Medication Guides

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 | 11/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021436s048lbl.pdf#page=47 |
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/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/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 | 11/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207202s006lbl.pdf#page=64 |
Abrilada | Adalimumab-Afzb | INJECTABLE;INJECTION | 761118 | PFIZER INC | 07/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761118s006lbl.pdf#page=44 |
Absorica | Isotretinoin | CAPSULE;ORAL | 021951 | SUN PHARM INDS INC | 10/08/2021 | 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 | WOODWARD | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020973s042lbl.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 | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s134lbl.pdf#page=50 |
Actemra | Tocilizumab | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 125472 | GENENTECH | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s046lbl.pdf#page=50 |
Acthar Gel | Corticotropin | INJECTABLE;INJECTION | 008372 | MALLINCKRODT ARD | 10/29/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s071lbl.pdf#page=17 |
Actiq | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747 | CEPHALON | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020747s056lbl.pdf#page=43 |
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;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 | 02/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf#page=28 |
Adderall 10 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 12.5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 15 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 20 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 30 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 7.5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall XR 10 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021303s036lbl.pdf#page=23 |
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 | 04/11/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf#page=23 |
Adempas | Riociguat | TABLET;ORAL | 204819 | BAYER HLTHCARE | 09/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204819s015lbl.pdf#page=24 |
Adhansia XR | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212038 | PURDUE PHARMA LP | 06/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf#page=25 |
Adlyxin | Lixisenatide | SOLUTION;SUBCUTANEOUS | 208471 | SANOFI-AVENTIS US | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf#page=24 |
Adzenys ER | Amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325 | NEOS THERAPS INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204325s003lbl.pdf#page=26 |
Adzenys XR-Odt | Amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326 | NEOS THERAPS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf#page=26 |
Afrezza | Insulin Recombinant Human | POWDER;INHALATION | 022472 | MANNKIND | 10/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf#page=12 |
Alkindi Sprinkle | Hydrocortisone | GRANULE;ORAL | 213876 | ETON | 12/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213876s002lbl.pdf#page=14 |
Ambien | Zolpidem Tartrate | TABLET;ORAL | 019908 | SANOFI AVENTIS US | 02/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf#page=24 |
Ambien CR | Zolpidem Tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774 | SANOFI AVENTIS US | 02/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf#page=27 |
Amjevita | Adalimumab-Atto | INJECTABLE;INJECTION | 761024 | AMGEN INC | 07/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf#page=46 |
Ampyra | Dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250 | ACORDA | 11/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s019lbl.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 | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf#page=23 |
Anaprox DS | Naproxen Sodium | TABLET;ORAL | 018164 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.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 | 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 | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022108s022lbl.pdf#page=29 |
Aptensio XR | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205831 | RHODES PHARMS | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205831s006lbl.pdf#page=17 |
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 | 07/30/2021 | 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/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 | 08/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020607s040lbl.pdf#page33 |
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 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf#page=91 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 050709 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf#page=91 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 050708 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf#page=91 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 210115 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210115s006lbl.pdf#page=33 |
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 | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017794s049lbl.pdf#page=14 |
Aubagio | Teriflunomide | TABLET;ORAL | 202992 | SANOFI AVENTIS US | 04/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf#page=25 |
Austedo | Deutetrabenazine | TABLET;ORAL | 208082 | TEVA BRANDED PHARM | 05/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208082s011lbl.pdf#page=25 |
Auvelity | Bupropion; Dextromethorphan | TABLET, EXTENDED RELEASE; ORAL | 215430 | AXSOME INC | 08/18/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215430s000lblCorrect3.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 | WOODWARD | 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 | 08/16/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf#page=23 |
Avelox | Moxifloxacin Hydrochloride | TABLET;ORAL | 021085 | BAYER HLTHCARE | 07/26/2016 | 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 | 09/27/2016 | 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 | 11/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103628s5266lbl.pdf#page=22 |
Avsola | Infliximab-Axxq | INJECTABLE;INJECTION | 761086 | AMGEN INC | 09/09/2021 | 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 | Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride | CAPSULE;ORAL | 212994 | COMMAVE THERAP | 03/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212994s000lbl.pdf#page=26 |
Banzel | Rufinamide | SUSPENSION;ORAL | 201367 | EISAI INC | 11/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19 |
Banzel | Rufinamide | TABLET;ORAL | 021911 | EISAI INC | 11/28/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19 |
Bavencio | Avelumab | INJECTABLE;INTRAVENOUS | 761078 | EMD SERONO INC | 05/09/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf#page=23 |
Bavencio | Avelumab | INJECTABLE;INJECTION | 761049 | EMD SERONO INC | 07/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf#page=36 |
Baxdela | Delafloxacin Meglumine | TABLET;ORAL | 208610 | MELINTA | 06/19/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28 |
Baxdela | Delafloxacin Meglumine | POWDER;INTRAVENOUS | 208611 | MELINTA | 06/19/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28 |
Belbuca | Buprenorphine Hydrochloride | FILM;BUCCAL | 207932 | BDSI | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf#page=38 |
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 | 761043 | GLAXOSMITHKLINE LLC | 07/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761043s021lbl.pdf#page=41 |
Benlysta | Belimumab | INJECTABLE; INJECTION | 125370 | HUMAN GENOME SCIENCES INC. | 07/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125370s078lbl.pdf#page=41 |
Besremi | Ropeginterferon Alfa-2b-Njft | INJECTABLE;SUBCUTANEOUS | 761166 | PHARMAESSENTIA CORP | 11/12/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf#page=18 |
Betaseron | Interferon Beta-1b | VIAL; SUBCUTANEOUS | 103471 | BAYER HEALTHCARE PHARMS | 11/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103471s5200lbl.pdf#page=19 |
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 | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761158s006lbl.pdf#page=22 |
Blincyto | Blinatumomab | INJECTABLE;INJECTION | 125557 | AMGEN | 02/18/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf#page=40 |
Boniva | Ibandronate Sodium | INJECTABLE;INTRAVENOUS | 021858 | ROCHE | 01/11/2022 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18 |
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 |
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 | 08/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103000s5322lbl.pdf#page=51 |
Botox Cosmetic | Onabotulinumtoxina | VIAL; SINGLE-USE | 103000 | ALLERGAN | 08/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103000s5322lbl.pdf#page=51 |
Braftovi | Encorafenib | CAPSULE;ORAL | 210496 | ARRAY BIOPHARMA INC | 02/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210496s013lbl.pdf#page=22 |
Brexafemme | Ibrexafungerp | TABLET;ORAL | 214900 | SCYNEXIS | 11/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s002lbl.pdf#page=18 |
Brilinta | Ticagrelor | TABLET;ORAL | 022433 | ASTRAZENECA | 05/09/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022433s034lbl.pdf#page=35 |
Brisdelle | Paroxetine Mesylate | CAPSULE;ORAL | 204516 | SEBELA IRELAND LTD | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204516s011lbl.pdf#page=16 |
Briviact | Brivaracetam | TABLET;ORAL | 205836 | UCB INC | 02/18/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.pdf#page=17 |
Briviact | Brivaracetam | SOLUTION;INTRAVENOUS | 205837 | UCB INC | 02/18/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.pdf#page=17 |
Briviact | Brivaracetam | SOLUTION;ORAL | 205838 | UCB INC | 02/18/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.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 | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf#page=33 |
Butrans | Buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | PURDUE PHARMA LP | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021306s039lbl.pdf#page=43 |
Bydureon | Exenatide Synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf#page=37 |
Bydureon Bcise | Exenatide Synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s022lbl.pdf#page=36 |
Bydureon Pen | Exenatide Synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf#page=37 |
Byetta | Exenatide Synthetic | INJECTABLE; SUBCUTANEOUS | 021919 | AMYLIN | 10/30/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf |
Byetta | Exenatide Synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf#page=33 |
Cambia | Diclofenac Potassium | FOR SOLUTION;ORAL | 022165 | ASSERTIO | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf#page=23 |
Caplyta | Lumateperone Tosylate | CAPSULE;ORAL | 209500 | INTRA-CELLULAR | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209500s009lbl.pdf#page=22 |
Caprelsa | Vandetanib | TABLET;ORAL | 022405 | GENZYME CORP | 03/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022405s019lbl.pdf#page=20 |
Carbatrol | Carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712 | TAKEDA PHARMS USA | 12/01/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf |
Cassipa | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;SUBLINGUAL | 208042 | TEVA PHARMS USA | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208042s005s007lbl.pdf#page=30 |
Cataflam | Diclofenac Potassium | TABLET;ORAL | 020142 | NOVARTIS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020142s029lbl.pdf#page=19 |
Celebrex | Celecoxib | CAPSULE;ORAL | 020998 | UPJOHN | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf#page=22 |
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 | SOLUTION;ORAL | 021046 | FOREST LABS | 12/03/2012 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf#page=32 |
Celexa | Citalopram Hydrobromide | TABLET;ORAL | 020822 | ALLERGAN | 02/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf#page=32 |
Cellcept | Mycophenolate Mofetil | CAPSULE;ORAL | 050722 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Cellcept | Mycophenolate Mofetil | TABLET;ORAL | 050723 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Cellcept | Mycophenolate Mofetil Hydrochloride | INJECTABLE;INJECTION | 050758 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Cellcept | Mycophenolate Mofetil | FOR SUSPENSION;ORAL | 050759 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
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/2018/205494s003lbl.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 |
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 |
Cibinqo | Abrocitinib | TABLET; ORAL | 213871 | PFIZER INC | 01/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213871s000lbl.pdf#page=26 |
Cimzia | Certolizumab Pegol | INJECTABLE; INJECTION | 125160 | UCB INC | 12/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125160s305lbl.pdf#page=40 |
Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 03/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847s063lbl.pdf#page=33 |
Cipro | Ciprofloxacin Hydrochloride | TABLET;ORAL | 019537 | BAYER HLTHCARE | 07/26/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s092lbl.pdf#page=39 |
Cipro | Ciprofloxacin | FOR SUSPENSION;ORAL | 020780 | BAYER HLTHCARE | 07/26/2017 | 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 | 03/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019857s073lbl.pdf#page=33 |
Cipro XR | Ciprofloxacin; Ciprofloxacin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473 | BAYER HLTHCARE | 07/26/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021473s043lbl.pdf#page=30 |
Citalopram | Citalopram Hydrobromide | CAPSULE; ORAL | 215428 | ALMATICA | 01/31/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215428s000lbl.pdf#page=23 |
Clenpiq | Citric Acid; Magnesium Oxide; Sodium Picosulfate | SOLUTION;ORAL | 209589 | FERRING PHARMS INC | 08/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209589s014lbl.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/2021/202245s009lbl.pdf#page=29 |
Colcrys | Colchicine | TABLET; ORAL | 022353 | AR HOLDING CO INC | 10/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf#page=19 |
Colcrys | Colchicine | TABLET;ORAL | 022352 | TAKEDA PHARMS USA | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf#page=25 |
Combunox | Ibuprofen; Oxycodone Hydrochloride | TABLET;ORAL | 021378 | FOREST LABS | 09/02/2010 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021378s006lbl.pdf#page=30 |
Concerta | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | JANSSEN PHARMS | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021121s044lbl.pdf#page=30 |
Consensi | Amlodipine Besylate; Celecoxib | TABLET;ORAL | 210045 | PURPLE BIOTECH | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210045s009lbl.pdf#page=10 |
Contrave | Bupropion Hydrochloride; Naltrexone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NALPROPION | 04/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf#page=40 |
Conzip | Tramadol Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022370 | CIPHER PHARMS INC | 09/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s023lbl.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 |
Copiktra | Duvelisib | CAPSULE;ORAL | 211155 | SECURA | 12/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s005lbl.pdf#page=28 |
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 | SOLUTION;ORAL | 209964 | AMGEN INC | 08/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf#page=24 |
Corlanor | Ivabradine Hydrochloride | TABLET;ORAL | 206143 | AMGEN INC | 08/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf#page=24 |
Cosentyx | Secukinumab | INJECTABLE;INJECTION | 125504 | NOVARTIS PHARMS CORP | 12/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf#page=24 |
Cotempla XR-Odt | Methylphenidate | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 205489 | NEOS THERAPS INC | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf#page=22 |
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 | 06/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020725s028lbl.pdf#page=16 |
Cyltezo | Adalimumab-Adbm | INJECTABLE;INJECTION | 761058 | BOEHRINGER INGELHEIM | 10/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf#page=33 |
Cymbalta | Duloxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | LILLY | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021427s056lbl.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 |
Daxxify | Daxibotulinumtoxina-Lanm | INJECTABLE;INTRAMUSCULAR | 761127 | REVANCE THERAPEUTICS, INC | 09/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761127s000lbl.pdf#page=14 |
Daypro | Oxaprozin | TABLET;ORAL | 018841 | PFIZER | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018841s033lbl.pdf#page=25 |
Daypro Alta | Oxaprozin Potassium | TABLET;ORAL | 020776 | PFIZER | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020776s010lbl.pdf#page=22 |
Daytrana | Methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514 | NOVEN PHARMS INC | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021514s032lbl.pdf#page=25 |
Dayvigo | Lemborexant | TABLET;ORAL | 212028 | EISAI INC | 03/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212028s006lbl.pdf#page=21 |
Demerol | Meperidine Hydrochloride | TABLET;ORAL | 005010 | VALIDUS PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32 |
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 |
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 | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018723s065lbl.pdf#page=48 |
Depakote | Divalproex Sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 019680 | ABBVIE | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s052lbl.pdf#page=42 |
Depakote ER | Divalproex Sodium | TABLET, EXTENDED RELEASE;ORAL | 021168 | ABBVIE | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s043lbl.pdf#page=48 |
Descovy | Emtricitabine; Tenofovir Alafenamide Fumarate | TABLET;ORAL | 208215 | GILEAD SCIENCES INC | 01/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf#page=37 |
Desoxyn | Methamphetamine Hydrochloride | TABLET;ORAL | 005378 | RECORDATI RARE | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf#page=12 |
Desoxyn | Methamphetamine Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 005378 | RECORDATI RARE | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf#page=12 |
Desvenlafaxine | Desvenlafaxine Fumarate | TABLET, EXTENDED RELEASE;ORAL | 205208 | TEVA PHARMS USA | 07/18/2014 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205208Orig1s001lbl.pdf#page=23 |
Desvenlafaxine | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204150 | ALEMBIC PHARMS LTD | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204150s018lbl.pdf#page=32 |
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 | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017078s054lbl.pdf#page=14 |
Dexilant | Dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287 | TAKEDA PHARMS USA | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022287s035lbl.pdf#page=24 |
Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | SOLUTION;ORAL | 040776 | OUTLOOK PHARMS | 01/04/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/40776MG.pdf#page=7 |
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 |
Diacomit | Stiripentol | CAPSULE;ORAL | 206709 | 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 | 09/07/2022 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/084349s088lbl.pdf#page=21 |
Dilantin | Phenytoin | TABLET, CHEWABLE;ORAL | 084427 | PHARMACIA | 10/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf#page=17 |
Dilantin-125 | Phenytoin | SUSPENSION;ORAL | 008762 | UPJOHN | 03/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf#page=19 |
Dilantin-30 | Phenytoin | SUSPENSION;ORAL | 008762 | UPJOHN | 03/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf#page=19 |
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 | 06/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf#page=36 |
Dolophine Hydrochloride | Methadone Hydrochloride | TABLET;ORAL | 006134 | HIKMA | 06/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf#page=36 |
Doral | Quazepam | TABLET;ORAL | 018708 | GALT PHARMS | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf#page=11 |
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 REL PELLETS;ORAL | 212516 | SUN PHARMA GLOBAL | 07/23/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212516s002lbl.pdf#page=46 |
Droxia | Hydroxyurea | CAPSULE;ORAL | 016295 | BRISTOL MYERS SQUIBB | 07/22/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016295s056MG.pdf |
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 | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf#page=25 |
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 | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 10 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 15 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 20 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 5 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dysport | Abobotulinumtoxina | INJECTABLE; INJECTION | 125274 | IPSEN BIOPHARM LTD | 01/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125274s123lbl.pdf#page=30 |
EC-Naprosyn | Naproxen | TABLET, DELAYED RELEASE;ORAL | 020067 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf#page=23 |
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 | 08/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/20699s112lbl.pdf#page=38 |
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/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 | 10/12/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s034lbl.pdf#page=38 |
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 |
Elucirem | Gadopiclenol | INJECTABLE;INTRAVENOUS | 216986 | LIEBEL-FLARSHEIM COMPANY | 09/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf#page=17 |
Elyxyb | Celecoxib | SOLUTION;ORAL | 212157 | BDSI | 04/28/2021 | 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/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 |
Enbrel | Etanercept | VIAL; SUBCUTANEOUS | 103795 | IMMUNEX | 02/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35 |
Enbrel | Etanercept | SYRINGE | 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 | 08/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s022lbl.pdf#page=31 |
Enjaymo | Sutimlimab-Jome | INJECTABLE;INJECTION | 761164 | BIOVERATIV THERAPEUTICS INC | 02/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf#page=13 |
Enspryng | Satralizumab-Mwge | INJECTABLE;SUBCUTANEOUS | 761149 | GENETECH, INC | 09/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf#page=16 |
Entyvio | Vedolizumab | INJECTABLE;INJECTION | 125476 | TAKEDA PHARMS USA | 08/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.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 | 12/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090s020lbledt.pdf#page=15 |
Epidiolex | Cannabidiol | SOLUTION;ORAL | 210365 | GW RES LTD | 02/24/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210365s015lbl.pdf#page=32 |
Epogen | 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 | 12/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s029lbl.pdf#page=28 |
Equetro | Carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710 | VALIDUS PHARMS | 10/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021710s018lbl.pdf#page=27 |
Erelzi | Etanercept-Szzs | INJECTABLE; INJECTION | 761042 | SANDOZ | 11/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761042s018lbl.pdf#page=41 |
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 | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202342s007lbl.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 | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s003MedGuide.pdf |
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 | 022042 | LILLY | 09/13/2007 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf |
Evista | Raloxifene Hydrochloride | TABLET;ORAL | 020815 | LILLY | 06/27/2018 | 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 | 11/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125290s073lbl.pdf#page=16 |
Factive | Gemifloxacin Mesylate | TABLET;ORAL | 021158 | LG CHEM LTD | 07/26/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf#page=30 |
Farxiga | Dapagliflozin | TABLET;ORAL | 202293 | ASTRAZENECA AB | 07/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202293Orig1s027lbl.pdf#page=50 |
Farydak | Panobinostat LActate | CAPSULE;ORAL | 205353 | SECURA | 06/06/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf |
Felbatol | Felbamate | TABLET;ORAL | 020189 | MYLAN SPECIALITY LP | 08/31/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf |
Felbatol | Felbamate | SUSPENSION;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 | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf#page=21 |
Fensolvi Kit | Leuprolide Acetate | POWDER;SUBCUTANEOUS | 213150 | TOLMAR | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s002lbl.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 | 12/03/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf |
Fentora | Fentanyl Citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | CEPHALON | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021947s038lbl.pdf#page=42 |
Ferriprox | Deferiprone | TABLET;ORAL | 021825 | CHIESI | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf#page=17 |
Ferriprox | Deferiprone | TABLET;ORAL | 212269 | CHIESI | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212269s003lbl.pdf#page=17 |
Ferriprox | Deferiprone | SOLUTION;ORAL | 208030 | CHIESI | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s007lbl.pdf#page=13 |
Fetzima | Levomilnacipran Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168 | ALLERGAN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf#page=28 |
Fintepla | Fenfluramine Hydrochloride | SOLUTION;ORAL | 212102 | ZOGENIX INC | 01/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s006lbl.pdf#page=30 |
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 | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf#page=39 |
Firdapse | Amifampridine Phosphate | TABLET;ORAL | 208078 | CATALYST PHARMS | 09/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208078s008lbl.pdf#page=12 |
Flector | Diclofenac Epolamine | SYSTEM;TOPICAL | 021234 | INST BIOCHEM | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021234s019lbl.pdf#page=24 |
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 | ALMATICA | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202133s012lbl.pdf#page=35 |
Focalin | Dexmethylphenidate Hydrochloride | TABLET;ORAL | 021278 | NOVARTIS | 06/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021278s029lbl.pdf#page=15 |
Focalin XR | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802 | NOVARTIS | 06/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021802s039lbl.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 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021592s003lbl.pdf#page=35 |
Forfivo XL | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022497 | ALMATICA | 12/10/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022497s008lbl.pdf#page=33 |
Forteo | Teriparatide | SOLUTION;SUBCUTANEOUS | 021318 | LILLY | 09/07/2021 | 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 | SOLUTION;ORAL | 021575 | MERCK | 11/30/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24 |
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 Plus D | Alendronate Sodium; Cholecalciferol | TABLET;ORAL | 021762 | ORGANON | 08/16/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf |
Fosamax Plus D | Alendronate Sodium; Cholecalciferol | TABLET;ORAL | 021762 | ORGANON | 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/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/2020/021468s023,204734s005lbl.pdf#page=12 |
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/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 | 04/27/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201277s020lbl.pdf#page=42 |
Gattex Kit | Teduglutide Recombinant | POWDER;SUBCUTANEOUS | 203441 | NPS PHARMS INC | 02/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203441s018lbl.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 | ROMEG | 02/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210942Orig1s001lbl.pdf#page=12 |
Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s033lbl.pdf#page=32 |
Golytely | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous | FOR SOLUTION;ORAL | 019011 | BRAINTREE | 05/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019011s033lbl.pdf#page=9 |
Gralise | Gabapentin | TABLET;ORAL | 022544 | ALMATICA | 09/16/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022544s026lbl.pdf#page=19 |
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 | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf#page=40 |
Halcion | Triazolam | TABLET;ORAL | 017892 | PFIZER | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017892s057lbl.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 |
Hemangeol | Propranolol Hydrochloride | SOLUTION;ORAL | 205410 | PIERRE FABRE DERMA | 06/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf#page=11 |
Hemlibra | Emicizumab | INJECTABLE;INJECTION | 761083 | GENENTECH INC | 06/06/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761083s015lbl.pdf#page=22 |
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/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 | TABLET;ORAL | 005213 | GENUS | 09/27/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213s044lbl.pdf#page=27 |
Hycodan | Homatropine METhylbromide; Hydrocodone Bitartrate | SYRUP;ORAL | 005213 | GENUS | 09/27/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213s044lbl.pdf#page=27 |
Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204278 | PADAGIS US | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf |
Hyrimoz | Adalimumab-Adaz | INJECTABLE;INJECTION | 761071 | SANDOZ INC | 07/18/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf#page=41 |
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 | 04/05/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.pdf#page=14 |
Iclusig | Ponatinib Hydrochloride | TABLET;ORAL | 203469 | TAKEDA PHARMS USA | 02/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203469s035lbl.pdf#page=34 |
Idhifa | Enasidenib Mesylate | TABLET;ORAL | 209606 | CELGENE CORP | 07/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf#page=17 |
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 | 11/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761069s033lbl.pdf#page=51 |
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 |
Imjudo | Tremelimumab-Actl | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 761270 | ASTRAZENECA | 11/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf#page=32 |
Incivek | Telaprevir | TABLET;ORAL | 201917 | VERTEX PHARMS | 03/25/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf |
Indocin | Indomethacin | SUPPOSITORY;RECTAL | 017814 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017814s044lbl.pdf#page=24 |
Indocin | Indomethacin | CAPSULE;ORAL | 016059 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016059s101lbl.pdf#page=24 |
Indocin | Indomethacin | SUSPENSION;ORAL | 018332 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018332s042lbl.pdf#page=24 |
Indocin SR | Indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018185s058lbl.pdf#page=25 |
Indomethacin | Indomethacin | CAPSULE;ORAL | 018829 | CHARTWELL MOLECULES | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018829s023lbl.pdf#page=18 |
Indomethacin | Indomethacin | CAPSULE;ORAL | 018851 | HERITAGE | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf#page=23 |
Indomethacin | Indomethacin | CAPSULE;ORAL | 018858 | RISING | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018858s047lbl.pdf#page=26 |
Inflectra | Infliximab-Dyyb | INJECTABLE;INJECTION | 125544 | CELLTRION INC | 06/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125544s018lbl.pdf#page=61 |
Inrebic | Fedratinib Hydrochloride | CAPSULE;ORAL | 212327 | IMPACT | 12/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212327s003lbl.pdf#page=20 |
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 | 11/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf#page=40 |
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 |
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 |
Invokamet | Canagliflozin; METformin Hydrochloride | TABLET;ORAL | 204353 | JANSSEN PHARMS | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204353s041,205879s018lbl.pdf#page=59 |
Invokamet XR | Canagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879 | JANSSEN PHARMS | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204353s041,205879s018lbl.pdf#page=59 |
Invokana | Canagliflozin | TABLET;ORAL | 204042 | JANSSEN PHARMS | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204042s039lbl.pdf#page=48 |
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/2020/206910s015lbl.pdf#page=31 |
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 | 06/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf#page=33 |
Janumet XR | Metformin Hydrochloride; Sitagliptin Phosphate | TABLET, EXTENDED RELEASE;ORAL | 202270 | MERCK SHARP DOHME | 06/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf#page=34 |
Januvia | Sitagliptin Phosphate | TABLET;ORAL | 021995 | MERCK SHARP DOHME | 06/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf#page=27 |
Jardiance | Empagliflozin | TABLET;ORAL | 204629 | BOEHRINGER INGELHEIM | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s039lbl.pdf#page=40 |
Jemperli | Dostarlimab-Gxly | INJECTABLE;INJECTION | 761223 | GLAXOSMITHKLINE LLC | 08/17/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761223s000lbl.pdf#page=25 |
Jemperli | Dostarlimab-Gxly | INJECTABLE;INJECTION | 761174 | GLAXOSMITHKLINE | 04/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf#page=25 |
Jentadueto | Linagliptin; METformin Hydrochloride | TABLET;ORAL | 201281 | BOEHRINGER INGELHEIM | 04/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201281s031lbl.pdf#page=21 |
Jentadueto XR | Linagliptin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026 | BOEHRINGER INGELHEIM | 10/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208026s020lbl.pdf#page=21 |
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 | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209311s008lbl.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 | 05/27/2021 | 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 | TABLET;ORAL | 021906 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53 |
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 | CAPSULE;ORAL | 021226 | ABBVIE | 10/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf#page=53 |
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/2020/021035s104,021505s044lbl.pdf#page=31 |
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 | 09/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125326s075lbl.pdf#page=13 |
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 | SOLUTION;INTRAVENOUS | 125514 | MERCK SHARP DOHME | 05/20/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s123lbl.pdf#page=126 |
Khedezla | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204683 | OSMOTICA PHARM CORP | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204683s007lbl.pdf#page=24 |
Klonopin | Clonazepam | TABLET;ORAL | 017533 | CHEPLAPHARM | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf#page=24 |
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 |
Konvomep | Omeprazole; Sodium Bicarbonate | SUSPENSION;ORAL | 213593 | AZURITY | 08/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213593s000lbl.pdf#page=28 |
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 | 07/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125293s104lbl.pdf#page=18 |
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 | 08/10/2021 | 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, FOR SUSPENSION;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/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 | GRANULE;ORAL | 022071 | NOVARTIS | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf#page=10 |
Lamisil | Terbinafine Hydrochloride | TABLET;ORAL | 020539 | NOVARTIS | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf#page=11 |
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 | 12/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022569s030lbl.pdf#page=35 |
Lemtrada | Alemtuzumab | INJECTABLE;INJECTION | 103948 | GENZYME | 05/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5185lbl.pdf#page=30 |
Leqembi | Ecanemab-Irmb | INJECTABLE;INTRAVENOUS | 761269 | EISAI INC | 01/06/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s000lbl.pdf#page=16 |
Letairis | Ambrisentan | TABLET;ORAL | 022081 | GILEAD | 06/08/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf#page=26 |
Levaquin | Levofloxacin | SOLUTION;ORAL | 021721 | JANSSEN PHARMS | 02/08/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf#page=59 |
Levaquin | Levofloxacin | TABLET;ORAL | 020634 | JANSSEN PHARMS | 02/08/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020634s073lbl.pdf#page=54 |
Levaquin | Levofloxacin | INJECTABLE;INJECTION | 020635 | JANSSEN PHARMS | 02/08/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf#page=59 |
Levaquin | Levofloxacin | INJECTABLE;INJECTION | 020635 | JANSSEN PHARMS | 02/08/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf#page=59 |
Lexapro | Escitalopram Oxalate | TABLET;ORAL | 021323 | ALLERGAN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf#page=21 |
Lexapro | Escitalopram Oxalate | SOLUTION;ORAL | 021365 | ALLERGAN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf#page=21 |
Librax | Chlordiazepoxide Hydrochloride; Clidinium Bromide | CAPSULE;ORAL | 012750 | BAUSCH | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012750s068lbl.pdf#page=13 |
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 | 11/08/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf#page=35 |
Licart | Diclofenac Epolamine | SYSTEM;TOPICAL | 206976 | IBSA INST BIO | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206976s007lbl.pdf#page=21 |
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 | 08/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf#page=21 |
Lithium Carbonate | Lithium Carbonate | CAPSULE;ORAL | 017812 | HIKMA | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf#page=19 |
Lithium Carbonate | Lithium Carbonate | TABLET;ORAL | 018558 | HIKMA | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf#page=19 |
Lithium Citrate | Lithium Citrate | SYRUP;ORAL | 018421 | HIKMA | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf#page=19 |
Loreev XR | Lorazepam | CAPSULE, EXTENDED RELEASE;ORAL | 214826 | Almatica Pharma | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214826s003lbl.pdf#page=16 |
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/2020/761104s003lbl.pdf#page=18 |
Lunesta | Eszopiclone | TABLET;ORAL | 021476 | SUNOVION PHARMS INC | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf#page=26 |
Lunsumio | Mosunetuzumab-Axgb | INJECTABLE;INTRAVENOUS | 761263 | GENENTECH, INC | 12/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761263s000lbl.pdf#page=21 |
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 | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020263s050lbl.pdf#page=23 |
Luvox | Fluvoxamine Maleate | TABLET;ORAL | 021519 | ANI PHARMS | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf#page=31 |
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 |
Lybalvi | Olanzapine; Samidorphan L-Malate | TABLET;ORAL | 213378 | ALKERMES INC | 05/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf#page=40 |
Lynparza | Olaparib | TABLET;ORAL | 208558 | ASTRAZENECA | 08/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s026lbl.pdf#page=54 |
Lynparza | Olaparib | CAPSULE;ORAL | 206162 | ASTRAZENECA | 09/27/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16 |
Lyrica | Pregabalin | SOLUTION;ORAL | 022488 | UPJOHN | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56 |
Lyrica | Pregabalin | CAPSULE;ORAL | 021446 | UPJOHN | 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 | UPJOHN | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29 |
Magnevist | Gadopentetate Dimeglumine | INJECTABLE;INJECTION | 021037 | BAYER HLTHCARE | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13 |
Magnevist | Gadopentetate Dimeglumine | INJECTABLE;INJECTION | 019596 | BAYER HLTHCARE | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12 |
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 | 09/19/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022561s006lbl.pdf#page=29 |
Mayzent | Siponimod Fumaric Acid | TABLET;ORAL | 209884 | NOVARTIS | 06/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884Orig1s011lbl.pdf#page=23 |
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 | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021259s025lbl.pdf#page=16 |
Methylin | Methylphenidate Hydrochloride | TABLET, CHEWABLE;ORAL | 021475 | SPECGX LLC | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021475s011lbl.pdf#page=13 |
Methylin | Methylphenidate Hydrochloride | SOLUTION;ORAL | 021419 | SPECGX LLC | 07/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s010lbl.pdf#page=16 |
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 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf#page=18 |
Mifeprex | Mifepristone | TABLET; ORAL | 020687 | DANCO LABS LLC | 01/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020687s025lbl.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 AMERICAS | 09/26/2014 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf#page=11 |
Mitigare | Colchicine | CAPSULE;ORAL | 204820 | HIKMA INTL PHARMS | 09/26/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf |
Mobic | Meloxicam | SUSPENSION;ORAL | 021530 | AVONDALE PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021530s017lbl.pdf#page=16 |
Mobic | Meloxicam | TABLET;ORAL | 020938 | BOEHRINGER INGELHEIM | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf#page=16 |
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 | TABLET;ORAL | 022207 | HIKMA | 06/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf#page=26 |
Morphine Sulfate | Morphine Sulfate | SOLUTION;ORAL | 022195 | HIKMA | 07/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf#page=29 |
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 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf#page=13 |
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 | 05/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021881s023lbl.pdf#page=13 |
Moxifloxacin Hydrochloride | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 205572 | FRESENIUS KABI USA | 07/26/2016 | 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 | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125390s024lbl.pdf#page=16 |
Mydayis | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf#page=22 |
Myfortic | Mycophenolic Sodium | TABLET, DELAYED RELEASE;ORAL | 050791 | NOVARTIS | 03/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050791s035lbl.pdf#page=23 |
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 | 04/28/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf |
Naprelan | Naproxen Sodium | TABLET, EXTENDED RELEASE;ORAL | 020353 | ALMATICA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf#page=23 |
Naprosyn | Naproxen | TABLET;ORAL | 017581 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s064lbl.pdf#page=23 |
Naprosyn | Naproxen | SUSPENSION;ORAL | 018965 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018965s027lbl.pdf#page=23 |
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/2018/125511s016lbl.pdf#page=18 |
Nayzilam | Midazolam | SPRAY;NASAL | 211321 | UCB INC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211321s008lbl.pdf#page=26 |
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 | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf#page=41 |
Nexium | Esomeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022101 | ASTRAZENECA | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf#page=41 |
Nexium | Esomeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957 | ASTRAZENECA | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf#page=41 |
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 | SERENITY PHARMS LLC | 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 | 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 | 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/2021/200533s023lbl.pdf#page=37 |
Nulojix | Belatacept | INJECTABLE; INJECTION | 125288 | BRISTOL MYERS SQUIBB | 07/28/2021 | 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 | 05/14/2021 | 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 | 05/14/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf |
Nuvigil | Armodafinil | TABLET;ORAL | 021875 | CEPHALON | 02/07/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf#page=24 |
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 | 05/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207999s007lbl.pdf#page=22 |
Ocrevus | Ocrelizumab | INJECTABLE;INJECTION | 761053 | GENENTECH INC | 08/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf#page=20 |
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 | 05/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s006lbl.pdf#page=26 |
Omniscan | Gadodiamide | INJECTABLE;INJECTION | 022066 | GE HEALTHCARE | 10/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1 |
Omniscan | Gadodiamide | INJECTABLE;INJECTION | 020123 | GE HEALTHCARE | 11/07/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1 |
Omontys | Peginesatide Acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799 | TAKEDA PHARMS USA | 12/04/2012 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf#page=15 |
Onfi | Clobazam | SUSPENSION;ORAL | 203993 | LUNDBECK PHARMS LLC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf#page=29 |
Onfi | Clobazam | TABLET;ORAL | 202067 | LUNDBECK PHARMS LLC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf#page=29 |
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 | 12/03/2021 | 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 | 04/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021610s030lbl.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 | 07/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s114lbl.pdf#page=134 |
Opsumit | Macitentan | TABLET;ORAL | 204410 | ACTELION | 10/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204410s022lbl.pdf#page=20 |
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/2018/020975s028lbl.pdf#page=13 |
Optimark in Plastic Container | Gadoversetamide | INJECTABLE;INJECTION | 020976 | LIEBEL-FLARSHEIM | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf#page=13 |
Opzelura | Ruxolitinib Phosphate | CREAM;TOPICAL | 215309 | INCYTE CORP | 07/18/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf#page=19 |
Oriahnn (Copackaged) | Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | CAPSULE;ORAL | 213388 | ABBVIE INC | 08/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213388s001lbl.pdf#page=29 |
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 | 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 | 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 | SOLUTION;ORAL | 201194 | VISTAPHARM | 07/21/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf#page=33 |
Oxycodone Hydrochloride | Oxycodone Hydrochloride | SOLUTION;ORAL | 200535 | GENUS LIFESCIENCES | 07/21/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf#page=67 |
Oxycontin | Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | PURDUE PHARMA LP | 10/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s047lbl.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 | 10/06/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf#page=27 |
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 | 04/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf#page=16 |
Parnate | Tranylcypromine Sulfate | TABLET;ORAL | 012342 | CONCORDIA | 01/04/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012342s064lbl.pdf#page=18 |
Paxil | Paroxetine Hydrochloride | TABLET;ORAL | 020031 | APOTEX TECHNOLOGIES | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf#page=39 |
Paxil | Paroxetine Hydrochloride | SUSPENSION;ORAL | 020710 | APOTEX TECHNOLOGIES | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf#page=39 |
Paxil CR | Paroxetine Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936 | APOTEX TECHNOLOGIES | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020936s060lbl.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 | VIAL; SUBCUTANEOUS | 103964 | HOFFMAN-LA ROCHE | 03/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39 |
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 |
Pegintron | Peginterferon Alfa-2b | SYRINGE | 103949 | SCHERING | 12/21/2018 | 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 |
Pennsaid | Diclofenac Sodium | SOLUTION;TOPICAL | 204623 | HORIZON | 06/07/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623Orig1s010lbl.pdf#page=20 |
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; Oxycodone Terephthalate | TABLET;ORAL | 007337 | ENDO PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf#page=30 |
Percodan | Aspirin; Oxycodone Hydrochloride | TABLET;ORAL | 007337 | ENDO PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf#page=30 |
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 | 09/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf#page=13 |
Pexeva | Paroxetine Mesylate | TABLET;ORAL | 021299 | SEBELA IRELAND LTD | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021299s037lbl.pdf#page=19 |
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/2021/020839s074lbl.pdf#page=24 |
Plegridy | Peginterferon Beta-1a | INJECTABLE;INJECTION | 125499 | BIOGEN IDEC INC | 03/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125499s025lbl.pdf#page=20 |
Plenvu | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | FOR SOLUTION;ORAL | 209381 | SALIX | 05/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s002lbl.pdf#page=17 |
Pomalyst | Pomalidomide | CAPSULE;ORAL | 204026 | CELGENE | 08/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf#page=33 |
Ponstel | Mefenamic Acid | CAPSULE;ORAL | 015034 | AVION PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/015034s045lbl.pdf#page=19 |
Ponvory | Ponesimod | TABLET;ORAL | 213498 | JANSSEN PHARMS | 10/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.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 | 06/21/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s041lbl.pdf#page=27 |
Pradaxa | Dabigatran Etexilate Mesylate | PELLETS;ORAL | 214358 | BOEHRINGER INGELHEIM | 03/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214358Orig1s001lbl.pdf#page=14 |
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 | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf#page=45 |
Prevacid | Lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428 | TAKEDA PHARMS USA | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf#page=45 |
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 | 07/01/2015 | 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/2016/019810s103,022056s020lbl.pdf#page=34 |
Prilosec | Omeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056 | COVIS | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022056s025lbl.pdf#page=34 |
Pristiq | Desvenlafaxine Succinate | TABLET, EXTENDED RELEASE;ORAL | 021992 | PF PRISM CV | 11/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021992s047lbl.pdf#page=36 |
Probuphine | Buprenorphine Hydrochloride | IMPLANT;IMPLANTATION | 204442 | TITAN PHARMS | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204442s012lbl.pdf#page=48 |
Procrit | Epoetin Alfa | VIAL; SINGLE-USE | 103234 | AMGEN | 07/25/2018 | https://www.fda.gov/media/73511/download |
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 | 05/06/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf#page=16 |
Prolia | Denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | AMGEN | 01/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125320s211lbl.pdf#page=31 |
Promacta | Eltrombopag Olamine | TABLET;ORAL | 022291 | NOVARTIS | 03/31/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf#page=35 |
Promacta Kit | Eltrombopag Olamine | FOR SUSPENSION;ORAL | 207027 | NOVARTIS | 03/31/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.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 | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020 | WYETH PHARMS | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf#page=32 |
Protonix | Pantoprazole Sodium | TABLET, DELAYED RELEASE;ORAL | 020987 | WYETH PHARMS | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf#page=32 |
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 | 06/22/2009 | 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 | 09/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214044s000lbl.pdf#page=27 |
Qelbree | Viloxazine Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 211964 | SUPERNUS PHARMS | 04/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211964s003lbl.pdf#page=21 |
Qmiiz ODT | Meloxicam | TABLET, ORALLY DISINTEGRATING;ORAL | 211210 | TERSERA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211210s002lbl.pdf#page=37 |
Qsymia | Phentermine Hydrochloride; Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580 | VIVUS | 06/24/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf#page=44 |
Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s006lbl.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/2020/210874s003lbl.pdf#page=47 |
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 | 12/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s014lbl.pdf#page=54 |
Quillichew ER | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960 | NEXTWAVE PHARMS | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207960s012lbl.pdf#page=21 |
Quillivant XR | Methylphenidate Hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NEXTWAVE | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202100s018lbl.pdf#page=21 |
Quviviq | Daridorexant | TABLET; ORAL | 214985 | IDORSIA PHARMACEUTICALS LTD. | 11/08/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214985s002lbl.pdf#page=22 |
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 | 08/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021110s086lbl.pdf#page=43 |
Ravicti | Glycerol Phenylbutyrate | LIQUID;ORAL | 203284 | HORIZON THERAP | 09/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203284s012lbl.pdf#page=27 |
Rebetol | Ribavirin | CAPSULE;ORAL | 020903 | MERCK SHARP DOHME | 03/16/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf#page=26 |
Rebetol | Ribavirin | SOLUTION;ORAL | 021546 | SCHERING | 03/16/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf#page=26 |
Rebif | Interferon Beta-1a | SYRINGE | 103780 | SERONO INC | 11/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103780s5210lbl.pdf#page=16 |
Reclast | Zoledronic Acid | INJECTABLE;INTRAVENOUS | 021817 | NOVARTIS | 04/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021817s028lbl.pdf#page=25 |
Recorlev | Levoketoconazole | TABLET;ORAL | 214133 | STRONGBRIDGE | 12/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214133s000lbl.pdf#page=24 |
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 | HIKMA | 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/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 | 11/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23 |
Remeron Soltab | Mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | ORGANON USA INC | 11/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23 |
Remicade | Infliximab | VIAL | 103772 | CENTOCOR INC | 10/05/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf#page=50 |
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 | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018163s071lbl.pdf#page=17 |
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 | 05/24/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880s065lbl.pdf#page=48 |
Rexulti | Brexpiprazole | TABLET;ORAL | 205422 | OTSUKA | 12/27/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf#page=27 |
Reyvow | Lasmiditan Succinate | TABLET;ORAL | 211280 | ELI LILLY AND CO | 09/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211280s008lbl.pdf#page=15 |
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 | 06/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761140s001lbl.pdf#page=41 |
Rinvoq | Upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675 | ABBVIE INC | 03/16/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf#page=56 |
Ritalin | Methylphenidate Hydrochloride | TABLET;ORAL | 010187 | NOVARTIS | 06/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf#page=13 |
Ritalin LA | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284 | NOVARTIS | 06/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021284s043lbl.pdf#page=17 |
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 | 12/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf#page=56 |
Rituxan Hycela | Rituximab; Hyaluronidase (Human Recombinant) | SOLUTION;SUBCUTANEOUS | 761064 | GENENTECH INC | 06/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761064s013lbl.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/2021/209777s007lbl.pdf#page=39 |
Rozerem | Ramelteon | TABLET;ORAL | 021782 | TAKEDA PHARMS USA | 11/03/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021782s022lbl.pdf#page=17 |
Ruxience | Rituximab-Pvvr | INJECTABLE;INJECTION | 761103 | PFIZER INC | 11/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf#page=42 |
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 | 01/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf#page=24 |
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 | FOR SOLUTION;ORAL | 022006 | LUNDBECK PHARMS LLC | 10/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf#page=26 |
Sabril | Vigabatrin | TABLET;ORAL | 020427 | LUNDBECK PHARMS LLC | 10/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf#page=26 |
Samsca | Tolvaptan | TABLET;ORAL | 022275 | OTSUKA | 04/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022275s017lbl.pdf#page=19 |
Sarafem | Fluoxetine Hydrochloride | TABLET;ORAL | 021860 | APIL | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021860s015lbl.pdf#page=32 |
Savaysa | Edoxaban Tosylate | TABLET;ORAL | 206316 | DAIICHI SANKYO INC | 11/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf#page=35 |
Savella | Milnacipran Hydrochloride | TABLET;ORAL | 022256 | ALLERGAN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022256s025lbl.pdf#page=31 |
Saxenda | Liraglutide Recombinant | SOLUTION;SUBCUTANEOUS | 206321 | NOVO | 06/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206321s015lbl.pdf#page=30 |
Seglentis | Celecoxib; Tramadol Hydrochloride | TABLET;ORAL | 213426 | KOWA PHARMS | 10/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213426s000lbl.pdf#page=56 |
Segluromet | Ertugliflozin; METformin Hydrochloride | TABLET;ORAL | 209806 | MERCK SHARP DOHME | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s009lbl.pdf#page=33 |
Selzentry | Maraviroc | SOLUTION;ORAL | 208984 | VIIV HLTHCARE | 10/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.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 |
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 | 01/31/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020639s072lbl.pdf#page=49 |
Seroquel XR | Quetiapine Fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047 | ASTRAZENECA | 01/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022047s046lbl.pdf#page=53 |
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 | 12/07/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208843s003lbl.pdf#page=18 |
Silenor | Doxepin Hydrochloride | TABLET;ORAL | 022036 | CURRAX | 10/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf#page=19 |
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/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/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25 |
Sirturo | Bedaquiline Fumarate | TABLET;ORAL | 204384 | JANSSEN THERAP | 12/09/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204384s016lbl.pdf#page=28 |
Skyrizi | Risankizumab-Rzaa | INJECTABLE;INJECTION | 761105 | ABBVIE INC | 09/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s018lbl.pdf#page=30 |
Skyrizi | Risankizumab-Rzaa | INJECTABLE;SUBCUTANEOUS | 761262 | ABBVIE INC | 09/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf#page=30 |
Sodium Oxybate | Sodium Oxybate | SOLUTION;ORAL | 202090 | HIKMA | 01/03/2022 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18 |
Solaraze | Diclofenac Sodium | GEL;TOPICAL | 021005 | FOUGERA PHARMS | 04/28/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf |
Solaraze | Diclofenac Sodium | GEL;TOPICAL | 021005 | FOUGERA PHARMS | 11/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s024lbl.pdf#page=22 |
Soliqua 100/33 | Insulin Glargine; Lixisenatide | SOLUTION;SUBCUTANEOUS | 208673 | SANOFI-AVENTIS US | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf#page=29 |
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 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf#page=36 |
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 |
Sotyktu | Deucravacitinib | TABLET;ORAL | 214958 | BRISTOL MYERS SQUIBB | 09/09/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214958s000lbl.pdf#page=19 |
Spevigo | Spesolimab-Sbzo | INJECTABLE;INTRAVENOUS | 761244 | Boehringer Ingelheim Pharmaceuticals, Inc | 09/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf#page=11 |
Spravato | Esketamine Hydrochloride | SPRAY;NASAL | 211243 | JANSSEN PHARMS | 01/03/2022 | 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/2021/207958s019lbl.pdf#page=36 |
Sprix | Ketorolac Tromethamine | SPRAY, METERED;NASAL | 022382 | ZYLA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022382s021lbl.pdf#page=22 |
Stavzor | Valproic Acid | CAPSULE, DELAYED RELEASE;ORAL | 022152 | BIONPHARMA INC | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022152s009lbl.pdf#page=42 |
Steglatro | Ertugliflozin | TABLET;ORAL | 209803 | MERCK SHARP DOHME | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209803s006lbl.pdf#page=25 |
Steglujan | Ertugliflozin; Sitagliptin Phosphate | TABLET;ORAL | 209805 | MERCK SHARP DOHME | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s012lbl.pdf#page=31 |
Stelara | Ustekinumab | INJECTABLE;INJECTION | 761044 | JANSSEN BIOTECH | 07/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761044s010lbl.pdf#page=37 |
Stelara | Ustekinumab | INJECTABLE; INJECTION | 125261 | CENTOCOR ORTHO BIOTECH INC | 07/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf#page=37 |
Strattera | Atomoxetine Hydrochloride | CAPSULE;ORAL | 021411 | LILLY | 01/06/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021411s050lbl.pdf#page=20 |
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 | 09/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf#page=45 |
Suboxone | Buprenorphine Hydrochloride; Naloxone Hydrochloride | TABLET;SUBLINGUAL | 020733 | INDIVIOR INC | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020733s031s032lbl.pdf#page=32 |
Suboxone | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;BUCCAL, SUBLINGUAL | 022410 | INDIVIOR INC | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf#page=35 |
Subsys | Fentanyl | SPRAY;SUBLINGUAL | 202788 | BTCP PHARMA | 12/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf#page=40 |
Subutex | Buprenorphine Hydrochloride | TABLET;SUBLINGUAL | 020732 | INDIVIOR INC | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.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 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203595s000lbl.pdf#page=13 |
Sunosi | Solriamfetol Hydrochloride | TABLET;ORAL | 211230 | JAZZ | 03/20/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230_Orig1Orig2s000lbl.pdf#page=23 |
Supprelin LA | Histrelin Acetate | IMPLANT;SUBCUTANEOUS | 022058 | ENDO PHARM | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022058s017lbl.pdf#page=20 |
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 | Magnesium Sulfate; Potassium Chloride; Sodium Sulfate | TABLET;ORAL | 213135 | BRAINTREE LABS | 02/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213135s003lbl.pdf#page=15 |
Sutent | Sunitinib Malate | CAPSULE;ORAL | 021938 | CPPI CV | 08/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021938s039lbledt.pdf#page=34 |
Sylatron | Peginterferon Alfa-2b | VIAL | 103949 | SCHERING | 12/21/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13 |
Symbyax | Fluoxetine Hydrochloride; Olanzapine | CAPSULE;ORAL | 021520 | LILLY | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s054lbl.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 | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210833s004lbl.pdf#page=26 |
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 | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011483s034lbl.pdf#page=28 |
Synarel | Nafarelin Acetate | SPRAY, METERED;NASAL | 019886 | PFIZER | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019886s038lbl.pdf#page=28 |
Synjardy | Empagliflozin; METformin Hydrochloride | TABLET;ORAL | 206111 | BOEHRINGER INGELHEIM | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s036lbl.pdf#page=35 |
Synjardy XR | Empagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658 | BOEHRINGER INGELHEIM | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s023lbl.pdf#page=36 |
Synribo | Omacetaxine Mepesuccinate | POWDER;SUBCUTANEOUS | 203585 | TEVA PHARMS INTL | 05/12/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf#page=18 |
Tafinlar | Dabrafenib Mesylate | CAPSULE;ORAL | 202806 | NOVARTIS | 06/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s022lbl.pdf#page=40 |
Taltz | Ixekizumab | INJECTABLE;INJECTION | 125521 | ELI LILLY AND CO | 07/27/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf#page=21 |
Tanzeum | Albiglutide | INJECTABLE;INJECTION | 125431 | GLAXOSMITHKLINE LLC | 12/20/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf#page=36 |
Targiniq | Naloxone Hydrochloride; Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777 | PURDUE PHARMA LP | 09/18/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf#page=47 |
Tasigna | Nilotinib Hydrochloride | CAPSULE;ORAL | 022068 | NOVARTIS | 09/23/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf#page=36 |
Tavneos | Avacopan | CAPSULE;ORAL | 214487 | CHEMOCENTRYX | 10/07/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214487s000lbl.pdf#page=17 |
Tazverik | Tazemetostat Hydrobromide | TABLET;ORAL | 213400 | EPIZYME INC | 06/18/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213400s000lbl.pdf#page=17 |
Tazverik | Tazemetostat Hydrobromide | TABLET;ORAL | 211723 | EPIZYME INC | 01/23/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211723s000lbl.pdf#page=14 |
Tecentriq | Atezolizumab | INJECTABLE;INJECTION | 761034 | GENENTECH INC | 12/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s050lbl.pdf#page=57 |
Tecentriq | Atezolizumab | INJECTABLE; INJECTION | 761041 | GENENTECH INC | 10/18/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041s000lbl.pdf#page=22 |
Technivie | Ombitasvir; Paritaprevir; Ritonavir | TABLET;ORAL | 207931 | ABBVIE INC | 12/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207931s013lbl.pdf#page=39 |
Tegretol | Carbamazepine | SUSPENSION;ORAL | 018927 | NOVARTIS | 03/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19 |
Tegretol | Carbamazepine | TABLET, CHEWABLE;ORAL | 018281 | NOVARTIS | 03/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19 |
Tegretol | Carbamazepine | TABLET;ORAL | 016608 | NOVARTIS | 03/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19 |
Tegretol-XR | Carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234 | NOVARTIS | 03/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19 |
Tegsedi | Inotersen Sodium | SOLUTION;SUBCUTANEOUS | 211172 | AKCEA THERAPS | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211172s010lbl.pdf#page=28 |
Testim | Testosterone | GEL;TRANSDERMAL | 021454 | AUXILIUM PHARMS LLC | 08/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf#page=21 |
Testosterone | Testosterone | GEL;TRANSDERMAL | 202763 | ANI PHARMS | 10/25/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000mg.pdf |
Testosterone Cypionate Injection | Testosterone Cypionate | INJECTABLE;INTRAMUSCULAR | 216318 | SLAYBACK PHARMA LLC | 06/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216318s000lbl.pdf#page=14 |
Thalomid | Thalidomide | CAPSULE;ORAL | 020785 | CELGENE | 08/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020785s068lbl.pdf#page=23 |
Tibsovo | Ivosidenib | TABLET;ORAL | 211192 | SERVIER | 05/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf#page=34 |
Tikosyn | Dofetilide | CAPSULE;ORAL | 020931 | PFIZER | 08/08/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020931s017lbl.pdf#page=27 |
Tivdak | Tisotumab Vedotin-Tftv | INJECTABLE;INJECTION | 761208 | SEAGEN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761208Orig1s000lbledt.pdf#page=21 |
Tivorbex | Indomethacin | CAPSULE;ORAL | 204768 | GENUS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204768s008lbl.pdf#page=25 |
Tofranil | 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 |
Tofranil-Pm | Imipramine Pamoate | CAPSULE;ORAL | 017090 | SPECGX LLC | 07/28/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326090.pdf |
Tolectin | Tolmetin Sodium | TABLET;ORAL | 017628 | ORTHO MCNEIL JANSSEN | 01/22/2008 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf |
Tolectin 600 | Tolmetin Sodium | TABLET;ORAL | 017628 | ORTHO MCNEIL JANSSEN | 01/22/2008 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf |
Tolectin DS | Tolmetin Sodium | CAPSULE;ORAL | 018084 | ORTHO MCNEIL JANSSEN | 01/22/2008 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf |
Topamax | Topiramate | CAPSULE;ORAL | 020844 | JANSSEN PHARMS | 01/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf#page=54 |
Topamax | Topiramate | TABLET;ORAL | 020505 | JANSSEN PHARMS | 01/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf#page=54 |
Topamax Sprinkle | Topiramate | CAPSULE;ORAL | 020844 | JANSSEN PHARMS | 01/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf#page=54 |
Toradol | Ketorolac Tromethamine | TABLET;ORAL | 019645 | ROCHE PALO | 03/26/2013 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf#page=23 |
Tracleer | Bosentan | TABLET;ORAL | 021290 | ACTELION | 05/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf#page=30 |
Tracleer | Bosentan | TABLET, FOR SUSPENSION;ORAL | 209279 | ACTELION | 05/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf#page=30 |
Tradjenta | Linagliptin | TABLET;ORAL | 201280 | BOEHRINGER INGELHEIM | 04/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201280s025lbl.pdf#page=16 |
Transderm Scop | Scopolamine | SYSTEM;TRANSDERMAL | 017874 | BAXTER HLTHCARE CORP | 03/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf#page=20 |
Tranxene | Clorazepate Dipotassium | CAPSULE;ORAL | 017105 | RECORDATI RARE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf#page=14 |
Tranxene | Clorazepate Dipotassium | TABLET;ORAL | 017105 | RECORDATI RARE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf#page=14 |
Tranxene SD | Clorazepate Dipotassium | TABLET;ORAL | 017105 | RECORDATI RARE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf#page=14 |
Trazodone Hydrochloride | Trazodone Hydrochloride | TABLET;ORAL | 071196 | APOTEX INC | 04/20/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf#page=3 |
Trelegy Ellipta | Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | POWDER;INHALATION | 209482 | GLAXOSMITHKLINE | 09/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf#page=33 |
Tremfya | Guselkumab | INJECTABLE;INJECTION | 761061 | JANSSEN BIOTECH | 07/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf#page=15 |
Treximet | Naproxen Sodium; Sumatriptan Succinate | TABLET;ORAL | 021926 | CURRAX | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf#page=32 |
Tridione | Trimethadione | SOLUTION;ORAL | 005856 | ABBVIE | 06/07/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf |
Tridione | Trimethadione | CAPSULE;ORAL | 005856 | ABBVIE | 06/07/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf |
Tridione | Trimethadione | TABLET;ORAL | 005856 | ABBVIE | 06/07/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf |
Trijardy XR | Empagliflozin; Linagliptin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614 | BOEHRINGER INGELHEIM | 06/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf#page=42 |
Trileptal | Oxcarbazepine | SUSPENSION;ORAL | 021285 | NOVARTIS | 01/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26 |
Trileptal | Oxcarbazepine | TABLET;ORAL | 021014 | NOVARTIS | 01/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26 |
Trintellix | Vortioxetine Hydrobromide | TABLET;ORAL | 204447 | TAKEDA PHARMS USA | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s024lbl.pdf#page=33 |
Triptodur Kit | Triptorelin Pamoate | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 208956 | ARBOR PHARMS LLC | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208956s010lbl.pdf#page=12 |
Triumeq | Abacavir Sulfate; Dolutegravir Sodium; LAmivudine | TABLET;ORAL | 205551 | VIIV HLTHCARE | 10/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf#page=53 |
Triumeq Pd | Abacavir Sulfate; Dolutegravir Sodium; LAmivudine | SUSPENSION;ORAL | 215413 | VIIV HLTHCARE | 10/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551s029,215413s001lbl.pdf#page=53 |
Trizivir | Abacavir Sulfate; LAmivudine; Zidovudine | TABLET;ORAL | 021205 | VIIV HLTHCARE | 02/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf#page=34 |
Trokendi XR | Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635 | SUPERNUS PHARMS | 10/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s030lbl.pdf#page=52 |
Troxyca ER | Naltrexone Hydrochloride; Oxycodone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621 | PFIZER | 05/26/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf#page=32 |
Trudhesa | Dihydroergotamine Mesylate | SPRAY, METERED;NASAL | 213436 | IMPEL NEUROPHARMA | 09/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213436s000lbl.pdf#page=22 |
Trulance | Plecanatide | TABLET;ORAL | 208745 | SALIX | 04/13/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf#page=15 |
Trulicity | Dulaglutide | INJECTABLE;INJECTION | 125469 | ELI LILLY AND CO | 11/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf#page=16 |
Truvada | Emtricitabine; Tenofovir Disoproxil Fumarate | TABLET;ORAL | 021752 | GILEAD | 06/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf#page=35 |
Truxima | Rituximab-Abbs | INJECTABLE;INJECTION | 761088 | CELLTRION INC | 02/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf#page=49 |
Turalio | Pexidartinib Hydrochloride | CAPSULE;ORAL | 211810 | DAIICHI SANKYO INC | 10/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf#page=20 |
Tussionex Pennkinetic | Chlorpheniramine Polistirex; Hydrocodone Polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 019111 | UCB INC | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf#page=25 |
Tuxarin ER | Chlorpheniramine Maleate; Codeine Phosphate | TABLET, EXTENDED RELEASE;ORAL | 206323 | MAINPOINTE | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf#page=28 |
Tuzistra XR | Chlorpheniramine Polistirex; Codeine Polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 207768 | AYTU | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf#page=27 |
Tymlos | Abaloparatide | SOLUTION;SUBCUTANEOUS | 208743 | RADIUS HEALTH INC | 12/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf#page=18 |
Tysabri | Natalizumab | VIAL; SINGLE-USE | 125104 | BIOGEN IDEC | 12/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125104s973s975lbl.pdf#page=32 |
Tyzeka | Telbivudine | SOLUTION;ORAL | 022154 | NOVARTIS | 12/27/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf#page=19 |
Tyzeka | Telbivudine | TABLET;ORAL | 022011 | NOVARTIS | 12/27/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf#page=19 |
Ukoniq | Umbralisib Tosylate | TABLET;ORAL | 213176 | TG THERAPS | 02/05/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf#page=19 |
Uloric | Febuxostat | TABLET;ORAL | 021856 | TAKEDA PHARMS USA | 02/21/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021856s013lbl.pdf#page=19 |
Ultomiris | Ravulizumab-Cwvz | INJECTABLE;INJECTION | 761108 | ALEXION PHARM | 04/27/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s023lbl.pdf#page=41 |
Ultracet | Acetaminophen; Tramadol Hydrochloride | TABLET;ORAL | 021123 | JANSSEN PHARMS | 09/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021123s021lbl.pdf#page=46 |
Ultram | Tramadol Hydrochloride | TABLET;ORAL | 020281 | JANSSEN PHARMS | 09/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s049lbl.pdf#page=43 |
Ultram ER | Tramadol Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692 | VALEANT PHARMS | 08/29/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf#page=36 |
Uplizna | Inebilizumab-Cdon | INJECTABLE;INJECTION | 761142 | VIELA BIO | 06/11/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761142s000lbl.pdf#page=17 |
Valchlor | Mechlorethamine Hydrochloride | GEL;TOPICAL | 202317 | HELSINN | 05/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s009lbl.pdf#page=10 |
Valium | Diazepam | TABLET;ORAL | 013263 | ROCHE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263s097lbl.pdf#page=15 |
Valtoco | Diazepam | SPRAY;NASAL | 211635 | NEURELIS INC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211635s008lbl.pdf#page=24 |
Vantrela ER | Hydrocodone Bitartrate | TABLET, EXTENDED RELEASE;ORAL | 207975 | TEVA BRANDED PHARM | 05/26/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207975s000lbl.pdf#page=39 |
Venbysi XR | Venlafaxine Besylate | TABLET, EXTENDED RELEASE; ORAL | 215429 | ALMATICA | 06/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215429s000lbl.pdf#page=31 |
Venclexta | Venetoclax | TABLET;ORAL | 208573 | ABBVIE INC | 10/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s026lbl.pdf#page=54 |
Venlafaxine Hydrochloride | Venlafaxine Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104 | OSMOTICA PHARM | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022104s021lbl.pdf#page=35 |
Vibativ | Telavancin Hydrochloride | POWDER;INTRAVENOUS | 022110 | CUMBERLAND PHARMS | 05/06/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf |
Vibativ | Telavancin | INJECTABLE; INJECTION | 022407 | THERAVANCE INC | 06/21/2013 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf |
Viberzi | Eluxadoline | TABLET;ORAL | 206940 | ALLERGAN HOLDINGS | 06/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206940s007lbl.pdf#page=20 |
Vicoprofen | Hydrocodone Bitartrate; Ibuprofen | TABLET;ORAL | 020716 | ABBVIE | 12/16/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf#page=36 |
Victoza | Liraglutide Recombinant | SOLUTION;SUBCUTANEOUS | 022341 | NOVO NORDISK INC | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf#page=31 |
Victrelis | Boceprevir | CAPSULE;ORAL | 202258 | MERCK SHARP DOHME | 01/30/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202258MG.pdf#page=27 |
Videx | Didanosine | FOR SOLUTION;ORAL | 020156 | BRISTOL-MYERS SQUIBB | 12/17/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf#page=34 |
Videx EC | Didanosine | CAPSULE, DELAYED REL PELLETS;ORAL | 021183 | BRISTOL MYERS SQUIBB | 12/17/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s029lbl.pdf#page=33 |
Viekira Pak (Copackaged) | Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir | TABLET;ORAL | 206619 | ABBVIE INC | 12/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206619s020lbl.pdf#page=49 |
Viekira XR | Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir | TABLET, EXTENDED RELEASE;ORAL | 208624 | ABBVIE INC | 12/06/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208624s008lbl.pdf#page=49 |
Viibryd | Vilazodone Hydrochloride | TABLET;ORAL | 022567 | ALLERGAN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022567s022lbl.pdf#page=17 |
Vimovo | Esomeprazole Magnesium; Naproxen | TABLET, DELAYED RELEASE;ORAL | 022511 | HORIZON | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022511s028lbl.pdf#page=40 |
Vimpat | Lacosamide | TABLET;ORAL | 022253 | UCB INC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf#page=30 |
Vimpat | Lacosamide | SOLUTION;INTRAVENOUS | 022254 | UCB INC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf#page=30 |
Vimpat | Lacosamide | SOLUTION;ORAL | 022255 | UCB INC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf#page=30 |
Viokace | Pancrelipase (Amylase;Lipase;Protease) | TABLET;ORAL | 022542 | VIOKACE | 09/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542s007lbl.pdf#page=12 |
Viramune | Nevirapine | SUSPENSION;ORAL | 020933 | BOEHRINGER INGELHEIM | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf#page=19 |
Viramune | Nevirapine | TABLET;ORAL | 020636 | BOEHRINGER INGELHEIM | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf#page=19 |
Viramune XR | Nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152 | BOEHRINGER INGELHEIM | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf#page=18 |
Visicol | Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | TABLET;ORAL | 021097 | SALIX PHARMS | 03/07/2013 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf#page=11 |
Vituz | Chlorpheniramine Maleate; Hydrocodone Bitartrate | SOLUTION;ORAL | 204307 | PERSION | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf#page=25 |
Vivactil | Protriptyline Hydrochloride | TABLET;ORAL | 016012 | TEVA WOMENS | 07/17/2014 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Vivactil.pdf |
Vivitrol | Naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897 | ALKERMES | 05/06/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021897s052lbl.pdf#page=33 |
Vivlodex | Meloxicam | CAPSULE;ORAL | 207233 | ZYLA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207233s004lbl.pdf#page=24 |
Vogelxo | Testosterone | GEL;TRANSDERMAL | 204399 | UPSHER SMITH LABS | 04/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf#page=23 |
Vogelxo | Testosterone | GEL, METERED;TRANSDERMAL | 204399 | UPSHER SMITH LABS | 04/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf#page=23 |
Voltaren | Diclofenac Sodium | TABLET, DELAYED RELEASE;ORAL | 019201 | NOVARTIS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019201s048lbl.pdf#page=18 |
Voltaren Arthritis Pain | Diclofenac Sodium | GEL;TOPICAL | 022122 | GLAXOSMITHKLINE CONS | 11/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf#page=22 |
Voltaren-XR | Diclofenac Sodium | TABLET, EXTENDED RELEASE;ORAL | 020254 | NOVARTIS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf#page=18 |
Votrient | Pazopanib Hydrochloride | TABLET;ORAL | 022465 | NOVARTIS | 09/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf#page=27 |
Vraylar | Cariprazine Hydrochloride | CAPSULE;ORAL | 204370 | ALLERGAN | 05/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf#page=39 |
Vyvanse | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE;ORAL | 208510 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38 |
Vyvanse | Lisdexamfetamine Dimesylate | CAPSULE;ORAL | 021977 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38 |
Wegovy | Semaglutide | SOLUTION;SUBCUTANEOUS | 215256 | NOVO | 12/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf#page=32 |
Welireg | Belzutifan | TABLET;ORAL | 215383 | MERCK SHARP DOHME | 08/13/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf#page=14 |
Wellbutrin | Bupropion Hydrochloride | TABLET;ORAL | 018644 | GLAXOSMITHKLINE | 10/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018644s057lbl.pdf#page=32 |
Wellbutrin SR | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358 | GLAXOSMITHKLINE | 10/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020358s064lbl.pdf#page=34 |
Wellbutrin XL | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021515 | BAUSCH | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021515s044lbl.pdf#page=29 |
Xalkori | Crizotinib | CAPSULE;ORAL | 202570 | PF PRISM CV | 09/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s031lbl.pdf#page=35 |
Xanax | Alprazolam | TABLET;ORAL | 018276 | UPJOHN | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf#page=22 |
Xanax XR | Alprazolam | TABLET, EXTENDED RELEASE;ORAL | 021434 | UPJOHN | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021434s022lbl.pdf#page=23 |
Xarelto | Rivaroxaban | TABLET;ORAL | 022406 | JANSSEN PHARMS | 03/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77 |
Xarelto | Rivaroxaban | TABLET;ORAL | 202439 | JANSSEN PHARMS | 03/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77 |
Xarelto | Rivaroxaban | FOR SUSPENSION;ORAL | 215859 | JANSSEN PHARMS | 12/20/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf#page=77 |
Xartemis XR | Acetaminophen; Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031 | MALLINCKRODT INC | 09/18/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf#page=34 |
Xcopri | Cenobamate | TABLET;ORAL | 212839 | SK LIFE | 06/27/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212839s006s007lbl.pdf#page=25 |
Xeljanz | Tofacitinib Citrate | SOLUTION;ORAL | 213082 | PFIZER | 12/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66 |
Xeljanz | Tofacitinib Citrate | TABLET;ORAL | 203214 | PF PRISM CV | 12/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66 |
Xeljanz XR | Tofacitinib Citrate | TABLET, EXTENDED RELEASE;ORAL | 208246 | PFIZER | 12/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66 |
Xenazine | Tetrabenazine | TABLET;ORAL | 021894 | BAUSCH | 09/13/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf#page=24 |
Xeomin | Incobotulinumtoxina | INJECTABLE;INJECTION | 125360 | MERZ PHARMS | 08/13/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s093lbl.pdf#page=23 |
Xiaflex | Collagenase Clostridium Histolyticum | SOLUTION; INJECTION | 125338 | AUXILIUM PHARMS | 01/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s117lbl.pdf#page=33 |
Xigduo XR | Dapagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649 | ASTRAZENECA AB | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s018lbl.pdf#page=60 |
Xolair | Omalizumab | VIAL | 103976 | GENENTECH | 04/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf#page=36 |
Xospata | Gilteritinib Fumarate | TABLET;ORAL | 211349 | ASTELLAS | 01/12/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf#page=18 |
Xpovio | Selinexor | TABLET;ORAL | 212306 | KARYOPHARM THERAPS | 03/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s010lbl.pdf#page=31 |
Xtampza ER | Oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208090s015lbl.pdf#page=39 |
Xultophy 100/3.6 | Insulin Degludec; Liraglutide | SOLUTION;SUBCUTANEOUS | 208583 | NOVO | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf#page=40 |
Xyosted (Autoinjector) | Testosterone Enanthate | SOLUTION;SUBCUTANEOUS | 209863 | ANTARES PHARMA INC | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf#page=16 |
Xyrem | Sodium Oxybate | SOLUTION;ORAL | 021196 | JAZZ PHARMS | 08/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021196s040lbl.pdf#page=25 |
Xywav | Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate | SOLUTION;ORAL | 212690 | JAZZ | 08/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212690s010lbl.pdf#page=29 |
Yervoy | Ipilimumab | INJECTABLE; INJECTION | 125377 | BRISTOL MYERS SQUIBB | 11/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf#page=72 |
Yondelis | Trabectedin | POWDER;INTRAVENOUS | 207953 | JANSSEN PRODS | 06/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf#page=20 |
Yosprala | Aspirin; Omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103 | GENUS LIFESCIENCES | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205103s008lbl.pdf#page=29 |
Yusimry | Adalimumab-Aqvh | INJECTABLE;INJECTION | 761216 | COHERUS BIOSCIENCES INC | 12/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf#page=38 |
Zarontin | Ethosuximide | CAPSULE;ORAL | 012380 | PARKE DAVIS | 10/28/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034mg.pdf |
Zegerid | Omeprazole; Sodium Bicarbonate | CAPSULE;ORAL | 021849 | SALIX | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf#page=31 |
Zegerid | Omeprazole; Sodium Bicarbonate | FOR SUSPENSION;ORAL | 021636 | SALIX | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf#page=31 |
Zelboraf | Vemurafenib | TABLET;ORAL | 202429 | HOFFMANN LA ROCHE | 05/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf#page=21 |
Zenpep | Pancrelipase;Lipase;Protease;Amylase | CAPSULE, DELAYED RELEASE;ORAL | 022210 | AIMMUNE | 09/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf#page=14 |
Zenpep | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022210 | ZENPEP | 03/20/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf |
Zeposia | Ozanimod Hydrochloride | CAPSULE;ORAL | 209899 | CELGENE INTL | 09/29/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209899s005lbl.pdf#page=25 |
Zerit | Stavudine | FOR SOLUTION;ORAL | 020413 | BRISTOL-MYERS SQUIBB | 12/17/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf#page=29 |
Ziagen | Abacavir Sulfate | SOLUTION;ORAL | 020978 | VIIV HLTHCARE | 11/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020977s035,020978s038lbl.pdf#page=27 |
Zinbryta | Daclizumab | INJECTABLE;INJECTION | 761029 | BIOGEN | 11/01/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf#page=24 |
Zipsor | Diclofenac Potassium | CAPSULE;ORAL | 022202 | ASSERTIO | 05/25/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243355.pdf |
Zohydro ER | Hydrocodone Bitartrate | CAPSULE, EXTENDED RELEASE;ORAL | 202880 | RECRO GAINESVILLE | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202880s020lbl.pdf#page=30 |
Zoloft | Sertraline Hydrochloride | CONCENTRATE;ORAL | 020990 | UPJOHN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf#page=27 |
Zoloft | Sertraline Hydrochloride | TABLET;ORAL | 019839 | UPJOHN | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf#page=27 |
Zolpidem Tartrate | Zolpidem Tartrate | TABLET;ORAL | 076062 | STRIDES PHARMA | 04/23/2007 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Zolpidem.pdf |
Zolpimist | Zolpidem Tartrate | SPRAY, METERED;ORAL | 022196 | AYTU | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s012lbl.pdf#page=19 |
Zonegran | Zonisamide | CAPSULE;ORAL | 020789 | CONCORDIA | 04/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf#page=25 |
Zonisade | Zonisamide | SUSPENSION;ORAL | 214273 | AZURITY | 07/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214273s000lbl.pdf#page=27 |
Zontivity | Vorapaxar Sulfate | TABLET;ORAL | 204886 | XSPIRE PHARMA | 11/07/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf |
Zortress | Everolimus | TABLET;ORAL | 021560 | NOVARTIS | 08/10/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf#page=32 |
Zorvolex | Diclofenac | CAPSULE;ORAL | 204592 | ZYLA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204592s013lbl.pdf#page=26 |
Ztalmy | Ganaxolone | SUSPENSION;ORAL | 215904 | MARINUS PHARMACEUTICALS | 11/09/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215904s001s002lbl.pdf#page=15 |
Zubsolv | Buprenorphine Hydrochloride; Naloxone Hydrochloride | TABLET;SUBLINGUAL | 204242 | OREXO US INC | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf#page=20 |
Zulresso | Brexanolone | SOLUTION;INTRAVENOUS | 211371 | SAGE THERAP | 06/16/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211371s007lbl.pdf#page=20 |
Zurampic | Lesinurad | TABLET;ORAL | 207988 | IRONWOOD PHARMS INC | 08/04/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf#page=17 |
Zutripro | Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | SOLUTION;ORAL | 022439 | PERSION | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022439s010lbl.pdf#page=28 |
Zyban | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711 | GLAXOSMITHKLINE | 03/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020711s052lbl.pdf#page=38 |
Zydelig | Idelalisib | TABLET;ORAL | 205858 | GILEAD SCIENCES INC | 02/18/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205858s016lbl.pdf#page=25 |
Zyprexa | Olanzapine | TABLET;ORAL | 020592 | LILLY | 04/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf#page=37 |
Zyprexa | Olanzapine | INJECTABLE;INTRAMUSCULAR | 021253 | LILLY | 04/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf#page=37 |
Zyprexa Relprevv | Olanzapine Pamoate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022173 | ELI LILLY CO | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s036lbl.pdf#page=29 |
Zyprexa Zydis | Olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086 | LILLY | 04/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf#page=37 |