s011lbl.pdf#page=33 |
| Bydureon Bcise | Exenatide | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210 | ASTRAZENECA AB | 12/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s014lbl.pdf#page=33 |
| Bydureon Pen | Exenatide Synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | ASTRAZENECA AB | 02/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf#page=31 |
| Byetta | Exenatide Synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | ASTRAZENECA AB | 02/28/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf |
| Byetta | Exenatide Synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | ASTRAZENECA AB | 02/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021773s041lbl.pdf#page=32 |
| Byetta | Exenatide Synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | ASTRAZENECA AB | 02/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf#page=35 |
| Byetta | Exenatide Synthetic | INJECTABLE; SUBCUTANEOUS | 021919 | AMYLIN | 10/30/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf |
| Cambia | Diclofenac Potassium | FOR SOLUTION;ORAL | 022165 | ASSERTIO | 03/20/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM169077.pdf |
| Cambia | Diclofenac Potassium | FOR SOLUTION;ORAL | 022165 | ASSERTIO | 03/20/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf#page=19 |
| Campath | Alemtuzumab | VIAL; INTRAVENOUS | 103948 | GENZYME | 03/12/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf#page=30 |
| Caprelsa | Vandetanib | TABLET;ORAL | 022405 | GENZYME CORP | 06/15/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s017lbl.pdf#page=20 |
| Carbatrol | Carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | TAKEDA PHARMS USA | 08/26/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf |
| Cassipa | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;SUBLINGUAL | 208042 | TEVA PHARMS USA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208042s004lbl.pdf#page=30 |
| Cataflam | Diclofenac Potassium | TABLET;ORAL | 020142 | NOVARTIS | 05/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135935.pdf |
| Celebrex | Celecoxib | CAPSULE;ORAL | 020998 | GD SEARLE | 05/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020998s054lbl.pdf#page=21 |
| Celebrex | Celecoxib | CAPSULE;ORAL | 021156 | GD SEARLE LLC | 02/04/2011 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003MedG.pdf |
| Celexa | Citalopram Hydrobromide | TABLET;ORAL | 020822 | ALLERGAN | 01/11/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf#page=33 |
| Celexa | Citalopram Hydrobromide | SOLUTION;ORAL | 021046 | FOREST LABS | 12/03/2012 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088568.pdf |
| Cellcept | Mycophenolate Mofetil | CAPSULE;ORAL | 050722 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39 |
| Cellcept | Mycophenolate Mofetil | CAPSULE;ORAL | 050722 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38 |
| Cellcept | Mycophenolate Mofetil | TABLET;ORAL | 050723 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39 |
| Cellcept | Mycophenolate Mofetil | TABLET;ORAL | 050723 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38 |
| Cellcept | Mycophenolate Mofetil Hydrochloride | INJECTABLE;INJECTION | 050758 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39 |
| Cellcept | Mycophenolate Mofetil Hydrochloride | INJECTABLE;INJECTION | 050758 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38 |
| Cellcept | Mycophenolate Mofetil | SUSPENSION;ORAL | 050759 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39 |
| Cellcept | Mycophenolate Mofetil | SUSPENSION;ORAL | 050759 | ROCHE PALO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38 |
| Celontin | Methsuximide | CAPSULE;ORAL | 010596 | PARKE DAVIS | 06/15/2011 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf |
| Cerdelga | Eliglustat Tartrate | CAPSULE;ORAL | 205494 | GENZYME CORP | 08/29/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494Orig1s000lbl.pdf |
| Cerdelga | Eliglustat Tartrate | CAPSULE;ORAL | 205494 | GENZYME CORP | 08/29/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf#page=19 |
| Chantix | Varenicline Tartrate | TABLET;ORAL | 021928 | PF PRISM CV | 02/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22 |
| Children's Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride | SYRUP;ORAL | 212266 | QUAGEN | 05/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf#page=14 |
| Chlordiazepoxide and Amitriptyline Hydrochloride | Amitriptyline Hydrochloride; Chlordiazepoxide | TABLET;ORAL | 071297 | MYLAN PHARMS INC | 02/05/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf |
| Cimzia | Certolizumab Pegol | INJECTABLE; INJECTION | 125160 | UCB INC | 09/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf#page=37 |
| Cimzia | Certolizumab Pegol | INJECTABLE; INJECTION | 125160 | UCB INC | 09/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s237lbl.pdf#page=40 |
| Cimzia | Certolizumab Pegol | INJECTABLE; INJECTION | 125160 | UCB INC | 09/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf#page=39 |
| Cimzia | Certolizumab Pegol | INJECTABLE; INJECTION | 125160 | UCB INC | 09/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s293lbl.pdf#page=41 |
| Cipro | Ciprofloxacin Hydrochloride | TABLET;ORAL | 019537 | BAYER HLTHCARE | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s093,020780s049lbl.pdf#page=40 |
| Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 05/08/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf |
| Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019847s059lbl.pdf#page=32 |
| Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019847s060lbl.pdf#page=32 |
| Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s061lbl.pdf#page=33 |
| Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s062lbl.pdf#page=33 |
| Cipro | Ciprofloxacin | FOR SUSPENSION;ORAL | 020780 | BAYER HLTHCARE | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s093,020780s049lbl.pdf#page=40 |
| Cipro in Dextrose 5% in Plastic Container | Ciprofloxacin | INJECTABLE;INJECTION | 019857 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019857s066lbl.pdf#page=33 |
| Cipro in Dextrose 5% in Plastic Container | Ciprofloxacin | INJECTABLE;INJECTION | 019857 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019857s070lbl.pdf#page=33 |
| Cipro in Dextrose 5% in Plastic Container | Ciprofloxacin | INJECTABLE;INJECTION | 019857 | BAYER HLTHCARE | 05/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019857s072lbl.pdf#page=33 |
| Cipro XR | Ciprofloxacin; Ciprofloxacin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473 | BAYER HLTHCARE | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021473s043lbl.pdf#page=30 |
| Clenpiq | Citric Acid; Magnesium Oxide; Sodium Picosulfate | SOLUTION;ORAL | 209589 | FERRING PHARMS INC | 10/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf#page=14 |
| Clinoril | Sulindac | TABLET;ORAL | 017911 | MERCK | 12/23/2010 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf |
| Codeine Sulfate | Codeine Sulfate | TABLET;ORAL | 022402 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf#page=29 |
| Codeine Sulfate | Codeine Sulfate | SOLUTION;ORAL | 202245 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf#page=26 |
| Codeine Sulfate | Codeine Sulfate | SOLUTION;ORAL | 202245 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf#page=27 |
| Codeine Sulfate | Codeine Sulfate | SOLUTION;ORAL | 202245 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202245s008lbl.pdf#page=28 |
| Codeine Sulfate | Codeine Sulfate | SOLUTION;ORAL | 202245 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202245s009lbl.pdf#page=29 |
| Colcrys | Colchicine | TABLET;ORAL | 022352 | TAKEDA PHARMS USA | 05/14/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf#page=24 |
| Colcrys | Colchicine | TABLET;ORAL | 022352 | TAKEDA PHARMS USA | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf#page=25 |
| Colcrys | Colchicine | TABLET; ORAL | 022353 | AR HOLDING CO INC | 10/16/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf |
| Combunox | Ibuprofen; Oxycodone Hydrochloride | TABLET;ORAL | 021378 | FOREST LABS | 09/02/2010 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088574.pdf |
| Concerta | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | JANSSEN PHARMS | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf#page=30 |
| Contrave | Bupropion Hydrochloride; Naltrexone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NALPROPION | 08/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf#page=39 |
| Contrave | Bupropion Hydrochloride; Naltrexone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NALPROPION | 08/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf#page=40 |
| Conzip | Tramadol Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022370 | CIPHER PHARMS INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022370s018lbl.pdf#page=34 |
| Conzip | Tramadol Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022370 | CIPHER PHARMS INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s020lbl.pdf#page=35 |
| Copegus | Ribavirin | TABLET;ORAL | 021511 | ROCHE | 08/11/2015 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf#page=27 |
| Cordarone | Amiodarone Hydrochloride | TABLET;ORAL | 018972 | WYETH PHARMS | 10/17/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf#page=13 |
| Corlanor | Ivabradine Hydrochloride | TABLET;ORAL | 206143 | AMGEN INC | 05/13/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf#page=20 |
| Corlanor | Ivabradine Hydrochloride | TABLET;ORAL | 206143 | AMGEN INC | 05/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf#page=24 |
| Corlanor | Ivabradine | SOLUTION;ORAL | 209964 | AMGEN INC | 04/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209964lbl.pdf#page=24 |
| Cosentyx | Secukinumab | INJECTABLE;INJECTION | 125504 | NOVARTIS PHARMS CORP | 06/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf#page=20 |
| Cosentyx | Secukinumab | INJECTABLE;INJECTION | 125504 | NOVARTIS PHARMS CORP | 06/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf#page=22 |
| Cotempla XR-Odt | Methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489 | NEOS THERAPS INC | 06/19/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf#page=21 |
| Coumadin | Warfarin Sodium | INJECTABLE;INJECTION | 009218 | BRISTOL MYERS SQUIBB | 08/14/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30 |
| Coumadin | Warfarin Sodium | TABLET;ORAL | 009218 | BRISTOL MYERS SQUIBB | 08/14/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30 |
| Creon | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 020725 | ABBVIE | 03/20/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf#page=16 |
| Creon | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 020725 | ABBVIE | 03/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf#page=16 |
| Cyltezo | Adalimumab-Adbm | INJECTABLE;INJECTION | 761058 | BOEHRINGER INGELHEIM | 09/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf#page=30 |
| Cymbalta | Duloxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | LILLY | 10/01/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf#page=32 |
| Cymbalta | Duloxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | LILLY | 10/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021427s051lbl.pdf#page=33 |
| Cymbalta | Duloxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | LILLY | 10/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf#page=38 |
| Daliresp | Roflumilast | TABLET;ORAL | 022522 | ASTRAZENECA | 01/23/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf#page=17 |
| Dalmane | Flurazepam Hydrochloride | CAPSULE;ORAL | 016721 | VALEANT PHARM INTL | 03/27/2009 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf |
| Darvocet-N 100 | Acetaminophen; Propoxyphene Napsylate | TABLET;ORAL | 017122 | XANODYNE PHARM | 09/25/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf |
| Darvocet-N 50 | Acetaminophen; Propoxyphene Napsylate | TABLET;ORAL | 017122 | XANODYNE PHARM | 09/25/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf |
| Darvon | Propoxyphene Hydrochloride | CAPSULE;ORAL | 010997 | XANODYNE PHARM | 09/25/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf |
| Darvon-N | Propoxyphene Napsylate | TABLET;ORAL | 016862 | XANODYNE PHARM | 09/25/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf |
| Daurismo | Glasdegib Maleate | TABLET;ORAL | 210656 | PFIZER | 03/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf#page=20 |
| Daypro | Oxaprozin | TABLET;ORAL | 018841 | PFIZER | 05/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018841s030lbl.pdf#page=24 |
| Daypro Alta | Oxaprozin Potassium | TABLET;ORAL | 020776 | PFIZER | 05/03/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088580.pdf |
| Daypro Alta | Oxaprozin Potassium | TABLET;ORAL | 020776 | PFIZER | 05/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020776s008lbl.pdf#page=21 |
| Daytrana | Methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514 | NOVEN PHARMS INC | 10/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s028lbl.pdf#page=23 |
| Dayvigo | Lemborexant | TABLET;ORAL | 212028 | EISAI INC | 08/25/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212028s000lbl.pdf#page=21 |
| Demerol | Meperidine Hydrochloride | INJECTABLE;INJECTION | 005010 | VALIDUS PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32 |
| Demerol | Meperidine Hydrochloride | SYRUP;ORAL | 005010 | VALIDUS PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32 |
| Demerol | Meperidine Hydrochloride | TABLET;ORAL | 005010 | VALIDUS PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32 |
| Depakene | Valproic Acid | CAPSULE;ORAL | 018081 | ABBVIE | 05/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018081s070,018082s053lbl.pdf#page=41 |
| Depakene | Valproic Acid | SYRUP;ORAL | 018082 | ABBVIE | 05/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018081Orig1s068%20018082Orig1s051lbl.pdf#page=38 |
| Depakote | Divalproex Sodium | TABLET, DELAYED RELEASE;ORAL | 018723 | ABBVIE | 02/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018723s064lbl.pdf#page=48 |
| Depakote | Divalproex Sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 019680 | ABBVIE | 02/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s051lbl.pdf#page=42 |
| Depakote ER | Divalproex Sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | ABBVIE | 02/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s042lbl.pdf#page=48 |
| Descovy | Emtricitabine; Tenofovir Alafenamide Fumarate | TABLET;ORAL | 208215 | GILEAD SCIENCES INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf#page=37 |
| Desoxyn | Methamphetamine Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 005378 | RECORDATI RARE | 04/11/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf#page=12 |
| Desoxyn | Methamphetamine Hydrochloride | TABLET;ORAL | 005378 | RECORDATI RARE | 04/11/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf#page=12 |
| Desvenlafaxine | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204150 | ALEMBIC PHARMS LTD | 10/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf#page=30 |
| Desvenlafaxine | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204150 | ALEMBIC PHARMS LTD | 10/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204150s010lbl.pdf#page=31 |
| Desvenlafaxine | Desvenlafaxine Fumarate | TABLET, EXTENDED RELEASE;ORAL | 205208 | TEVA PHARMS USA | 07/18/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372058.pdf |
| Desvenlafaxine | Desvenlafaxine Fumarate | TABLET, EXTENDED RELEASE;ORAL | 205583 | SUN PHARMA GLOBAL | 12/10/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205583s010lbl.pdf#page=30 |
| Desyrel | Trazodone Hydrochloride | TABLET;ORAL | 018207 | PRAGMA | 10/18/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf#page=13 |
| Desyrel | Trazodone Hydrochloride | TABLET;ORAL | 018207 | PRAGMA | 10/18/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf#page=14 |
| Dexedrine | Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 017078 | IMPAX LABS INC | 01/15/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf#page=11 |
| Dexilant | Dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287 | TAKEDA PHARMS USA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s034lbl.pdf#page=23 |
| Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | SOLUTION;ORAL | 040776 | OUTLOOK PHARMS | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088583.pdf |
| Diacomit | Stiripentol | CAPSULE;ORAL | 206709 | BIOCODEX SA | 08/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17 |
| Diacomit | Stiripentol | FOR SUSPENSION;ORAL | 207223 | BIOCODEX SA | 08/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17 |
| Dilantin | Phenytoin Sodium | CAPSULE;ORAL | 084349 | UPJOHN | 08/07/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf#page=19 |
| Dilantin | Phenytoin | TABLET, CHEWABLE;ORAL | 084427 | PHARMACIA | 12/03/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf#page=17 |
| Dilantin-125 | Phenytoin | SUSPENSION;ORAL | 008762 | UPJOHN | 02/16/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18 |
| Dilantin-30 | Phenytoin | SUSPENSION;ORAL | 008762 | UPJOHN | 02/16/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18 |
| Dilaudid | Hydromorphone Hydrochloride | SOLUTION;ORAL | 019891 | RHODES PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf#page=30 |
| Dilaudid | Hydromorphone Hydrochloride | TABLET;ORAL | 019892 | RHODES PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf#page=30 |
| Dolophine Hydrochloride | Methadone Hydrochloride | SYRUP;ORAL | 006134 | HIKMA | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/006134s049lbl.pdf#page=34 |
| Dolophine Hydrochloride | Methadone Hydrochloride | TABLET;ORAL | 006134 | HIKMA | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/006134s049lbl.pdf#page=34 |
| Doral | Quazepam | TABLET;ORAL | 018708 | GALT PHARMS | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018708s027lbl.pdf#page=9 |
| Dotarem | Gadoterate Meglumine | SOLUTION;INTRAVENOUS | 204781 | GUERBET | 07/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s009lbl.pdf#page=29 |
| Dotarem | Gadoterate Meglumine | SOLUTION;INTRAVENOUS | 204781 | GUERBET | 07/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204781s012lbl.pdf#page=17 |
| Drizalma Sprinkle | Duloxetine Hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516 | SUN PHARMA GLOBAL | 06/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212516s000lbl.pdf#page=42 |
| Drizalma Sprinkle | Duloxetine Hydrochloride | CAPSULE, DELAYED RELEASE;ORAL | 212516 | SUN PHARMA GLOBAL | 06/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212516s001lbl.pdf#page=49 |
| Droxia | Hydroxyurea | CAPSULE;ORAL | 016295 | BRISTOL MYERS SQUIBB | 02/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf#page=27 |
| Duetact | Glimepiride; Pioglitazone Hydrochloride | TABLET;ORAL | 021925 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf#page=39 |
| Duexis | Famotidine; Ibuprofen | TABLET;ORAL | 022519 | HORIZON | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf#page=22 |
| Duexis | Famotidine; Ibuprofen | TABLET;ORAL | 022519 | HORIZON | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022519s012lbl.pdf#page=23 |
| Duragesic-100 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
| Duragesic-12 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
| Duragesic-25 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
| Duragesic-37 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
| Duragesic-50 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
| Duragesic-75 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
| Duzallo | Allopurinol; Lesinurad | TABLET;ORAL | 209203 | IRONWOOD PHARMS INC | 08/18/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209203s000lbl.pdf#page=27 |
| Dyanavel XR | Amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | TRIS PHARMA INC | 02/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf#page=15 |
| Dyanavel XR | Amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | TRIS PHARMA INC | 02/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/ 208147s005lbl.pdf#page=17 |
| Dysport | Abobotulinumtoxina | INJECTABLE; INJECTION | 125274 | IPSEN BIOPHARM LTD | 07/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125274s115lbl.pdf#page=31 |
| Dysport | Abobotulinumtoxina | INJECTABLE; INJECTION | 125274 | IPSEN BIOPHARM LTD | 07/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125274Orig1s118lbl.pdf#page=30 |
| EC-Naprosyn | Naproxen | TABLET, DELAYED RELEASE;ORAL | 020067 | ATNAHS PHARMA US | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22 |
| Edluar | Zolpidem Tartrate | TABLET;SUBLINGUAL | 021997 | MYLAN SPECIALITY LP | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf#page=23 |
| Effexor | Venlafaxine Hydrochloride | TABLET;ORAL | 020151 | WYETH PHARMS INC | 12/12/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf#page=34 |
| Effexor XR | Venlafaxine Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020699 | UPJOHN | 12/19/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf#page=36 |
| Effient | Prasugrel Hydrochloride | TABLET;ORAL | 022307 | DAIICHI SANKYO INC | 12/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022307s018lbl.pdf#page=21 |
| Elepsia XR | Levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417 | TRIPOINT | 12/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204417s000lbl.pdf#page=27 |
| Elepsia XR | Levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 204417 | TRIPOINT | 12/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204417s004lbl.pdf#page=25 |
| Elidel | Pimecrolimus | CREAM;TOPICAL | 021302 | BAUSCH | 06/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088587.pdf |
| Eliquis | Apixaban | TABLET;ORAL | 202155 | BRISTOL MYERS SQUIBB | 11/26/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf#page=40 |
| Eliquis | Apixaban | TABLET;ORAL | 202155 | BRISTOL MYERS SQUIBB | 11/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s021lbl.pdf#page=41 |
| Eliquis | Apixaban | TABLET;ORAL | 202155 | BRISTOL MYERS SQUIBB | 11/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s024lbl.pdf#page=37 |
| Elmiron | Pentosan Polysulfate Sodium | CAPSULE;ORAL | 020193 | JANSSEN PHARMS | 03/12/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193s015lbl.pdf#page=11 |
| Elyxyb | Celecoxib | SOLUTION;ORAL | 212157 | DR REDDYS | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf#page=24 |
| Embeda | Morphine Sulfate; Naltrexone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321 | ALPHARMA PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf#page=28 |
| Embeda | Morphine Sulfate; Naltrexone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321 | ALPHARMA PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf#page=30 |
| Emsam | Selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336 | SOMERSET | 07/14/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf#page=34 |
| Emsam | Selegiline | SYSTEM; TRANSDERMAL | 021708 | SOMERSET | 02/27/2006 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf |
| Enbrel | Etanercept | SYRINGE | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34 |
| Enbrel | Etanercept | VIAL; SUBCUTANEOUS | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34 |
| Enbrel | Etanercept | SYRINGE | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34 |
| Enbrel | Etanercept | VIAL; SUBCUTANEOUS | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34 |
| Enbrel | Etanercept | SYRINGE | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35 |
| Enbrel | Etanercept | VIAL; SUBCUTANEOUS | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35 |
| Enhertu | Fam-Trastuzumab Deruxtecan-Nxki | INJECTABLE;INJECTION | 761139 | DAIICHI SANKYO | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf#page=20 |
| Entyvio | Vedolizumab | INJECTABLE;INJECTION | 125476 | TAKEDA PHARMS USA | 03/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf#page=20 |
| Entyvio | Vedolizumab | INJECTABLE;INJECTION | 125476 | TAKEDA PHARMS USA | 03/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125476s024lbl.pdf#page20 |
| Entyvio | Vedolizumab | INJECTABLE;INJECTION | 125476 | TAKEDA PHARMS USA | 03/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf#page=20 |
| Envarsus XR | Tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406 | VELOXIS PHARMS INC | 09/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206406s007lbl.pdf#page=29 |
| Eovist | Gadoxetate Disodium | SOLUTION;INTRAVENOUS | 022090 | BAYER HLTHCARE | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf#page=51 |
| Epidiolex | Cannabidiol | SOLUTION;ORAL | 210365 | GW RES LTD | 10/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s008lbl.pdf#page=29 |
| Epogen/Procrit | Epoetin Alfa | VIAL; MULTIDOSE | 103234 | AMGEN | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27 |
| Epogen/Procrit | Epoetin Alfa | VIAL; SINGLE-USE | 103234 | AMGEN | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27 |
| Epzicom | Abacavir Sulfate; LAmivudine | TABLET;ORAL | 021652 | VIIV HLTHCARE | 02/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf#page=28 |
| Epzicom | Abacavir Sulfate; LAmivudine | TABLET;ORAL | 021652 | VIIV HLTHCARE | 02/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s028lbl.pdf#page=27 |
| Equetro | Carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710 | VALIDUS PHARMS | 09/23/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf#page=22 |
| Erelzi | Etanercept-Szzs | INJECTABLE; INJECTION | 761042 | SANDOZ | 06/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761042s012lbl.pdf#page=39 |
| Erivedge | Vismodegib | CAPSULE;ORAL | 203388 | GENENTECH | 07/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf#page=12 |
| Erivedge | Vismodegib | CAPSULE;ORAL | 203388 | GENENTECH | 07/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s012lbl.pdf#page=13 |
| Erivedge | Vismodegib | CAPSULE;ORAL | 203388 | GENENTECH | 07/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s014lbl.pdf#page=13 |
| Erivedge | Vismodegib | CAPSULE;ORAL | 203388 | GENENTECH | 07/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203388s016lbl.pdf#page=14 |
| Esomeprazole Strontium | Esomeprazole Strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342 | BELCHER | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202342s006lbl.pdf#page=29 |
| Estazolam | Estazolam | TABLET;ORAL | 074921 | MAYNE PHARMA | 02/05/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359235.pdf |
| Eticovo | Etanercept-Ykro | INJECTABLE;INJECTION | 761066 | SAMSUNG BIOEPIS CO LTD | 04/25/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf#page=31 |
| Evekeo ODT | Amphetamine Sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905 | ARBOR PHARMS LLC | 01/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209905s000lbl.pdf#page=15 |
| Evenity | Romosozumab-Aqqg | INJECTABLE;INJECTION | 761062 | AMGEN INC | 12/20/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761062s000lbl.pdf#page=19 |
| Evista | Raloxifene Hydrochloride | TABLET;ORAL | 020815 | LILLY | 06/27/2018 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf |
| Evista | Raloxifene Hydrochloride | TABLET; ORAL | 022042 | LILLY | 09/13/2007 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf |
| Exalgo | Hydromorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217 | SPECGX LLC | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf#page=31 |
| Exjade | Deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882 | NOVARTIS | 07/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021882s033lbl.pdf#page=28 |
| Extavia | Interferon Beta-1b | INJECTABLE; SUBCUTANEOUS | 125290 | NOVARTIS PHARMS | 10/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125290s070lbl.pdf#page=16 |
| Extraneal | Icodextrin | SOLUTION;INTRAPERITONEAL | 021321 | BAXTER HLTHCARE | 12/04/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135933.pdf |
| Factive | Gemifloxacin Mesylate | TABLET;ORAL | 021158 | LG CHEM LTD | 05/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf#page=30 |
| Farxiga | Dapagliflozin | TABLET;ORAL | 202293 | ASTRAZENECA AB | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf#page=38 |
| Farxiga | Dapagliflozin | TABLET;ORAL | 202293 | ASTRAZENECA AB | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf#page=47 |
| Farxiga | Dapagliflozin | TABLET;ORAL | 202293 | ASTRAZENECA AB | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.pdf#page=38 |
| Farxiga | Dapagliflozin | TABLET;ORAL | 202293 | ASTRAZENECA AB | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s022lbl.pdf#page=38 |
| Farydak | Panobinostat LActate | CAPSULE;ORAL | 205353 | SECURA | 06/06/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf |
| Felbatol | Felbamate | SUSPENSION;ORAL | 020189 | MYLAN SPECIALITY LP | 08/31/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf |
| Felbatol | Felbamate | TABLET;ORAL | 020189 | MYLAN SPECIALITY LP | 08/31/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf |
| Feldene | Piroxicam | CAPSULE;ORAL | 018147 | PFIZER | 05/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018147s048lbl.pdf#page=16 |
| Fensolvi Kit | Leuprolide Acetate | POWDER;SUBCUTANEOUS | 213150 | TOLMAR | 05/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213150s000lbl.pdf#page=15 |
| Fentanyl Citrate | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312 | PAR PHARM | 09/07/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf |
| Fentanyl Citrate | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907 | SPECGX LLC | 12/23/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf |
| Fentora | Fentanyl Citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | CEPHALON | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021947s034lbl.pdf#page=42 |
| Ferriprox | Deferiprone | TABLET;ORAL | 021825 | CHIESI | 02/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021825s004lbl.pdf#page=11 |
| Ferriprox | Deferiprone | TABLET;ORAL | 021825 | CHIESI | 02/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/ 021825s007lbl.pdf#page=21 |
| Ferriprox | Deferiprone | SOLUTION;ORAL | 208030 | CHIESI | 02/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf#page=11 |
| Ferriprox | Deferiprone | SOLUTION;ORAL | 208030 | CHIESI | 02/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208030s004lbl.pdf#page=11 |
| Ferriprox | Deferiprone | TABLET;ORAL | 212269 | CHIESI | 05/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212266s000lbl.pdf#page=14 |
| Fetzima | Levomilnacipran Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168 | ALLERGAN | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204168s006lbl.pdf#page=28 |
| Fintepla | Fenfluramine Hydrochloride | SOLUTION;ORAL | 212102 | ZOGENIX INC | 06/25/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf#page=23 |
| Fioricet W/ Codeine | Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | CAPSULE;ORAL | 020232 | ACTAVIS LABS UT INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf#page=41 |
| Fioricet W/ Codeine | Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | CAPSULE;ORAL | 020232 | ACTAVIS LABS UT INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf#page=42 |
| Fiorinal W/Codeine | Aspirin; Butalbital; Caffeine; Codeine Phosphate | CAPSULE;ORAL | 019429 | ALLERGAN | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf#page=39 |
| Firdapse | Amifampridine Phosphate | TABLET;ORAL | 208078 | CATALYST PHARMS | 03/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf#page=11 |
| Flector | Diclofenac Epolamine | SYSTEM;TOPICAL | 021234 | INST BIOCHEM | 03/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf#page=21 |
| Flector | Diclofenac Epolamine | SYSTEM;TOPICAL | 021234 | INST BIOCHEM | 03/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf#page=22 |
| Flowtuss | Guaifenesin; Hydrocodone Bitartrate | SOLUTION;ORAL | 022424 | BKK PHARMS | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf#page=26 |
| Floxin | Ofloxacin | TABLET;ORAL | 019735 | JANSSEN PHARMS | 02/25/2011 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf |
| Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | TABLET;ORAL | 202133 | ALVOGEN | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf#page=40 |
| Focalin | Dexmethylphenidate Hydrochloride | TABLET;ORAL | 021278 | NOVARTIS | 11/19/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf#page=14 |
| Focalin | Dexmethylphenidate Hydrochloride | TABLET;ORAL | 021278 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf#page=15 |
| Focalin | Dexmethylphenidate Hydrochloride | TABLET;ORAL | 021278 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s026lbl.pdf#page=14 |
| Focalin XR | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802 | NOVARTIS | 11/19/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf#page=17 |
| Focalin XR | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf#page=19 |
| Focalin XR | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s036lbl.pdf#page=18 |
| Foradil | Formoterol Fumarate | POWDER;INHALATION | 020831 | NOVARTIS | 03/02/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf |
| Foradil Certihaler | Formoterol Fumarate | POWDER;INHALATION | 021592 | NOVARTIS | 06/02/2010 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088603.pdf |
| Forfivo XL | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022497 | ALVOGEN | 12/10/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf#page=32 |
| Forfivo XL | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022497 | ALVOGEN | 12/10/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022497s008lbl.pdf#page=33 |
| Forteo | Teriparatide | SOLUTION;SUBCUTANEOUS | 021318 | LILLY | 11/16/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf#page=16 |
| Fortesta | Testosterone | GEL, METERED;TRANSDERMAL | 021463 | ENDO PHARMS | 06/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf#page=21 |
| Fosamax | Alendronate Sodium | TABLET;ORAL | 020560 | MERCK AND CO INC | 08/16/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf |
| Fosamax | Alendronate Sodium | TABLET;ORAL | 020560 | MERCK AND CO INC | 08/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24 |
| Fosamax | Alendronate Sodium | SOLUTION;ORAL | 021575 | MERCK | 11/30/2015 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf |
| Fosamax | Alendronate Sodium | SOLUTION;ORAL | 021575 | MERCK | 11/30/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24 |
| Fosamax Plus D | Alendronate Sodium; Cholecalciferol | TABLET;ORAL | 021762 | MERCK | 08/16/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf |
| Fosamax Plus D | Alendronate Sodium; Cholecalciferol | TABLET;ORAL | 021762 | MERCK | 08/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021762s022lbl.pdf#page=23 |
| Fosrenol | Lanthanum Carbonate | TABLET, CHEWABLE;ORAL | 021468 | TAKEDA PHARMS USA | 05/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf#page=12 |
| Fosrenol | Lanthanum Carbonate | TABLET, CHEWABLE;ORAL | 021468 | TAKEDA PHARMS USA | 05/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf#page=12 |
| Fosrenol | Lanthanum Carbonate | TABLET, CHEWABLE;ORAL | 021468 | TAKEDA PHARMS USA | 05/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf#page=12 |
| Fosrenol | Lanthanum Carbonate | POWDER;ORAL | 204734 | TAKEDA PHARMS USA | 05/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf#page=12 |
| Fosrenol | Lanthanum Carbonate | POWDER;ORAL | 204734 | TAKEDA PHARMS USA | 05/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf#page=12 |
| Fycompa | Perampanel | TABLET;ORAL | 202834 | EISAI INC | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24 |
| Fycompa | Perampanel | TABLET;ORAL | 202834 | EISAI INC | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24 |
| Fycompa | Perampanel | TABLET;ORAL | 202834 | EISAI INC | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf#page=24 |
| Fycompa | Perampanel | SUSPENSION;ORAL | 208277 | EISAI INC | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24 |
| Fycompa | Perampanel | SUSPENSION;ORAL | 208277 | EISAI INC | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24 |
| Fycompa | Perampanel | SUSPENSION;ORAL | 208277 | EISAI INC | 05/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf#page=24 |
| Gabitril | Tiagabine Hydrochloride | TABLET;ORAL | 020646 | CEPHALON | 08/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229203.pdf |
| Gadavist | Gadobutrol | SOLUTION;INTRAVENOUS | 201277 | BAYER HLTHCARE | 07/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201277s018lbl.pdf#page=22 |
| Gattex Kit | Teduglutide Recombinant | POWDER;SUBCUTANEOUS | 203441 | NPS PHARMS INC | 02/11/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333533.pdf |
| Gattex Kit | Teduglutide Recombinant | POWDER;SUBCUTANEOUS | 203441 | NPS PHARMS INC | 02/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203341s018lbl.pdf#page=17 |
| Gilenya | Fingolimod Hydrochloride | CAPSULE;ORAL | 022527 | NOVARTIS | 12/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf#page=26 |
| Gimoti | Metoclopramide Hydrochloride | SPRAY, METERED;NASAL | 209388 | EVOKE PHARMA INC | 01/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209388s001lbl.pdf#page=17 |
| Gloperba | Colchicine | SOLUTION;ORAL | 210942 | AVION PHARMS | 01/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210942s000lbl.pdf#page=11 |
| Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf#page=31 |
| Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf#page=32 |
| Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf#page=32 |
| Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s021lbl.pdf#page=33 |
| Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf#page=33 |
| Golytely | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous | FOR SOLUTION;ORAL | 019011 | BRAINTREE | 06/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019011s031lbl.pdf#page=9 |
| Gralise | Gabapentin | TABLET;ORAL | 022544 | ALMATICA | 04/02/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM245196.pdf |
| H.P. Acthar Gel | Corticotropin | INJECTABLE;INJECTION | 008372 | MALLINCKRODT ARD | 03/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s068lbl.pdf#page=18 |
| H.P. Acthar Gel | Repository Corticotropin | INJECTABLE; INJECTION | 022432 | QUESTCOR PHARMA | 10/15/2010 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf |
| Hadlima | Adalimumab-Bwwd | INJECTABLE;INJECTION | 761059 | SAMSUNG BIOEPIS CO LTD | 07/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf#page=36 |
| Halcion | Triazolam | TABLET;ORAL | 017892 | PFIZER | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s055lbl.pdf#page=20 |
| Halflytely | Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | 021551 | BRAINTREE | 06/03/2013 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM220644.pdf |
| Hemlibra | Emicizumab | INJECTABLE;INJECTION | 761083 | GENENTECH INC | 10/04/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf#page=21 |
| Horizant | Gabapentin Enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399 | ARBOR PHARMS LLC | 04/17/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250398.pdf |
| Horizant | Gabapentin Enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399 | ARBOR PHARMS LLC | 04/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s010lbl.pdf#page=27 |
| Hulio | Adalimumab-Fkjp | INJECTABLE;INJECTION | 761154 | MYLAN PHARMS INC | 07/06/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf#page=41 |
| Humira | Adalimumab | SYRINGE | 125057 | ABBVIE INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53 |
| Humira | Adalimumab | VIAL | 125057 | ABBVIE INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53 |
| Humira | Adalimumab | SYRINGE | 125057 | ABBVIE INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=56 |
| Humira | Adalimumab | VIAL | 125057 | ABBVIE INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=56 |
| Humira | Adalimumab | SYRINGE | 125057 | ABBVIE INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf#page=60 |
| Humira | Adalimumab | VIAL | 125057 | ABBVIE INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf#page=60 |
| Hycodan | Homatropine METhylbromide; Hydrocodone Bitartrate | SYRUP;ORAL | 005213 | GENUS | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27 |
| Hycodan | Homatropine METhylbromide; Hydrocodone Bitartrate | TABLET;ORAL | 005213 | GENUS | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27 |
| Hydrea | Hydroxyurea | CAPSULE;ORAL | 016295 | BRISTOL MYERS SQUIBB | 02/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf#page=27 |
| Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204278 | PADDOCK LABS LLC | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf |
| Hyrimoz | Adalimumab-Adaz | INJECTABLE;INJECTION | 761071 | SANDOZ INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf#page=36 |
| Hyrimoz | Adalimumab-Adaz | INJECTABLE;INJECTION | 761071 | SANDOZ INC | 02/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761071s001lbl.pdf#page=6 |
| Hysingla ER | Hydrocodone Bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | PURDUE PHARMA LP | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206627s012lbl.pdf#page=39 |
| Ibsrela | Tenapanor Hydrochloride | TABLET;ORAL | 211801 | ARDELYX INC | 03/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211801s000lbl.pdf#page=13 |
| Iclusig | Ponatinib Hydrochloride | TABLET;ORAL | 203469 | ARIAD | 12/18/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf#page=24 |
| Iclusig | Ponatinib Hydrochloride | TABLET;ORAL | 203469 | ARIAD | 12/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s032lbl.pdf#page=29 |
| Iclusig | Ponatinib Hydrochloride | TABLET;ORAL | 203469 | ARIAD | 12/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s033lbl.pdf#page=29 |
| Iclusig | Ponatinib Hydrochloride | TABLET;ORAL | 203469 | ARIAD | 12/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s034lbl.pdf#page=35 |
| Idhifa | Enasidenib Mesylate | TABLET;ORAL | 209606 | CELGENE CORP | 11/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf#page=17 |
| Ilaris | Canakinumab | INJECTABLE; SUBCUTANEOUS | 125319 | NOVARTIS PHARMS | 09/18/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352352.pdf |
| Ilaris | Canakinumab | INJECTABLE; SUBCUTANEOUS | 125319 | NOVARTIS PHARMS | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf#page=20 |
| Ilaris | Canakinumab | INJECTABLE; SUBCUTANEOUS | 125319 | NOVARTIS PHARMS | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s097lbl.pdf#page=21 |
| Ilaris | Canakinumab | INJECTABLE; SUBCUTANEOUS | 125319 | NOVARTIS PHARMS | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf#page=19 |
| Ilumya | Tildrakizumab-Asmn | INJECTABLE;INJECTION | 761067 | SUN PHARMA GLOBAL | 03/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf#page=10 |
| Imfinzi | Durvalumab | INJECTABLE;INJECTION | 761069 | ASTRAZENECA UK LTD | 02/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf#page=24 |
| Imfinzi | Durvalumab | INJECTABLE;INJECTION | 761069 | ASTRAZENECA UK LTD | 02/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s012lbl.pdf#page=30 |
| Imfinzi | Durvalumab | INJECTABLE;INJECTION | 761069 | ASTRAZENECA UK LTD | 02/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s018lbl.pdf#page=29 |
| Imfinzi | Durvalumab | INJECTABLE;INJECTION | 761069 | ASTRAZENECA UK LTD | 02/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s020lbl.pdf#page=30 |
| Imfinzi | Durvalumab | INJECTABLE;INJECTION | 761069 | ASTRAZENECA UK LTD | 02/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf#page=32 |
| Imfinzi | Durvalumab | INJECTABLE;INJECTION | 761069 | ASTRAZENECA UK LTD | 02/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s029lbl.pdf#page=26 |
| Imipramine Hydrochloride | Imipramine Hydrochloride | TABLET;ORAL | 087846 | SPECGX LLC | 06/29/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf#page=3 |
| Incivek | Telaprevir | TABLET;ORAL | 201917 | VERTEX PHARMS | 03/25/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf |
| Indocin | Indomethacin | CAPSULE;ORAL | 016059 | EGALET | 03/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016059s100lbl.pdf#page=23 |
| Indocin | Indomethacin | SUPPOSITORY;RECTAL | 017814 | EGALET | 03/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017814s043lbl.pdf#page=23 |
| Indocin | Indomethacin | SUSPENSION;ORAL | 018332 | EGALET | 03/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018332s040lbl.pdf#page=23 |
| Indocin SR | Indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185 | EGALET | 03/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018185s057lbl.pdf#page=23 |
| Inflectra | Infliximab-Dyyb | INJECTABLE;INJECTION | 125544 | CELLTRION INC | 06/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM497384.pdf |
| Inflectra | Infliximab-Dyyb | INJECTABLE;INJECTION | 125544 | CELLTRION INC | 06/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s009lbl.pdf#page=59 |
| Inrebic | Fedratinib Hydrochloride | CAPSULE;ORAL | 212327 | IMPACT | 08/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf#page=22 |
| Intermezzo | Zolpidem Tartrate | TABLET;SUBLINGUAL | 022328 | PURDUE PHARMA | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf#page=20 |
| Intron A | Interferon Alfa-2b | VIAL | 103132 | SCHERING | 05/04/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf#page=40 |
| Invirase | Saquinavir Mesylate | CAPSULE;ORAL | 020628 | HOFFMANN LA ROCHE | 03/28/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf |
| Invirase | Saquinavir Mesylate | CAPSULE;ORAL | 020628 | HOFFMANN LA ROCHE | 03/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf#page=25 |
| Invirase | Saquinavir Mesylate | CAPSULE;ORAL | 020628 | HOFFMANN LA ROCHE | 03/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf#page=24 |
| Invirase | Saquinavir Mesylate | TABLET;ORAL | 021785 | HOFFMANN-LA ROCHE | 09/18/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf |
| Invirase | Saquinavir Mesylate | TABLET;ORAL | 021785 | HOFFMANN-LA ROCHE | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf#page=25 |
| Invirase | Saquinavir Mesylate | TABLET;ORAL | 021785 | HOFFMANN-LA ROCHE | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf#page=24 |
| Invirase | Saquinavir Mesylate | TABLET;ORAL | 021785 | HOFFMANN-LA ROCHE | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021785s024lbl.pdf#page=26 |
| Invirase | Saquinavir Mesylate | TABLET;ORAL | 021785 | HOFFMANN-LA ROCHE | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021785s025lbl.pdf#page=25 |
| Invokamet | Canagliflozin; METformin Hydrochloride | TABLET;ORAL | 204353 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf#page=59 |
| Invokamet | Canagliflozin; METformin Hydrochloride | TABLET;ORAL | 204353 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf#page=58 |
| Invokamet XR | Canagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf#page=59 |
| Invokamet XR | Canagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf#page=58 |
| Invokana | Canagliflozin | TABLET;ORAL | 204042 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204042s032lbl.pdf#page=49 |
| Invokana | Canagliflozin | TABLET;ORAL | 204042 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s034lbl.pdf#page=48 |
| Invokana | Canagliflozin | TABLET;ORAL | 204042 | JANSSEN PHARMS | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s036lbl.pdf#page=49 |
| Ixifi | Infliximab-Qbtx | INJECTABLE;INJECTION | 761072 | PFIZER INC | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761072s006lbl.pdf#page=43 |
| Jadenu | Deferasirox | TABLET;ORAL | 206910 | NOVARTIS PHARMS CORP | 07/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s012lbl.pdf#page=29 |
| Jadenu | Deferasirox | TABLET;ORAL | 206910 | NOVARTIS PHARMS CORP | 07/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206910s015lbl.pdf#page=31 |
| Jadenu Sprinkle | Deferasirox | GRANULE;ORAL | 207968 | NOVARTIS | 07/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf#page=29 |
| Jadenu Sprinkle | Deferasirox | GRANULE;ORAL | 207968 | NOVARTIS | 07/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf#page=31 |
| Janumet | Metformin Hydrochloride; Sitagliptin Phosphate | TABLET;ORAL | 022044 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022044s048lbl.pdf#page=33 |
| Janumet XR | Metformin Hydrochloride; Sitagliptin Phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf#page=32 |
| Janumet XR | Metformin Hydrochloride; Sitagliptin Phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf#page=33 |
| Januvia | Sitagliptin Phosphate | TABLET;ORAL | 021995 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf#page=24 |
| Januvia | Sitagliptin Phosphate | TABLET;ORAL | 021995 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s045lbl.pdf#page=27 |
| Januvia | Sitagliptin Phosphate | TABLET;ORAL | 021995 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf#page=24 |
| Januvia | Sitagliptin Phosphate | TABLET;ORAL | 021995 | MERCK SHARP DOHME | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021995s047lbl.pdf#page=26 |
| Jardiance | Empagliflozin | TABLET;ORAL | 204629 | BOEHRINGER INGELHEIM | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf#page=32 |
| Jardiance | Empagliflozin | TABLET;ORAL | 204629 | BOEHRINGER INGELHEIM | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf#page=34 |
| Jardiance | Empagliflozin | TABLET;ORAL | 204629 | BOEHRINGER INGELHEIM | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf#page=33 |
| Jentadueto | Linagliptin; METformin Hydrochloride | TABLET;ORAL | 201281 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s025lbl.pdf#page=20 |
| Jentadueto | Linagliptin; METformin Hydrochloride | TABLET;ORAL | 201281 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201281s024lbl.pdf#page=22 |
| Jentadueto XR | Linagliptin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208026s013lbl.pdf#page=20 |
| Jentadueto XR | Linagliptin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026 | BOEHRINGER INGELHEIM | 03/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208026s012lbl.pdf#page=22 |
| Jeuveau | Prabotulinumtoxina-Xvfs | INJECTABLE;INJECTION | 761085 | EVOLUS INC | 07/12/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761085s000lbl.pdf#page=9 |
| Jornay PM | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 209311 | IRONSHORE PHARMS | 05/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf#page=19 |
| Jornay PM | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 209311 | IRONSHORE PHARMS | 05/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209311s003lbl.pdf#page=19 |
| Juvisync | Simvastatin; Sitagliptin Phosphate | TABLET;ORAL | 202343 | MERCK SHARP DOHME | 02/24/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf |
| Juxtapid | Lomitapide Mesylate | CAPSULE;ORAL | 203858 | AMRYT | 12/20/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf#page=32 |
| Jynarque | Tolvaptan | TABLET;ORAL | 204441 | OTSUKA | 11/25/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf#page=18 |
| Kadian | Morphine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 020616 | ALLERGAN | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020616s065lbl.pdf#page=36 |
| Kalbitor | Ecallantide | INJECTABLE; INJECTION | 125277 | DYAX CORP. | 12/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf#page=13 |
| Kaletra | Lopinavir; Ritonavir | CAPSULE;ORAL | 021226 | ABBVIE | 10/21/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s048lbl.pdf#page=52 |
| Kaletra | Lopinavir; Ritonavir | CAPSULE;ORAL | 021226 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf#page=50 |
| Kaletra | Lopinavir; Ritonavir | CAPSULE;ORAL | 021226 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s047lbl.pdf#page=53 |
| Kaletra | Lopinavir; Ritonavir | CAPSULE;ORAL | 021226 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf#page=53 |
| Kaletra | Lopinavir; Ritonavir | SOLUTION;ORAL | 021251 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51 |
| Kaletra | Lopinavir; Ritonavir | SOLUTION;ORAL | 021251 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf#page=52 |
| Kaletra | Lopinavir; Ritonavir | SOLUTION;ORAL | 021251 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53 |
| Kaletra | Lopinavir; Ritonavir | TABLET;ORAL | 021906 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51 |
| Kaletra | Lopinavir; Ritonavir | TABLET;ORAL | 021906 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf#page=52 |
| Kaletra | Lopinavir; Ritonavir | TABLET;ORAL | 021906 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53 |
| Kazano | Alogliptin Benzoate; METformin Hydrochloride | TABLET;ORAL | 203414 | TAKEDA PHARMS USA | 07/01/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337729.pdf |
| Kazano | Alogliptin Benzoate; METformin Hydrochloride | TABLET;ORAL | 203414 | TAKEDA PHARMS USA | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf#page=32 |
| Keppra | Levetiracetam | TABLET;ORAL | 021035 | UCB INC | 09/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf#page=32 |
| Keppra | Levetiracetam | TABLET;ORAL | 021035 | UCB INC | 09/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf#page=31 |
| Keppra | Levetiracetam | SOLUTION;ORAL | 021505 | UCB INC | 09/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf#page=32 |
| Keppra | Levetiracetam | SOLUTION;ORAL | 021505 | UCB INC | 09/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf#page=31 |
| Keppra XR | Levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285 | UCB INC | 09/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022285s029lbl.pdf#page=26 |
| Kesimpta | Ofatumumab | SOLUTION;SUBCUTANEOUS | 125326 | NOVARTIS | 08/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf#page=13 |
| Ketek | Telithromycin | TABLET;ORAL | 021144 | SANOFI AVENTIS US | 11/04/2015 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088615.pdf |
| Ketek | Telithromycin | TABLET;ORAL | 021144 | SANOFI AVENTIS US | 11/04/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf#page=29 |
| Kevzara | Sarilumab | INJECTABLE;INJECTION | 761037 | SANOFI SYNTHELABO | 04/13/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf#page=27 |
| Keytruda | Pembrolizumab | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 125514 | MERCK SHARP DOHME | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s048lbl.pdf#page=94 |
| Keytruda | Pembrolizumab | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 125514 | MERCK SHARP DOHME | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf#page=102 |
| Khedezla | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204683 | OSMOTICA PHARM CORP | 01/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf#page=24 |
| Khedezla | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204683 | OSMOTICA PHARM CORP | 01/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204683s006lbl.pdf#page=24 |
| Klonopin | Clonazepam | TABLET;ORAL | 017533 | ROCHE | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf#page=22 |
| Klonopin Rapidly Disintegrating | Clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813 | ROCHE | 12/16/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf#page=20 |
| Kombiglyze XR | Metformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678 | ASTRAZENECA AB | 07/01/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280360.pdf |
| Kombiglyze XR | Metformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678 | ASTRAZENECA AB | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf#page=47 |
| Kombiglyze XR | Metformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678 | ASTRAZENECA AB | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf#page=47 |
| Korlym | Mifepristone | TABLET;ORAL | 202107 | CORCEPT THERAP | 11/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf#page=19 |
| Korlym | Mifepristone | TABLET;ORAL | 202107 | CORCEPT THERAP | 11/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202107s008lbl.pdf#page=20 |
| Krystexxa | Pegloticase | INJECTABLE; INJECTION | 125293 | HORIZON PHARMA | 07/13/2018 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227568.pdf |
| Krystexxa | Pegloticase | INJECTABLE; INJECTION | 125293 | HORIZON PHARMA | 07/13/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf#page=14 |
| Kynamro | Mipomersen Sodium | SOLUTION;SUBCUTANEOUS | 203568 | KASTLE THERAPS LLC | 03/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf |
| Lacosamide | Lacosamide | SOLUTION;ORAL | 204839 | AMNEAL PHARMS | 10/27/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LacosamideTabletsCVMedGuide.pdf |
| Lacosamide | Lacosamide | TABLET;ORAL | 204855 | ACTAVIS LABS FL INC | 10/27/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE TABLETSMedGuide.pdf |
| Lacosamide | Lacosamide | TABLET;ORAL | 204857 | AMNEAL PHARMS NY | 10/27/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE ORAL SOLUTIONMed Guide.pdf |
| Lamictal | Lamotrigine | TABLET;ORAL | 020241 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65 |
| Lamictal CD | Lamotrigine | TABLET, CHEWABLE;ORAL | 020764 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65 |
| Lamictal ODT | Lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64 |
| Lamictal ODT | Lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65 |
| Lamictal XR | Lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022115s029lbl.pdf#page=51 |
| Lamictal XR | Lamotrigine | TABLET, EXTENDED RELEASE; ORAL | 022509 | SMITHKLINE BEECHAM | 01/29/2010 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.pdf#page=39 |
| Lamisil | Terbinafine Hydrochloride | TABLET;ORAL | 020539 | NOVARTIS | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf#page=11 |
| Lamisil | Terbinafine Hydrochloride | GRANULE;ORAL | 022071 | NOVARTIS | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf#page=10 |
| Lamivudine, Nevirapine and Zidovudine | Lamivudine; Nevirapine; Zidovudine | TABLET;ORAL | 205626 | MICRO LABS | 08/13/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205626s000lbl.pdf#page=50 |
| Lariam | Mefloquine Hydrochloride | TABLET;ORAL | 019591 | ROCHE | 04/29/2011 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf#page=13 |
| Latuda | Lurasidone Hydrochloride | TABLET;ORAL | 200603 | SUNOVION PHARMS INC | 12/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf#page=62 |
| Lazanda | Fentanyl Citrate | SPRAY, METERED;NASAL | 022569 | BTCP PHARMA | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf#page=35 |
| Lazanda | Fentanyl Citrate | SPRAY, METERED;NASAL | 022569 | BTCP PHARMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022569s027lbl.pdf#page=33 |
| Lazanda | Fentanyl Citrate | SPRAY, METERED;NASAL | 022569 | BTCP PHARMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022569s030lbl.pdf#page=35 |
| Lemtrada | Alemtuzumab | INJECTABLE;INJECTION | 103948 | GENZYME | 03/12/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf#page=30 |
| Letairis | Ambrisentan | TABLET;ORAL | 022081 | GILEAD | 12/22/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf |
| Letairis | Ambrisentan | TABLET;ORAL | 022081 | GILEAD | 12/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf#page=26 |
| Levaquin | Levofloxacin | TABLET;ORAL | 020634 | JANSSEN PHARMS | 06/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf#page=51 |
| Levaquin | Levofloxacin | TABLET;ORAL | 020634 | JANSSEN PHARMS | 06/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s070lbl.pdf#page=52 |
| Levaquin | Levofloxacin | TABLET;ORAL | 020634 | JANSSEN PHARMS | 06/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s071lbl.pdf#page=53 |
| Levaquin | Levofloxacin | TABLET;ORAL | 020634 | JANSSEN PHARMS | 06/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020634s073lbl.pdf#page=54 |
| Levaquin | Levofloxacin | INJECTABLE;INJECTION | 020635 | JANSSEN PHARMS | 02/08/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf |
| Levaquin | Levofloxacin | SOLUTION;ORAL | 021721 | JANSSEN PHARMS | 02/08/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf |
| Levaquin in Dextrose 5% in Plastic Container | Levofloxacin | INJECTABLE;INJECTION | 020635 | JANSSEN PHARMS | 02/08/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf |
| Lexapro | Escitalopram Oxalate | TABLET;ORAL | 021323 | ALLERGAN | 08/28/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24 |
| Lexapro | Escitalopram Oxalate | SOLUTION;ORAL | 021365 | ALLERGAN | 08/28/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24 |
| Librax | Chlordiazepoxide Hydrochloride; Clidinium Bromide | CAPSULE;ORAL | 012750 | BAUSCH | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012750s067lbl.pdf#page=11 |
| Librium | Chlordiazepoxide Hydrochloride | CAPSULE;ORAL | 012249 | VALEANT PHARM INTL | 12/16/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf#page=8 |
| Libtayo | Cemiplimab-Rwlc | INJECTABLE;INTRAVENOUS | 761097 | REGENERON PHARMACEUTICALS | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s007lbl.pdf#page=29 |
| Licart | Diclofenac Epolamine | SYSTEM;TOPICAL | 206976 | IBSA INST BIO | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206976s000lbl.pdf#page=22 |
| Licart | Diclofenac Epolamine | SYSTEM;TOPICAL | 206976 | IBSA INST BIO | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206976s002lbl.pdf#page=20 |
| Limbitrol | Amitriptyline Hydrochloride; Chlordiazepoxide | TABLET;ORAL | 016949 | HERITAGE PHARMS INC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016949s041lbl.pdf#page=14 |
| Limbitrol DS | Amitriptyline Hydrochloride; Chlordiazepoxide | TABLET;ORAL | 016949 | HERITAGE PHARMS INC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016949s041lbl.pdf#page=14 |
| Lindane | Lindane | SHAMPOO;TOPICAL | 087266 | OLTA PHARMS | 04/05/2004 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneLotionMedGuide.pdf |
| Lindane | Lindane | LOTION;TOPICAL | 087313 | OLTA PHARMS | 09/04/2001 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneShampooMedGuide.pdf |
| Linzess | Linaclotide | CAPSULE;ORAL | 202811 | ALLERGAN | 09/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf#page=20 |
| Linzess | Linaclotide | CAPSULE;ORAL | 202811 | ALLERGAN | 09/22/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf#page=21 |
| Lithium Carbonate | Lithium Carbonate | CAPSULE;ORAL | 017812 | HIKMA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19 |
| Lithium Carbonate | Lithium Carbonate | CAPSULE;ORAL | 017812 | HIKMA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf#page=19 |
| Lithium Carbonate | Lithium Carbonate | CAPSULE;ORAL | 017812 | HIKMA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20 |
| Lithium Carbonate | Lithium Carbonate | TABLET;ORAL | 018558 | HIKMA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20 |
| Lithium Citrate | Lithium Citrate | SYRUP;ORAL | 018421 | HIKMA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20 |
| Lotronex | Alosetron Hydrochloride | TABLET;ORAL | 021107 | SEBELA IRELAND LTD | 04/03/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf |
| Lumoxiti | Moxetumomab Pasudotox-Tdfk | INJECTABLE;INJECTION | 761104 | INNATE PHARMA | 08/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf#page=18 |
| Lumoxiti | Moxetumomab Pasudotox-Tdfk | INJECTABLE;INJECTION | 761104 | INNATE PHARMA | 08/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s001lbl.pdf#page=18 |
| Lumoxiti | Moxetumomab Pasudotox-Tdfk | INJECTABLE;INJECTION | 761104 | INNATE PHARMA | 08/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf#page=18 |
| Lunesta | Eszopiclone | TABLET;ORAL | 021476 | SUNOVION PHARMS INC | 08/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134691.pdf |
| Lunesta | Eszopiclone | TABLET;ORAL | 021476 | SUNOVION PHARMS INC | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf#page=26 |
| Lupkynis | Voclosporin | CAPSULE;ORAL | 213716 | AURINIA | 01/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf#page=23 |
| Lupron | Leuprolide Acetate | INJECTABLE;INJECTION | 019010 | ABBVIE ENDOCRINE INC | 12/10/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf#page=27 |
| Lupron Depot-Ped Kit | Leuprolide Acetate | POWDER;INTRAMUSCULAR | 020263 | ABBVIE ENDOCRINE INC | 03/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf#page=20 |
| Lupron Depot-Ped Kit | Leuprolide Acetate | POWDER;INTRAMUSCULAR | 020263 | ABBVIE ENDOCRINE INC | 03/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020263s046lbl.pdf#page=21 |
| Lupron Depot-Ped Kit | Leuprolide Acetate | POWDER;INTRAMUSCULAR | 020263 | ABBVIE ENDOCRINE INC | 03/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020263s044s047lbl.pdf#page=22 |
| Luvox | Fluvoxamine Maleate | TABLET;ORAL | 021519 | ANI PHARMS | 12/16/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf#page=30 |
| Luvox | Fluvoxamine Maleate | TABLET;ORAL | 021519 | ANI PHARMS | 12/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf#page=32 |
| Luvox | Fluvoxamine Maleate | TABLET; ORAL | 022235 | JAZZ | 04/14/2008 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249169.pdf |
| Luvox CR | Fluvoxamine Maleate | CAPSULE, EXTENDED RELEASE;ORAL | 022033 | JAZZ PHARMS | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf#page=26 |
| Lynparza | Olaparib | CAPSULE;ORAL | 206162 | ASTRAZENECA | 09/27/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf#page=16 |
| Lynparza | Olaparib | CAPSULE;ORAL | 206162 | ASTRAZENECA | 09/27/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16 |
| Lynparza | Olaparib | TABLET;ORAL | 208558 | ASTRAZENECA | 03/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf#page=23 |
| Lynparza | Olaparib | TABLET;ORAL | 208558 | ASTRAZENECA | 03/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208558s019s020lbl.pdf#page=52 |
| Lyrica | Pregabalin | CAPSULE;ORAL | 021446 | PFIZER | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf#page=50 |
| Lyrica | Pregabalin | CAPSULE;ORAL | 021446 | PFIZER | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54 |
| Lyrica | Pregabalin | CAPSULE;ORAL | 021446 | PFIZER | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56 |
| Lyrica | Pregabalin | SOLUTION;ORAL | 022488 | PFIZER | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54 |
| Lyrica | Pregabalin | SOLUTION;ORAL | 022488 | PFIZER | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56 |
| Lyrica CR | Pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501 | PFIZER | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29 |
| Magnevist | Gadopentetate Dimeglumine | INJECTABLE;INJECTION | 019596 | BAYER HLTHCARE | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12 |
| Magnevist | Gadopentetate Dimeglumine | INJECTABLE;INJECTION | 021037 | BAYER HLTHCARE | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13 |
| Marplan | Isocarboxazid | TABLET;ORAL | 011961 | VALIDUS PHARMS INC | 11/08/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf#page=16 |
| Mavenclad | Cladribine | TABLET;ORAL | 022561 | EMD SERONO INC | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf#page=29 |
| Mayzent | Siponimod Fumaric Acid | TABLET;ORAL | 209884 | NOVARTIS | 01/23/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209884s000lbl.pdf#page=22 |
| Mayzent | Siponimod Fumaric Acid | TABLET;ORAL | 209884 | NOVARTIS | 01/23/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209884s003lbl.pdf#page=22 |
| Meridia | Sibutramine Hydrochloride | CAPSULE;ORAL | 020632 | ABBOTT | 08/04/2010 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf |
| Metadate CD | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259 | LANNETT CO INC | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf#page=20 |
| Methylin | Methylphenidate Hydrochloride | SOLUTION;ORAL | 021419 | SPECGX LLC | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf#page=12 |
| Methylin | Methylphenidate Hydrochloride | TABLET, CHEWABLE;ORAL | 021475 | SPECGX LLC | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf#page=13 |
| Metoclopramide Hydrochloride | Metoclopramide Hydrochloride | SOLUTION;ORAL | 074703 | WOCKHARDT BIO AG | 04/08/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM244086.pdf |
| Metozolv ODT | Metoclopramide Hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246 | SALIX PHARMS | 02/28/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187064.pdf |
| Metozolv ODT | Metoclopramide Hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 022246 | SALIX PHARMS | 02/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf#page=18 |
| Mifeprex | Mifepristone | TABLET;ORAL | 020687 | DANCO LABS LLC | 04/11/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf |
| Mifeprex | Mifepristone | TABLET;ORAL | 020687 | DANCO LABS LLC | 04/11/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020687s022lbl.pdf#page=16 |
| Mircera | Methoxy Polyethylene Glycol-Epoetin Beta | SOLUTION; INJECTION | 125164 | HOFFMAN-LA ROCHE | 06/07/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf#page=23 |
| Mitigare | Colchicine | CAPSULE;ORAL | 204820 | HIKMA INTL PHARMS | 09/26/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf |
| Mobic | Meloxicam | TABLET;ORAL | 020938 | BOEHRINGER INGELHEIM | 06/30/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf |
| Mobic | Meloxicam | SUSPENSION;ORAL | 021530 | AVONDALE PHARMS | 09/01/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf |
| Morphabond ER | Morphine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544 | DAIICHI SANKYO INC | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf#page=38 |
| Morphine Sulfate | Morphine Sulfate | SOLUTION;ORAL | 022195 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf#page=29 |
| Morphine Sulfate | Morphine Sulfate | TABLET;ORAL | 022207 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf#page=26 |
| Morphine Sulfate | Morphine Sulfate | SOLUTION;ORAL | 201517 | LANNETT CO INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf#page=28 |
| Morphine Sulfate | Morphine Sulfate | SOLUTION;ORAL | 201517 | LANNETT CO INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf#page=29 |
| Motrin | Ibuprofen | TABLET;ORAL | 017463 | MCNEIL CONSUMER | 09/10/2007 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088647.pdf |
| Movantik | Naloxegol Oxalate | TABLET;ORAL | 204760 | REDHILL | 04/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf#page=16 |
| Movantik | Naloxegol Oxalate | TABLET;ORAL | 204760 | REDHILL | 04/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf#page=16 |
| Movantik | Naloxegol Oxalate | TABLET;ORAL | 204760 | REDHILL | 04/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf#page=16 |
| Moviprep | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | FOR SOLUTION;ORAL | 021881 | SALIX PHARMS | 11/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021881s017lbl.pdf#page=13 |
| Moxifloxacin Hydrochloride | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 205572 | FRESENIUS KABI USA | 03/27/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088619.pdf |
| Moxifloxacin Hydrochloride | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 205572 | FRESENIUS KABI USA | 03/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205572s006lbl.pdf#page=49 |
| Moxifloxacin Hydrochloride | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 205572 | FRESENIUS KABI USA | 03/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205572s007lbl.pdf#page=49 |
| MS Contin | Morphine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 019516 | PURDUE PHARMA LP | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019516s057lbl.pdf#page=29 |
| Multaq | Dronedarone Hydrochloride | TABLET;ORAL | 022425 | SANOFI AVENTIS US | 11/16/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=22 |
| Multihance | Gadobenate Dimeglumine | INJECTABLE;INTRAVENOUS | 021357 | BRACCO | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34 |
| Multihance Multipack | Gadobenate Dimeglumine | INJECTABLE;INTRAVENOUS | 021358 | BRACCO | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34 |
| Myalept | Metreleptin | INJECTABLE;INJECTION | 125390 | AEGERION | 07/13/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf#page=14 |
| Mydayis | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063 | TAKEDA PHARMS USA | 09/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf#page=22 |
| Myfortic | Mycophenolic Acid | TABLET, DELAYED RELEASE;ORAL | 050791 | NOVARTIS | 01/15/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172735.pdf |
| Myfortic | Mycophenolic Acid | TABLET, DELAYED RELEASE;ORAL | 050791 | NOVARTIS | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf#page=25 |
| Myfortic | Mycophenolic Acid | TABLET, DELAYED RELEASE;ORAL | 050791 | NOVARTIS | 01/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050791s030lbl.pdf#page=24 |
| Myobloc | Botulinum Toxin Type B | VIAL | 103846 | ELAN PHARM | 03/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf#page=18 |
| Myobloc | Botulinum Toxin Type B | VIAL | 103846 | ELAN PHARM | 03/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf#page=17 |
| Mysoline | Primidone | TABLET;ORAL | 009170 | VALEANT | 06/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf#page=7 |
| Nalfon | Fenoprofen Calcium | CAPSULE;ORAL | 017604 | XSPIRE PHARMA | 05/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf |
| Naprelan | Naproxen Sodium | TABLET, EXTENDED RELEASE;ORAL | 020353 | ALMATICA | 07/22/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280324.pdf |
| Naprelan | Naproxen Sodium | TABLET, EXTENDED RELEASE;ORAL | 020353 | ALMATICA | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf#page=21 |
| Naprosyn | Naproxen | TABLET;ORAL | 017581 | ATNAHS PHARMA US | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22 |
| Naprosyn | Naproxen | SUSPENSION;ORAL | 018965 | ATNAHS PHARMA US | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018965s025lbl.pdf#page=21 |
| Nardil | Phenelzine Sulfate | TABLET;ORAL | 011909 | PARKE DAVIS | 08/02/2007 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088660.pdf |
| Natpara | Parathyroid Hormone | INJECTABLE;INJECTION | 125511 | NPS PHARMS INC | 07/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf#page=18 |
| Natpara | Parathyroid Hormone | INJECTABLE;INJECTION | 125511 | NPS PHARMS INC | 07/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s016lbl.pdf#page=18 |
| Natpara | Parathyroid Hormone | INJECTABLE;INJECTION | 125511 | NPS PHARMS INC | 07/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/natparaMedGuide.pdf |
| Nayzilam | Midazolam | SPRAY;NASAL | 211321 | UCB INC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211321s000lbl.pdf#page=24 |
| Nayzilam | Midazolam | SPRAY;NASAL | 211321 | UCB INC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211321s005lbl.pdf#page=27 |
| Nerlynx | Neratinib Maleate | TABLET;ORAL | 208051 | PUMA BIOTECH | 07/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf#page=19 |
| Nesina | Alogliptin Benzoate | TABLET;ORAL | 022271 | TAKEDA PHARMS USA | 07/01/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337732.pdf |
| Nesina | Alogliptin Benzoate | TABLET;ORAL | 022271 | TAKEDA PHARMS USA | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf#page=29 |
| Neurontin | Gabapentin | CAPSULE;ORAL | 020235 | UPJOHN | 12/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf#Page=28 |
| Neurontin | Gabapentin | TABLET;ORAL | 020882 | UPJOHN | 12/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf#Page=28 |
| Neurontin | Gabapentin | SOLUTION;ORAL | 021129 | UPJOHN | 12/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf#Page=28 |
| Nexium | Esomeprazole Magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153 | ASTRAZENECA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf#page=33 |
| Nexium | Esomeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957 | ASTRAZENECA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf#page=33 |
| Nexium | Esomeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022101 | ASTRAZENECA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf#page=33 |
| Nizoral | Ketoconazole | TABLET;ORAL | 018533 | JANSSEN PHARMS | 02/25/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf |
| Nocdurna | Desmopressin Acetate | TABLET;SUBLINGUAL | 022517 | FERRING PHARMS INC | 06/21/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf#page=14 |
| Noctiva | Desmopressin Acetate | SPRAY, METERED;NASAL | 201656 | ROIVANT | 03/03/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf#page=13 |
| Nolvadex | Tamoxifen Citrate | TABLET;ORAL | 017970 | ASTRAZENECA | 03/13/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088661.pdf |
| Norco | Acetaminophen; Hydrocodone Bitartrate | TABLET;ORAL | 040099 | APIL | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040099s023lbl.pdf#page=23 |
| Noroxin | Norfloxacin | TABLET;ORAL | 019384 | MERCK | 07/26/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf |
| Norpramin | Desipramine Hydrochloride | TABLET;ORAL | 014399 | VALIDUS PHARMS | 11/09/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf |
| Novantrone | Mitoxantrone Hydrochloride | INJECTABLE;INJECTION | 019297 | EMD SERONO | 03/23/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035mg.pdf |
| Nplate | Romiplostim | INJECTABLE; SUBCUTANEOUS | 125268 | AMGEN | 02/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s167lbl.pdf#page=18 |
| Nucynta | Tapentadol Hydrochloride | TABLET;ORAL | 022304 | COLLEGIUM PHARM INC | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf#page=32 |
| Nucynta | Tapentadol Hydrochloride | TABLET;ORAL | 022304 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf#page=32 |
| Nucynta | Tapentadol Hydrochloride | TABLET;ORAL | 022304 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022304s022lbl.pdf#page=33 |
| Nucynta | Tapentadol Hydrochloride | TABLET;ORAL | 022304 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022304s023lbl.pdf#page=33 |
| Nucynta | Tapentadol Hydrochloride | SOLUTION;ORAL | 203794 | COLLEGIUM PHARM INC | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000mg.pdf |
| Nucynta | Tapentadol Hydrochloride | SOLUTION;ORAL | 203794 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203794s009lbl.pdf#page=35 |
| Nucynta ER | Tapentadol Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200533s020lbl.pdf#page=34 |
| Nucynta ER | Tapentadol Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200533s023lbl.pdf#page=37 |
| Nulojix | Belatacept | INJECTABLE; INJECTION | 125288 | BRISTOL MYERS SQUIBB | 04/13/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49 |
| Nulytely | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | FOR SOLUTION;ORAL | 019797 | BRAINTREE | 09/23/2013 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf |
| Nulytely-Flavored | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | FOR SOLUTION;ORAL | 019797 | BRAINTREE | 09/23/2013 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf |
| Nuvigil | Armodafinil | TABLET;ORAL | 021875 | CEPHALON | 02/07/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231717.pdf |
| Obredon | Guaifenesin; Hydrocodone Bitartrate | SOLUTION;ORAL | 205474 | SOVEREIGN PHARMS | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205474s005lbl.pdf#page=23 |
| Ocaliva | Obeticholic Acid | TABLET;ORAL | 207999 | INTERCEPT PHARMS INC | 02/01/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf#page=23 |
| Ocrevus | Ocrelizumab | INJECTABLE;INJECTION | 761053 | GENENTECH INC | 12/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf#page=17 |
| Ocrevus | Ocrelizumab | INJECTABLE;INJECTION | 761053 | GENENTECH INC | 12/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf#page=17 |
| Ocrevus | Ocrelizumab | INJECTABLE;INJECTION | 761053 | GENENTECH INC | 12/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s023lbl.pdf#page=19 |
| Ocrevus | Ocrelizumab | INJECTABLE;INJECTION | 761053 | GENENTECH INC | 12/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf#page=18 |
| Odomzo | Sonidegib Phosphate | CAPSULE;ORAL | 205266 | SUN PHARMA GLOBAL | 05/13/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf#page=12 |
| Odomzo | Sonidegib Phosphate | CAPSULE;ORAL | 205266 | SUN PHARMA GLOBAL | 05/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266Orig1s000lbl.pdf#page=12 |
| Odomzo | Sonidegib Phosphate | CAPSULE;ORAL | 205266 | SUN PHARMA GLOBAL | 05/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205266s006lbl.pdf#page=13 |
| Oleptro | Trazodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411 | ANGELINI PHARMA | 07/17/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf |
| Olumiant | Baricitinib | TABLET;ORAL | 207924 | ELI LILLY AND CO | 07/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207924s001lbl.pdf#page=18 |
| Olumiant | Baricitinib | TABLET;ORAL | 207924 | ELI LILLY AND CO | 07/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207924s002lbl.pdf#page=18 |
| Omniscan | Gadodiamide | INJECTABLE;INJECTION | 020123 | GE HEALTHCARE | 11/07/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1 |
| Omniscan | Gadodiamide | INJECTABLE;INJECTION | 022066 | GE HEALTHCARE | 10/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1 |
| Omontys | Peginesatide Acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799 | TAKEDA PHARMS USA | 12/04/2012 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf |
| Omontys Preservative Free | Peginesatide Acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799 | TAKEDA PHARMS USA | 12/04/2012 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf |
| Onfi | Clobazam | TABLET;ORAL | 202067 | LUNDBECK PHARMS LLC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29 |
| Onfi | Clobazam | TABLET;ORAL | 202067 | LUNDBECK PHARMS LLC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf#page=30 |
| Onfi | Clobazam | SUSPENSION;ORAL | 203993 | LUNDBECK PHARMS LLC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29 |
| Onfi | Clobazam | SUSPENSION;ORAL | 203993 | LUNDBECK PHARMS LLC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf#page=30 |
| Onglyza | Saxagliptin Hydrochloride | TABLET;ORAL | 022350 | ASTRAZENECA AB | 07/01/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf#page=31 |
| Onglyza | Saxagliptin Hydrochloride | TABLET;ORAL | 022350 | ASTRAZENECA AB | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf#page=31 |
| Onsolis | Fentanyl Citrate | FILM;BUCCAL | 022266 | BDSI | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf#page=32 |
| Opana | Oxymorphone Hydrochloride | TABLET;ORAL | 021611 | ENDO PHARMS | 10/25/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf#page=27 |
| Opana ER | Oxymorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610 | ENDO PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021610s028lbl.pdf#page=31 |
| Opana ER | Oxymorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655 | ENDO PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf#page=26 |
| Opdivo | Nivolumab | INJECTABLE;INJECTION | 125554 | BRISTOL MYERS SQUIBB | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s095lbl.pdf#page=99 |
| Opdivo | Nivolumab | INJECTABLE;INJECTION | 125554 | BRISTOL MYERS SQUIBB | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s090lbl.pdf#page=106 |
| Opsumit | Macitentan | TABLET;ORAL | 204410 | ACTELION | 04/08/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204410s010lbl.pdf#page=20 |
| Optimark | Gadoversetamide | INJECTABLE;INJECTION | 020937 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf#page=13 |
| Optimark | Gadoversetamide | INJECTABLE;INJECTION | 020937 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=14 |
| Optimark | Gadoversetamide | INJECTABLE;INJECTION | 020975 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=29 |
| Optimark | Gadoversetamide | INJECTABLE;INJECTION | 020975 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf#page=13 |
| Optimark in Plastic Container | Gadoversetamide | INJECTABLE;INJECTION | 020976 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=43 |
| Optimark in Plastic Container | Gadoversetamide | INJECTABLE;INJECTION | 020976 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf#page=13 |
| Oriahnn (Copackaged) | Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | CAPSULE;ORAL | 213388 | ABBVIE INC | 05/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213388s000lbl.pdf#page=29 |
| Orilissa | Elagolix Sodium | TABLET;ORAL | 210450 | ABBVIE INC | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210450s002lbl.pdf#page=27 |
| Orilissa | Elagolix Sodium | TABLET;ORAL | 210450 | ABBVIE INC | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf#page=27 |
| Oseni | Alogliptin Benzoate; Pioglitazone Hydrochloride | TABLET;ORAL | 022426 | TAKEDA PHARMS USA | 07/01/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf#page=42 |
| Oseni | Alogliptin Benzoate; Pioglitazone Hydrochloride | TABLET;ORAL | 022426 | TAKEDA PHARMS USA | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf#page=43 |
| Osmoprep | Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | TABLET;ORAL | 021892 | SALIX PHARMS | 11/29/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006mg.pdf |
| Osmoprep | Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | TABLET;ORAL | 021892 | SALIX PHARMS | 11/29/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf#page=13 |
| Oxaydo | Oxycodone Hydrochloride | TABLET;ORAL | 202080 | ZYLA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202080s012lbl.pdf#page=30 |
| Oxtellar XR | Oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 202810 | SUPERNUS PHARMS | 12/13/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf |
| Oxycodone Hydrochloride | Oxycodone Hydrochloride | CAPSULE;ORAL | 200534 | GENUS LIFESCIENCES | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf#page=29 |
| Oxycodone Hydrochloride | Oxycodone Hydrochloride | CAPSULE;ORAL | 200534 | GENUS LIFESCIENCES | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s011lbl.pdf#page=30 |
| Oxycodone Hydrochloride | Oxycodone Hydrochloride | SOLUTION;ORAL | 200535 | GENUS LIFESCIENCES | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000MedGuide.pdf |
| Oxycodone Hydrochloride | Oxycodone Hydrochloride | SOLUTION;ORAL | 200535 | GENUS LIFESCIENCES | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200535s019lbl.pdf#page=34 |
| Oxycodone Hydrochloride | Oxycodone Hydrochloride | SOLUTION;ORAL | 201194 | VISTAPHARM | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf#page=32 |
| Oxycontin | Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | PURDUE PHARMA LP | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022272s042MG.pdf |
| Oxycontin | Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | PURDUE PHARMA LP | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s046lbl.pdf#page=48 |
| Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079046 | ACTAVIS ELIZABETH | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf |
| Ozempic | Semaglutide | SOLUTION;SUBCUTANEOUS | 209637 | NOVO | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf#page=24 |
| Ozempic | Semaglutide | SOLUTION;SUBCUTANEOUS | 209637 | NOVO | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf#page=24 |
| Pacerone | Amiodarone Hydrochloride | TABLET;ORAL | 075135 | UPSHER SMITH LABS | 11/01/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf |
| Palladone | Hydromorphone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021044 | PURDUE PHARMA LP | 04/16/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf |
| Palynziq | Pegvaliase-Pqpz | INJECTABLE;INJECTION | 761079 | BIOMARIN PHARM | 11/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf#page=23 |
| Pamelor | Nortriptyline Hydrochloride | SOLUTION;ORAL | 018012 | SPECGX LLC | 07/28/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf |
| Pamelor | Nortriptyline Hydrochloride | CAPSULE;ORAL | 018013 | SPECGX LLC | 04/09/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf#page=15 |
| Pancreaze | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022523 | VIVUS INC | 03/20/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523MedGuide.pdf |
| Pancreaze | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022523 | VIVUS INC | 03/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf#page=16 |
| Parnate | Tranylcypromine Sulfate | TABLET;ORAL | 012342 | CONCORDIA | 01/04/2018 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088674.pdf |
| Paxil | Paroxetine Hydrochloride | TABLET;ORAL | 020031 | APOTEX TECHNOLOGIES | 02/06/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s077lbl.pdf#page=45 |
| Paxil | Paroxetine Hydrochloride | SUSPENSION;ORAL | 020710 | APOTEX TECHNOLOGIES | 02/06/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43 |
| Paxil | Paroxetine Hydrochloride | SUSPENSION;ORAL | 020710 | APOTEX TECHNOLOGIES | 02/06/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031Orig1s077,020710Orig1s045lbl.pdf#page=45 |
| Paxil CR | Paroxetine Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936 | APOTEX TECHNOLOGIES | 09/11/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020936s047lbl.pdf#page=29 |
| Peganone | Ethotoin | TABLET;ORAL | 010841 | RECORDATI RARE | 02/27/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf |
| Pegasys | Peginterferon Alfa-2a | SYRINGE | 103964 | HOFFMAN-LA ROCHE | 03/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39 |
| Pegasys | Peginterferon Alfa-2a | VIAL; SUBCUTANEOUS | 103964 | HOFFMAN-LA ROCHE | 03/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39 |
| Pegintron | Peginterferon Alfa-2b | SYRINGE | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27 |
| Pegintron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27 |
| Pegintron | Peginterferon Alfa-2b | SYRINGE | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13 |
| Pegintron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13 |
| Pegintron | Peginterferon Alfa-2b | SYRINGE | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29 |
| Pegintron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29 |
| Pennsaid | Diclofenac Sodium | SOLUTION;TOPICAL | 020947 | NUVO PHARMS INC | 05/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf |
| Percocet | Acetaminophen; Oxycodone Hydrochloride | TABLET;ORAL | 040330 | VINTAGE PHARMS LLC | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/040330s052lbl.pdf |
| Percodan | Aspirin; Oxycodone Hydrochloride | TABLET;ORAL | 007337 | ENDO PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf#page=26 |
| Percodan | Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | TABLET;ORAL | 007337 | ENDO PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf#page=26 |
| Percodan-Demi | Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | TABLET;ORAL | 007337 | ENDO PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf#page=26 |
| Perforomist | Formoterol Fumarate | SOLUTION;INHALATION | 022007 | MYLAN SPECLT | 05/29/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214444.pdf |
| Perforomist | Formoterol Fumarate | SOLUTION;INHALATION | 022007 | MYLAN SPECLT | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf#page=19 |
| Pertzye | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022175 | DIGESTIVE CARE INC | 03/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf#page=13 |
| Pexeva | Paroxetine Mesylate | TABLET;ORAL | 021299 | SEBELA IRELAND LTD | 12/31/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf#page=38 |
| Phenergan VC W/ Codeine | Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | SYRUP;ORAL | 008306 | ANI PHARMS | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29 |
| Phenergan W/ Codeine | Codeine Phosphate; Promethazine Hydrochloride | SYRUP;ORAL | 008306 | ANI PHARMS | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29 |
| Plavix | Clopidogrel Bisulfate | TABLET;ORAL | 020839 | SANOFI AVENTIS US | 03/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf#page=23 |
| Plavix | Clopidogrel Bisulfate | TABLET;ORAL | 020839 | SANOFI AVENTIS US | 03/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020839s072lbl.pdf#page=24 |
| Plavix | Clopidogrel Bisulfate | TABLET;ORAL | 020839 | SANOFI AVENTIS US | 03/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/ 020839s074lbl.pdf#page=24 |
| Plegridy | Peginterferon Beta-1a | INJECTABLE;INJECTION | 125499 | BIOGEN IDEC INC | 01/29/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM475804.pdf |
| Plegridy | Peginterferon Beta-1a | INJECTABLE;INJECTION | 125499 | BIOGEN IDEC INC | 01/29/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125499s018lbl.pdf#page=19 |
| Plegridy | Peginterferon Beta-1a | INJECTABLE;INJECTION | 125499 | BIOGEN IDEC INC | 01/29/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s021lbl.pdf#page=20 |
| Plenvu | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | FOR SOLUTION;ORAL | 209381 | SALIX | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf#page=17 |
| Plenvu | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | FOR SOLUTION;ORAL | 209381 | SALIX | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s001lbl.pdf#page=17 |
| Plenvu | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | FOR SOLUTION;ORAL | 209381 | SALIX | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s002lbl.pdf#page=17 |
| Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 12/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf#page=31 |
| Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 12/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf#page=31 |
| Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 12/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s023lbl.pdf#page=33 |
| Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 12/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s024lbl.pdf#page=33 |
| Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 12/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf#page=33 |
| Ponstel | Mefenamic Acid | CAPSULE;ORAL | 015034 | AVION PHARMS | 05/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088692.pdf |
| Ponvory | Ponesimod | TABLET;ORAL | 213498 | JANSSEN PHARMS | 03/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s000lbl.pdf#page=30 |
| Potiga | Ezogabine | TABLET;ORAL | 022345 | GLAXOSMITHKLINE | 05/20/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf |
| Pradaxa | Dabigatran Etexilate Mesylate | CAPSULE;ORAL | 022512 | BOEHRINGER INGELHEIM | 07/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022512s039lbl.pdf#page=24 |
| Prepopik | Citric Acid; Magnesium Oxide; Sodium Picosulfate | FOR SOLUTION;ORAL | 202535 | FERRING PHARMS INC | 08/15/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf#page=15 |
| Pretomanid | Pretomanid | TABLET;ORAL | 212862 | MYLAN IRELAND LTD | 08/14/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212862s000lbl.pdf#page=19 |
| Prevacid | Lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 020406 | TAKEDA PHARMS USA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf#page=44 |
| Prevacid | Lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428 | TAKEDA PHARMS USA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38 |
| Prevacid | Lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428 | TAKEDA PHARMS USA | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf#page=44 |
| Prevacid Naprapac 250 (Copackaged) | Lansoprazole; Naproxen | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 021507 | TAKEDA PHARMS NA | 07/31/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf |
| Prevacid Naprapac 375 (Copackaged) | Lansoprazole; Naproxen | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 021507 | TAKEDA PHARMS NA | 07/31/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf |
| Prevacid Naprapac 500 (Copackaged) | Lansoprazole; Naproxen | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | 021507 | TAKEDA PHARMS NA | 07/31/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf |
| Priftin | Rifapentine | TABLET;ORAL | 021024 | SANOFI AVENTIS US | 06/09/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426514.pdf |
| Priftin | Rifapentine | TABLET;ORAL | 021024 | SANOFI AVENTIS US | 06/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf#page=28 |
| Prilosec | Omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810 | ASTRAZENECA | 12/19/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf |
| Prilosec | Omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810 | ASTRAZENECA | 12/19/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf#page=34 |
| Prilosec | Omeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056 | COVIS | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf#page=34 |
| Prilosec | Omeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056 | COVIS | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022056s023lbl.pdf#page=35 |
| Pristiq | Desvenlafaxine Succinate | TABLET, EXTENDED RELEASE;ORAL | 021992 | PF PRISM CV | 02/06/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf#page=35 |
| Probuphine | Buprenorphine Hydrochloride | IMPLANT;IMPLANTATION | 204442 | TITAN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204442s009lbl.pdf#page=49 |
| Prohance | Gadoteridol | INJECTABLE;INJECTION | 020131 | BRACCO | 12/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020131s035lbl.pdf#page16 |
| Prohance Multipack | Gadoteridol | INJECTABLE;INJECTION | 021489 | BRACCO | 12/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf#page=16 |
| Prolia | Denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | AMGEN | 06/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdf#page=30 |
| Prolia | Denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | AMGEN | 06/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s205lbl.pdf#page=30 |
| Promacta | Eltrombopag Olamine | TABLET;ORAL | 022291 | NOVARTIS | 02/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s021lbl.pdf#page=35 |
| Promacta | Eltrombopag Olamine | TABLET;ORAL | 022291 | NOVARTIS | 02/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf#page=35 |
| Promacta Kit | Eltrombopag Olamine | FOR SUSPENSION;ORAL | 207027 | NOVARTIS | 02/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207027s008lbl.pdf#page=35 |
| Promacta Kit | Eltrombopag Olamine | FOR SUSPENSION;ORAL | 207027 | NOVARTIS | 02/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf#page=35 |
| Promacta Kit | Eltrombopag Olamine | FOR SUSPENSION;ORAL | 207027 | NOVARTIS | 02/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207027s014lbl.pdf#page=35 |
| Propulsid | Cisapride Monohydrate | TABLET;ORAL | 020210 | JANSSEN PHARMS | 03/06/2000 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Propulsid.pdf |
| Propylthiouracil | Propylthiouracil | TABLET;ORAL | 006188 | DAVA PHARMS INC | 09/19/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf#page=7 |
| Proquin XR | Ciprofloxacin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021744 | DEPOMED INC | 08/15/2011 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Proquin XR.pdf |
| Protonix | Pantoprazole Sodium | TABLET, DELAYED RELEASE;ORAL | 020987 | WYETH PHARMS | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf#page=33 |
| Protonix | Pantoprazole Sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020 | WYETH PHARMS | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf#page=33 |
| Protopic | Tacrolimus | OINTMENT;TOPICAL | 050777 | LEO PHARMA AS | 02/25/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088996.pdf |
| Provigil | Modafinil | TABLET;ORAL | 020717 | CEPHALON | 01/15/2015 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf |
| Prozac | Fluoxetine Hydrochloride | CAPSULE;ORAL | 018936 | ELI LILLY AND CO | 04/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf#page=26 |
| Prozac Weekly | Fluoxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021235 | LILLY | 03/24/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28 |
| Qdolo | Tramadol Hydrochloride | SOLUTION;ORAL | 214044 | ATHENA | 09/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214044s000lbl.pdf#page=27 |
| Qelbree | Viloxazine Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964 | SUPERNUS PHARMS | 04/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf#page=18 |
| Qmiiz ODT | Meloxicam | TABLET, ORALLY DISINTEGRATING;ORAL | 211210 | TERSERA | 08/20/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211210s000lbl.pdf#page=35 |
| Qsymia | Phentermine Hydrochloride; Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580 | VIVUS | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf#page=37 |
| Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 01/24/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s003lbl.pdf#page=37 |
| Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s000lbl.pdf |
| Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s002lbl.pdf#page=40 |
| Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s004lbl.pdf#page=40 |
| Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209091s005lbl.pdf#page=37 |
| Qternmet XR | Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf#page=50 |
| Qternmet XR | Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s001lbl.pdf#page=50 |
| Qternmet XR | Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210874s003lbl.pdf#page=47 |
| Qualaquin | Quinine Sulfate | CAPSULE;ORAL | 021799 | SUN PHARM INDUSTRIES | 06/19/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM192698.pdf |
| Qualaquin | Quinine Sulfate | CAPSULE;ORAL | 021799 | SUN PHARM INDUSTRIES | 06/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021799s029lbl.pdf#page=26 |
| Qudexy XR | Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122 | UPSHER SMITH LABS | 02/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf#page=69 |
| Qudexy XR | Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122 | UPSHER SMITH LABS | 02/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205122s008lbl.pdf#page=59 |
| Qudexy XR | Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122 | UPSHER SMITH LABS | 02/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205122s010lbl.pdf#page=60 |
| Quillichew ER | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960 | NEXTWAVE PHARMS | 02/28/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf#page=13 |
| Quillivant XR | Methylphenidate Hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NEXTWAVE | 01/24/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf#page=14 |
| Rapamune | Sirolimus | SOLUTION;ORAL | 021083 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf#page=41 |
| Rapamune | Sirolimus | SOLUTION;ORAL | 021083 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s064,021110s083lbl.pdf#page=43 |
| Rapamune | Sirolimus | SOLUTION;ORAL | 021083 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s065,021110s084lbl.pdf#page=41 |
| Rapamune | Sirolimus | SOLUTION;ORAL | 021083 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf#page=43 |
| Rapamune | Sirolimus | TABLET;ORAL | 021110 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf#page=41 |
| Rapamune | Sirolimus | TABLET;ORAL | 021110 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s064,021110s083lbl.pdf#page=43 |
| Rapamune | Sirolimus | TABLET;ORAL | 021110 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s065,021110s084lbl.pdf#page=41 |
| Rapamune | Sirolimus | TABLET;ORAL | 021110 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf#page=43 |
| Ravicti | Glycerol Phenylbutyrate | LIQUID;ORAL | 203284 | HORIZON THERAP | 10/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf#page=1 |
| Ravicti | Glycerol Phenylbutyrate | LIQUID;ORAL | 203284 | HORIZON THERAP | 10/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203284s010lbl.pdf#page=27 |
| Ravicti | Glycerol Phenylbutyrate | LIQUID;ORAL | 203284 | HORIZON THERAP | 10/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203284s011lbl.pdf#page=27 |
| Rebetol | Ribavirin | CAPSULE;ORAL | 020903 | MERCK SHARP DOHME | 01/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf#page=26 |
| Rebetol | Ribavirin | SOLUTION;ORAL | 021546 | SCHERING | 01/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf#page=26 |
| Rebif | Interferon Beta-1a | SYRINGE | 103780 | SERONO INC | 05/26/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089019.pdf |
| Rebif | Interferon Beta-1a | SYRINGE | 103780 | SERONO INC | 05/26/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf#page=16 |
| Reclast | Zoledronic Acid | INJECTABLE;INTRAVENOUS | 021817 | NOVARTIS | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf#page=25 |
| Reclast | Zoledronic Acid | INJECTABLE;INTRAVENOUS | 021817 | NOVARTIS | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021817s028lbl.pdf#page=25 |
| Reglan | Metoclopramide Hydrochloride | TABLET;ORAL | 017854 | ANI PHARMS | 08/29/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf |
| Reglan | Metoclopramide Hydrochloride | INJECTABLE;INJECTION | 017862 | WEST-WARD PHARMS INT | 11/18/2010 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf |
| Reglan ODT | Metoclopramide Hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793 | MEDA PHARMS | 11/30/2011 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf |
| Regranex | Becaplermin | GEL; TOPICAL | 103691 | SMITH AND NEPHEW | 08/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103691s5134lbl.pdf#page=11 |
| Regranex | Becaplermin | GEL; TOPICAL | 103691 | SMITH AND NEPHEW | 08/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf#page=8 |
| Relistor | Methylnaltrexone Bromide | SOLUTION;SUBCUTANEOUS | 021964 | SALIX PHARMS | 03/14/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf#page=24 |
| Relistor | Methylnaltrexone Bromide | TABLET;ORAL | 208271 | SALIX | 03/14/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf#page=24 |
| Remeron | Mirtazapine | TABLET;ORAL | 020415 | ORGANON USA INC | 04/29/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026mg.pdf |
| Remeron | Mirtazapine | TABLET;ORAL | 020415 | ORGANON USA INC | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf#page=24 |
| Remeron | Mirtazapine | TABLET;ORAL | 020415 | ORGANON USA INC | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf#page=23 |
| Remeron Soltab | Mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | ORGANON USA INC | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf#page=24 |
| Remeron Soltab | Mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | ORGANON USA INC | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021208s025lbl.pdf#page=24 |
| Remeron Soltab | Mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | ORGANON USA INC | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf#page=23 |
| Remicade | Infliximab | VIAL | 103772 | CENTOCOR INC | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf#page=48 |
| Remicade | Infliximab | VIAL | 103772 | CENTOCOR INC | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf#page=50 |
| Renflexis | Infliximab-Abda | INJECTABLE;INJECTION | 761054 | SAMSUNG BIOEPIS CO LTD | 06/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054lbl.pdf#page=51 |
| Renflexis | Infliximab-Abda | INJECTABLE;INJECTION | 761054 | SAMSUNG BIOEPIS CO LTD | 06/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf#page=52 |
| Renflexis | Infliximab-Abda | INJECTABLE;INJECTION | 761054 | SAMSUNG BIOEPIS CO LTD | 06/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf#page=52 |
| Restoril | Temazepam | CAPSULE;ORAL | 018163 | SPECGX LLC | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018163s067lbl.pdf#page=16 |
| Retacrit | Epoetin Alfa-Epbx | INJECTABLE;INJECTION | 125545 | HOSPIRA INC | 06/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf#page=28 |
| Retacrit | Epoetin Alfa-Epbx | INJECTABLE;INJECTION | 125545 | HOSPIRA INC | 06/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf#page=28 |
| Retacrit | Epoetin Alfa-Epbx | INJECTABLE;INJECTION | 125545 | HOSPIRA INC | 06/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf#page=31 |
| Revlimid | Lenalidomide | CAPSULE;ORAL | 021880 | CELGENE | 09/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf#page=42 |
| Revlimid | Lenalidomide | CAPSULE;ORAL | 021880 | CELGENE | 09/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s056lbl.pdf#page=42 |
| Revlimid | Lenalidomide | CAPSULE;ORAL | 021880 | CELGENE | 09/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s057lbl.pdf#page=49 |
| Revlimid | Lenalidomide | CAPSULE;ORAL | 021880 | CELGENE | 09/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s060lbl.pdf#page=49 |
| Rexulti | Brexpiprazole | TABLET;ORAL | 205422 | OTSUKA | 06/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf#page=36 |
| Rexulti | Brexpiprazole | TABLET;ORAL | 205422 | OTSUKA | 06/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf#page=27 |
| Reyvow | Lasmiditan Succinate | TABLET;ORAL | 211280 | ELI LILLY AND CO | 07/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211280s001lbl.pdf#page=14 |
| Rezira | Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | SOLUTION;ORAL | 022442 | PERSION | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf#page=26 |
| Riabni | Rituximab-Arrx | INJECTABLE;INJECTION | 761140 | AMGEN INC | 12/17/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761140s000lbl.pdf#page=31 |
| Ribasphere | Ribavirin | CAPSULE;ORAL | 076203 | CHARTWELL RX | 05/31/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111342.pdf |
| Rinvoq | Upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675 | ABBVIE INC | 07/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf#page=28 |
| Rinvoq | Upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675 | ABBVIE INC | 07/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf#page=29 |
| Ritalin | Methylphenidate Hydrochloride | TABLET;ORAL | 010187 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf#page=14 |
| Ritalin | Methylphenidate Hydrochloride | TABLET;ORAL | 010187 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf#page=13 |
| Ritalin LA | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284 | NOVARTIS | 11/19/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021284s034lbl.pdf#page=18 |
| Ritalin LA | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021284s016s029lbl.pdf#page=17 |
| Ritalin LA | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021284s041lbl.pdf#page=16 |
| Ritalin-SR | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 018029 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf#page=14 |
| Ritalin-SR | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 018029 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf#page=13 |
| Rituxan | Rituximab | SOLUTION;INTRAVENOUS | 103705 | GENENTECH | 08/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf#page=46 |
| Rituxan Hycela | Rituximab; Hyaluronidase (Human Recombinant) | SOLUTION;SUBCUTANEOUS | 761064 | GENENTECH INC | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf#page=29 |
| Rituxan Hycela | Rituximab; Hyaluronidase (Human Recombinant) | SOLUTION;SUBCUTANEOUS | 761064 | GENENTECH INC | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761064s009lbl.pdf#page=26 |
| Rituxan Hycela | Rituximab; Hyaluronidase (Human Recombinant) | SOLUTION;SUBCUTANEOUS | 761064 | GENENTECH INC | 05/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf#page=28 |
| Roxicodone | Oxycodone Hydrochloride | TABLET;ORAL | 021011 | SPECGX LLC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021011s011lbl.pdf#page=30 |
| Roxybond | Oxycodone Hydrochloride | TABLET;ORAL | 209777 | OHEMO LIFE | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf#page=43 |
| Roxybond | Oxycodone Hydrochloride | TABLET;ORAL | 209777 | OHEMO LIFE | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf#page=39 |
| Rozerem | Ramelteon | TABLET;ORAL | 021782 | TAKEDA PHARMS USA | 12/21/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011Medguide.pdf |
| Rozerem | Ramelteon | TABLET;ORAL | 021782 | TAKEDA PHARMS USA | 12/21/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021782s021lbl.pdf#page=16 |
| Ruxience | Rituximab-Pvvr | INJECTABLE;INJECTION | 761103 | PFIZER INC | 05/26/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf#page=31 |
| Ruxience | Rituximab-Pvvr | INJECTABLE;INJECTION | 761103 | PFIZER INC | 05/26/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf#page=32 |
| Ruzurgi | Amifampridine | TABLET;ORAL | 209321 | JACOBUS PHARM CO INC | 08/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf#page=15 |
| Rybelsus | Semaglutide | TABLET;ORAL | 213051 | NOVO | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf#page=24 |
| Rybelsus | Semaglutide | TABLET;ORAL | 213051 | NOVO | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23 |
| Rybelsus | Semaglutide | TABLET;ORAL | 213182 | NOVO NORDISK INC | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23 |
| Sabril | Vigabatrin | TABLET;ORAL | 020427 | LUNDBECK PHARMS LLC | 10/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26 |
| Sabril | Vigabatrin | TABLET;ORAL | 020427 | LUNDBECK PHARMS LLC | 10/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf#page=26 |
| Sabril | Vigabatrin | FOR SOLUTION;ORAL | 022006 | LUNDBECK PHARMS LLC | 10/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26 |
| Sabril | Vigabatrin | FOR SOLUTION;ORAL | 022006 | LUNDBECK PHARMS LLC | 10/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf#page=26 |
| Samsca | Tolvaptan | TABLET;ORAL | 022275 | OTSUKA | 04/23/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbl.pdf#page=24 |
| Sarafem | Fluoxetine Hydrochloride | CAPSULE;ORAL | 018936 | ELI LILLY AND CO | 04/28/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf#page=26 |
| Sarafem | Fluoxetine Hydrochloride | TABLET;ORAL | 021860 | APIL | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf#page=33 |
| Sarafem | Fluoxetine Hydrochloride | TABLET;ORAL | 021860 | APIL | 01/04/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089119.pdf |
| Savaysa | Edoxaban Tosylate | TABLET;ORAL | 206316 | DAIICHI SANKYO INC | 04/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf#page=32 |
| Savaysa | Edoxaban Tosylate | TABLET;ORAL | 206316 | DAIICHI SANKYO INC | 04/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206316s015lbl.pdf#page=34 |
| Savaysa | Edoxaban Tosylate | TABLET;ORAL | 206316 | DAIICHI SANKYO INC | 04/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf#page=35 |
| Savella | Milnacipran Hydrochloride | TABLET;ORAL | 022256 | ALLERGAN | 12/19/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf#page=30 |
| Saxenda | Liraglutide Recombinant | SOLUTION;SUBCUTANEOUS | 206321 | NOVO | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf#page=26 |
| Saxenda | Liraglutide Recombinant | SOLUTION;SUBCUTANEOUS | 206321 | NOVO | 12/04/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s011lbl.pdf#page=26 |
| Segluromet | Ertugliflozin; METformin Hydrochloride | TABLET;ORAL | 209806 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209806s001lbl.pdf#page=32 |
| Segluromet | Ertugliflozin; METformin Hydrochloride | TABLET;ORAL | 209806 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209806s002lbl.pdf#page=32 |
| Selzentry | Maraviroc | TABLET;ORAL | 022128 | VIIV HLTHCARE | 10/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43 |
| Selzentry | Maraviroc | TABLET;ORAL | 022128 | VIIV HLTHCARE | 10/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43 |
| Selzentry | Maraviroc | SOLUTION;ORAL | 208984 | VIIV HLTHCARE | 10/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43 |
| Serevent | Salmeterol Xinafoate | POWDER;INHALATION | 020692 | GLAXOSMITHKLINE | 07/22/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf |
| Serevent | Salmeterol Xinafoate | POWDER;INHALATION | 020692 | GLAXOSMITHKLINE | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020692s046lbl.pdf#page=34 |
| Serevent | Salmeterol Xinafoate | POWDER;INHALATION | 020692 | GLAXOSMITHKLINE | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf#page=35 |
| Seroquel | Quetiapine Fumarate | TABLET;ORAL | 020639 | ASTRAZENECA | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s070lbl.pdf#page=49 |
| Seroquel XR | Quetiapine Fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047 | ASTRAZENECA | 09/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047s041s044lbl.pdf#page=52 |
| Signifor | Pasireotide Diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | RECORDATI RARE | 01/15/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM332633.pdf |
| Signifor | Pasireotide Diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | RECORDATI RARE | 01/15/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s005lbl.pdf#page=16 |
| Signifor | Pasireotide Diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | RECORDATI RARE | 01/15/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200677s006lbl.pdf#page=15 |
| Signifor LAr Kit | Pasireotide Pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | RECORDATI RARE | 07/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf#page=27 |
| Siklos | Hydroxyurea | TABLET;ORAL | 208843 | ADDMEDICA SAS | 05/22/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208843s002lbl.pdf#page=17 |
| Siklos | Hydroxyurea | TABLET;ORAL | 208843 | ADDMEDICA SAS | 05/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf#page=17 |
| Silenor | Doxepin Hydrochloride | TABLET;ORAL | 022036 | CURRAX | 10/29/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206668.pdf |
| Siliq | Brodalumab | INJECTABLE;INJECTION | 761032 | VALEANT LUXEMBOURG | 01/22/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf#page=13 |
| Simponi | Golimumab | INJECTABLE; INJECTION | 125289 | CENTOCOR ORTHO BIOTECH INC | 09/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf#page=38 |
| Simponi Aria | Golimumab | INJECTABLE; INJECTION | 125433 | JANSSEN BIOTECH | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf#page=28 |
| Simponi Aria | Golimumab | INJECTABLE; INJECTION | 125433 | JANSSEN BIOTECH | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125433s028lbl.pdf#page=31 |
| Simponi Aria | Golimumab | INJECTABLE; INJECTION | 125433 | JANSSEN BIOTECH | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125433s030s031lbl.pdf#page=34 |
| Simponi Aria | Golimumab | INJECTABLE; INJECTION | 125433 | JANSSEN BIOTECH | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf#page=34 |
| Sinequan | Doxepin Hydrochloride | CAPSULE;ORAL | 016798 | PFIZER | 07/14/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089129.pdf |
| Singulair | Montelukast Sodium | TABLET;ORAL | 020829 | MSD MERCK CO | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s076,021409s052lbl.pdf#page=25 |
| Singulair | Montelukast Sodium | TABLET, CHEWABLE;ORAL | 020830 | MSD MERCK CO | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25 |
| Singulair | Montelukast Sodium | GRANULE;ORAL | 021409 | MERCK | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020829s073,020830s075,021409s051lbl.pdf#page=22 |
| Singulair | Montelukast Sodium | GRANULE;ORAL | 021409 | MERCK | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25 |
| Sirturo | Bedaquiline Fumarate | TABLET;ORAL | 204384 | JANSSEN THERAP | 05/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204384s011lbl.pdf#page=24 |
| Sirturo | Bedaquiline Fumarate | TABLET;ORAL | 204384 | JANSSEN THERAP | 05/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204384s014lbl.pdf#page=24 |
| Skyrizi | Risankizumab-Rzaa | INJECTABLE;INJECTION | 761105 | ABBVIE INC | 03/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf#page=12 |
| Skyrizi | Risankizumab-Rzaa | INJECTABLE;INJECTION | 761105 | ABBVIE INC | 03/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf#page=13 |
| Sodium Oxybate | Sodium Oxybate | SOLUTION;ORAL | 202090 | HIKMA | 01/17/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18 |
| Solaraze | Diclofenac Sodium | GEL;TOPICAL | 021005 | FOUGERA PHARMS | 05/16/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf |
| Soliqua 100/33 | Insulin Glargine; Lixisenatide | SOLUTION;SUBCUTANEOUS | 208673 | SANOFI-AVENTIS US | 11/15/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf#page=37 |
| Soliqua 100/33 | Insulin Glargine; Lixisenatide | SOLUTION;SUBCUTANEOUS | 208673 | SANOFI-AVENTIS US | 11/15/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s007lbl.pdf#page=29 |
| Soliqua 100/33 | Insulin Glargine; Lixisenatide | SOLUTION;SUBCUTANEOUS | 208673 | SANOFI-AVENTIS US | 11/15/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf#page=30 |
| Soliris | Eculizumab | INJECTABLE; IV (INFUSION) | 125166 | ALEXION PHARM | 11/20/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166Orig1s427s428MedGuide.pdf |
| Soliris | Eculizumab | INJECTABLE; IV (INFUSION) | 125166 | ALEXION PHARM | 11/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf#page=40 |
| Soltamox | Tamoxifen Citrate | SOLUTION;ORAL | 021807 | MAYNE PHARMA INC | 04/08/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lblMG.pdf |
| Soltamox | Tamoxifen Citrate | SOLUTION;ORAL | 021807 | MAYNE PHARMA INC | 04/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf#page=36 |
| Soltamox | Tamoxifen Citrate | SOLUTION;ORAL | 021807 | MAYNE PHARMA INC | 04/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf#page=36 |
| Sonata | Zaleplon | CAPSULE;ORAL | 020859 | PFIZER | 08/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM349707.pdf |
| Sonata | Zaleplon | CAPSULE;ORAL | 020859 | PFIZER | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s015lbl.pdf#page=21 |
| Sonata | Zaleplon | CAPSULE;ORAL | 020859 | PFIZER | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf#page=21 |
| Soriatane | Acitretin | CAPSULE;ORAL | 019821 | STIEFEL LABS INC | 09/27/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018mg.pdf |
| Sotret | Isotretinoin | CAPSULE;ORAL | 076041 | SUN PHARM INDS LTD | 04/12/2012 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Sotret.pdf |
| Spravato | Esketamine Hydrochloride | SPRAY;NASAL | 211243 | JANSSEN PHARMS | 07/31/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf#page=42 |
| Spritam | Levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958 | APRECIA PHARMS | 01/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf#page=36 |
| Spritam | Levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958 | APRECIA PHARMS | 01/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf#page=34 |
| Spritam | Levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958 | APRECIA PHARMS | 01/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207958s019lbl.pdf#page=36 |
| Sprix | Ketorolac Tromethamine | SPRAY, METERED;NASAL | 022382 | ZYLA | 01/22/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf#page=20 |
| Steglatro | Ertugliflozin | TABLET;ORAL | 209803 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf#page=24 |
| Steglatro | Ertugliflozin | TABLET;ORAL | 209803 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf#page=25 |
| Steglatro | Ertugliflozin | TABLET;ORAL | 209803 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209803s002lbl.pdf#page=25 |
| Steglujan | Ertugliflozin; Sitagliptin Phosphate | TABLET;ORAL | 209805 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf#page=32 |
| Steglujan | Ertugliflozin; Sitagliptin Phosphate | TABLET;ORAL | 209805 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf#page=32 |
| Steglujan | Ertugliflozin; Sitagliptin Phosphate | TABLET;ORAL | 209805 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209805s005lbl.pdf#page=32 |
| Steglujan | Ertugliflozin; Sitagliptin Phosphate | TABLET;ORAL | 209805 | MERCK SHARP DOHME | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209805s006lbl.pdf#page=32 |
| Stelara | Ustekinumab | INJECTABLE; INJECTION | 125261 | CENTOCOR ORTHO BIOTECH INC | 12/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf#page=36 |
| Stelara | Ustekinumab | INJECTABLE;INJECTION | 761044 | JANSSEN BIOTECH | 12/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf#page=36 |
| Stelara | Ustekinumab | INJECTABLE;INJECTION | 761044 | JANSSEN BIOTECH | 12/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761044s008lbl.pdf#page=36 |
| Strattera | Atomoxetine Hydrochloride | CAPSULE;ORAL | 021411 | LILLY | 02/25/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf#page=19 |
| Strattera | Atomoxetine Hydrochloride | CAPSULE;ORAL | 021411 | LILLY | 02/25/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021411s049lbl.pdf#page=21 |
| Striverdi Respimat | Olodaterol Hydrochloride | SPRAY, METERED;INHALATION | 203108 | BOEHRINGER INGELHEIM | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/striverdi respimatMedGuide2016.pdf |
| Sublocade | Buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 209819 | INDIVIOR INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s017s018lbl.pdf#page=43 |
| Suboxone | Buprenorphine Hydrochloride; Naloxone Hydrochloride | TABLET;SUBLINGUAL | 020733 | INDIVIOR INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024lbl.pdf#page=30 |
| Suboxone | Buprenorphine Hydrochloride; Naloxone Hydrochloride | TABLET;SUBLINGUAL | 020733 | INDIVIOR INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020733s028lbl.pdf#page=32 |
| Suboxone | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410 | INDIVIOR INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32 |
| Suboxone | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410 | INDIVIOR INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022410s042lbl.pdf#page=34 |
| Subsys | Fentanyl | SPRAY;SUBLINGUAL | 202788 | BTCP PHARMA | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf#page=38 |
| Subsys | Fentanyl | SPRAY;SUBLINGUAL | 202788 | BTCP PHARMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf#page=38 |
| Subsys | Fentanyl | SPRAY;SUBLINGUAL | 202788 | BTCP PHARMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf#page=40 |
| Subutex | Buprenorphine Hydrochloride | TABLET;SUBLINGUAL | 020732 | INDIVIOR INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020732s024lbl.pdf#page=29 |
| Suclear | Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Potassium Sulfate; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate | SOLUTION;ORAL | 203595 | BRAINTREE LABS | 08/15/2013 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337734.pdf |
| Sunosi | Solriamfetol Hydrochloride | TABLET;ORAL | 211230 | JAZZ | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230_Orig1Orig2s000lbl.pdf#page=23 |
| Supprelin LA | Histrelin Acetate | IMPLANT;SUBCUTANEOUS | 022058 | ENDO PHARM | 11/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf#page=19 |
| Supprelin LA | Histrelin Acetate | IMPLANT;SUBCUTANEOUS | 022058 | ENDO PHARM | 11/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022058s016lbl.pdf#page=20 |
| Suprep Bowel Prep Kit | Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate | SOLUTION;ORAL | 022372 | BRAINTREE LABS | 08/05/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000MedGuide.pdf |
| Suprep Bowel Prep Kit | Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate | SOLUTION;ORAL | 022372 | BRAINTREE LABS | 08/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022372s013lbl.pdf#page=13 |
| Surmontil | Trimipramine Maleate | CAPSULE;ORAL | 016792 | ODYSSEY PHARMS | 09/30/2014 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf#page=12 |
| Sustol | Granisetron | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 022445 | HERON THERAPS INC | 08/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524796.pdf |
| Sutab (Copackaged) | Magnesium Sulfate; Potassium Chloride; Sodium Sulfate | TABLET;ORAL | 213135 | BRAINTREE LABS | 11/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213135s000lbl.pdf#page=14 |
| Sutent | Sunitinib Malate | CAPSULE;ORAL | 021938 | CPPI CV | 08/14/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM219111.pdf |
| Sutent | Sunitinib Malate | CAPSULE;ORAL | 021938 | CPPI CV | 08/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021938s036lbl.pdf#page=35 |
| Sutent | Sunitinib Malate | CAPSULE;ORAL | 021938 | CPPI CV | 08/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s037lbl.pdf#page=33 |
| Sutent | Sunitinib Malate | CAPSULE;ORAL | 021938 | CPPI CV | 08/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021938s038lbl.pdf#page=35 |
| Sylatron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27 |
| Sylatron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13 |
| Sylatron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 01/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29 |
| Symbyax | Fluoxetine Hydrochloride; Olanzapine | CAPSULE;ORAL | 021520 | LILLY | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s052lbl.pdf#page=42 |
| Symlin | Pramlintide Acetate | INJECTABLE;SUBCUTANEOUS | 021332 | ASTRAZENECA AB | 12/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf |
| Sympazan | Clobazam | FILM;ORAL | 210833 | AQUESTIVE | 03/16/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210833s000lbl.pdf#page=26 |
| Sympazan | Clobazam | FILM;ORAL | 210833 | AQUESTIVE | 03/16/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s002lbl.pdf#page=27 |
| Symproic | Naldemedine Tosylate | TABLET;ORAL | 208854 | BDSI | 01/24/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf#page=13 |
| Synalgos-DC | Aspirin; Caffeine; Dihydrocodeine Bitartrate | CAPSULE;ORAL | 011483 | SUN PHARM INDUSTRIES | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011483s033lbl.pdf#page=28 |
| Synarel | Nafarelin Acetate | SPRAY, METERED;NASAL | 019886 | PFIZER | 05/19/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf#page=28 |