Medication Guides

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Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events (side effects). This database does not include Medication Guides for FDA-approved allergenic or cellular/tissue products (see FDA Online Label Repository or DailyMed for these Medication Guides). More

Click on drug name to view Medication Guide in PDF format.

Drug Name Active Ingredient Form;Route Appl. No. Company Date Link
Drug Name Active Ingredient Form;Route Appl. No. Company Date Link
Abilify Aripiprazole TABLET;ORAL 021436 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf#page=84
Abilify Aripiprazole TABLET;ORAL 021436 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Aripiprazole SOLUTION;ORAL 021713 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf#page=84
Abilify Aripiprazole SOLUTION;ORAL 021713 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf#page=84
Abilify Aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Aripiprazole INJECTABLE;INTRAMUSCULAR 021866 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021436s043,021713s034,021729s026,021866s028lbl.pdf#page=84
Abilify Aripiprazole INJECTABLE;INTRAMUSCULAR 021866 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Maintena Kit Aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 OTSUKA PHARM CO LTD 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf#page=52
Abilify Mycite Kit Aripiprazole TABLET;ORAL 207202 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s002s004lbl.pdf#page=48
Abrilada Adalimumab-Afzb INJECTABLE;INJECTION 761118 PFIZER INC 11/15/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761118s000lbl.pdf#page=39
Absorica Isotretinoin CAPSULE;ORAL 021951 SUN PHARM INDS INC 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf#page=32
Abstral Fentanyl Citrate TABLET;SUBLINGUAL 022510 SENTYNL THERAPS INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf#page=29
Accutane Isotretinoin CAPSULE;ORAL 018662 HOFFMANN LA ROCHE 10/22/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedGuide.pdf
Aciphex Rabeprazole Sodium TABLET, DELAYED RELEASE;ORAL 020973 EISAI INC 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020973s041lbl.pdf#page=34
Aciphex Sprinkle Rabeprazole Sodium CAPSULE, DELAYED RELEASE;ORAL 204736 AYTU 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf#page=21
Actemra Tocilizumab INJECTABLE; INJECTION 125276 GENENTECH 05/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf#page=46
Actemra Tocilizumab INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 125472 GENENTECH 05/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf#page=46
Actiq Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747 CEPHALON 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020747s049lbl.pdf#page=21
Actonel Risedronate Sodium TABLET;ORAL 020835 APIL 11/05/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf#page=38
Actonel Risedronate Sodium TABLET;ORAL 020835 APIL 11/05/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020835s052lbl.pdf#page=38
Actonel With Calcium (Copackaged) Calcium Carbonate; Risedronate Sodium TABLET, TABLET;ORAL 021823 WARNER CHILCOTT 04/08/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf#page=27
Actoplus MET Metformin Hydrochloride; Pioglitazone Hydrochloride TABLET;ORAL 021842 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf#page=41
Actoplus MET XR Metformin Hydrochloride; Pioglitazone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf#page=41
Actos Pioglitazone Hydrochloride TABLET;ORAL 021073 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35
Adasuve Loxapine POWDER;INHALATION 022549 ALEXZA PHARMS 02/23/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf#page=26
Adderall 10 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 12.5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 15 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 20 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 30 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 7.5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall XR 10 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 15 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 20 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 25 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 30 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Addyi Flibanserin TABLET;ORAL 022526 SPROUT PHARMS 10/09/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf#page=23
Adempas Riociguat TABLET;ORAL 204819 BAYER HLTHCARE 11/30/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf#page=24
Adhansia XR Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038 PURDUE PHARMA LP 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf#page=24
Adlyxin Lixisenatide SOLUTION;SUBCUTANEOUS 208471 SANOFI-AVENTIS US 07/27/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf#page=31
Adzenys ER Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325 NEOS THERAPS INC 09/15/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf#page=26
Ambien Zolpidem Tartrate TABLET;ORAL 019908 SANOFI AVENTIS US 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf#page=23
Ambien CR Zolpidem Tartrate TABLET, EXTENDED RELEASE;ORAL 021774 SANOFI AVENTIS US 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf#page=26
Amjevita Adalimumab-Atto INJECTABLE;INJECTION 761024 AMGEN INC 06/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761024s004lbl.pdf#page=39
Ampyra Dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250 ACORDA 12/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf#page=15
Ampyra Dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250 ACORDA 12/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/22250s017lbl.pdf#page=14
Anafranil Clomipramine Hydrochloride CAPSULE;ORAL 019906 SPECGX LLC 05/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019906s043lbl.pdf#page=27
Anaprox Naproxen Sodium TABLET;ORAL 018164 ATNAHS PHARMA US 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22
Anaprox DS Naproxen Sodium TABLET;ORAL 018164 ATNAHS PHARMA US 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22
Androgel Testosterone GEL, METERED;TRANSDERMAL 021015 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf#page=23
Androgel Testosterone GEL;TRANSDERMAL 021015 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf#page=23
Androgel Testosterone GEL, METERED;TRANSDERMAL 022309 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf#page=25
Androgel Testosterone GEL;TRANSDERMAL 022309 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf#page=25
Ansaid Flurbiprofen TABLET;ORAL 018766 PHARMACIA AND UPJOHN 05/09/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf
Apadaz Acetaminophen; Benzhydrocodone Hydrochloride TABLET;ORAL 208653 KVK TECH INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208653s005lbl.pdf#page=37
Aplenzin Bupropion Hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108 VALEANT PHARMS NORTH 05/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf#page=28
Aplenzin Bupropion Hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108 VALEANT PHARMS NORTH 05/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022108s020lbl.pdf#page=28
Aptensio XR Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 RHODES PHARMS 06/14/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205831s005lbl.pdf#page=22
Aptiom Eslicarbazepine Acetate TABLET;ORAL 022416 SUNOVION PHARMS INC 03/15/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022416s011lbl.pdf#page=25
Aranesp Darbepoetin Alfa VIAL; INTRAVENOUS 103951 AMGEN 01/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25
Aranesp Darbepoetin Alfa VIAL; SUBCUTANEOUS 103951 AMGEN 01/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25
Arcapta Neohaler Indacaterol Maleate POWDER;INHALATION 022383 NOVARTIS 05/29/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf
Arikayce Kit Amikacin Sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356 INSMED INC 10/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf#page=15
Aristada Aripiprazole LAuroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533 ALKERMES INC 08/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf#page=35
Aristada Aripiprazole LAuroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533 ALKERMES INC 08/27/2020 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 08/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=72
Arthrotec Diclofenac Sodium; Misoprostol TABLET, DELAYED RELEASE;ORAL 020607 PFIZER 09/24/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085919.pdf
Arthrotec Diclofenac Sodium; Misoprostol TABLET, DELAYED RELEASE;ORAL 020607 PFIZER 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s033lbl.pdf#page=31
Arthrotec Diclofenac Sodium; Misoprostol TABLET, DELAYED RELEASE;ORAL 020607 PFIZER 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020607s036lbl.pdf#page=31
Arymo ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 208603 ZYLA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf#page=34
Arzerra Ofatumumab INJECTABLE; INJECTION 125326 NOVARTIS 08/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf#page=13
Astagraf XL Tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096 ASTELLAS 06/11/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204096s007lbl.pdf#page=38
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 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf#page=9
Aubagio Teriflunomide TABLET;ORAL 202992 SANOFI AVENTIS US 11/06/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf#page=25
Austedo Deutetrabenazine TABLET;ORAL 208082 TEVA BRANDED PHARM 12/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208082s004lbl.pdf#page=25
Austedo Deutetrabenazine TABLET;ORAL 208082 TEVA BRANDED PHARM 12/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208082s007lbl.pdf#page=25
Avandamet Metformin Hydrochloride; Rosiglitazone Maleate TABLET;ORAL 021410 SB PHARMCO 04/05/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf#page=38
Avandaryl Glimepiride; Rosiglitazone Maleate TABLET;ORAL 021700 SB PHARMCO 12/16/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf#page=39
Avandia Rosiglitazone Maleate TABLET;ORAL 021071 SB PHARMCO 02/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf#page=38
Aveed Testosterone Undecanoate INJECTABLE;INTRAMUSCULAR 022219 ENDO PHARMS INC 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf#page=23
Avelox Moxifloxacin Hydrochloride TABLET;ORAL 021085 BAYER HLTHCARE 05/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33
Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 021277 BAYER HLTHCARE 05/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021085s065,021277s061lbl.pdf#page=33
Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 021277 BAYER HLTHCARE 05/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33
Avinza Morphine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260 KING PHARMS LLC 06/26/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311346.pdf
Avonex Interferon Beta-1a VIAL 103628 BIOGEN 03/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103628s5264lbl.pdf#page=21
Avsola Infliximab-Axxq INJECTABLE;INJECTION 761086 AMGEN INC 12/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761086s000lbl.pdf#page=48
Axiron Testosterone SOLUTION, METERED;TRANSDERMAL 022504 ELI LILLY AND CO 07/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf#page=15
Banzel Rufinamide TABLET;ORAL 021911 EISAI INC 11/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19
Banzel Rufinamide SUSPENSION;ORAL 201367 EISAI INC 11/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19
Bavencio Avelumab INJECTABLE;INJECTION 761049 EMD SERONO INC 11/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf#page=36
Bavencio Avelumab INJECTABLE;INJECTION 761049 EMD SERONO INC 11/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf#page=36
Bavencio Avelumab INJECTABLE;INTRAVENOUS 761078 EMD SERONO INC 05/09/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf#page=23
Baxdela Delafloxacin Meglumine TABLET;ORAL 208610 MELINTA 10/24/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf#page=23
Baxdela Delafloxacin Meglumine TABLET;ORAL 208610 MELINTA 10/24/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28
Baxdela Delafloxacin Meglumine POWDER;INTRAVENOUS 208611 MELINTA 10/24/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s006,208611s005lbl.pdf#page=23
Baxdela Delafloxacin Meglumine POWDER;INTRAVENOUS 208611 MELINTA 10/24/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28
Belbuca Buprenorphine Hydrochloride FILM;BUCCAL 207932 BDSI 10/16/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf#page=28
Belbuca Buprenorphine Hydrochloride FILM;BUCCAL 207932 BDSI 10/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207932s012lbl.pdf#page=37
Belsomra Suvorexant TABLET;ORAL 204569 MERCK SHARP DOHME 03/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf#page=22
Belsomra Suvorexant TABLET;ORAL 204569 MERCK SHARP DOHME 03/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569Orig1s007lbl.pdf#page=23
Belsomra Suvorexant TABLET;ORAL 204569 MERCK SHARP DOHME 03/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204569s006lbl.pdf#page23
Benlysta Belimumab INJECTABLE; INJECTION 125370 HUMAN GENOME SCIENCES INC. 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf#page=33
Benlysta Belimumab INJECTABLE;INJECTION 761043 GLAXOSMITHKLINE LLC 01/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf#page=33
Betaseron Interferon Beta-1b VIAL; SUBCUTANEOUS 103471 BAYER HEALTHCARE PHARMS 10/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf#page=18
Bevyxxa Betrixaban CAPSULE;ORAL 208383 PORTOLA PHARMS INC 08/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20
Binosto Alendronate Sodium TABLET, EFFERVESCENT;ORAL 202344 ASCEND THERAPS US 10/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf#page=33
Blenrep Belantamab Mafodotin-Blmf INJECTABLE;INTRAVENOUS 761158 GLAXOSMITHKLINE 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf#page=21
Blincyto Blinatumomab INJECTABLE;INJECTION 125557 AMGEN 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf#page=33
Boniva Ibandronate Sodium TABLET;ORAL 021455 HOFFMANN LA ROCHE 12/07/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf#page=19
Boniva Ibandronate Sodium INJECTABLE;INTRAVENOUS 021858 ROCHE 12/07/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18
Bonsity Teriparatide SOLUTION;SUBCUTANEOUS 211939 ALVOGEN 10/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211939s000lbl.pdf#page=25
Botox Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 09/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000Orig1s5315lbl.pdf#page=47
Botox Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 09/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000s5317lbl.pdf#page=47
Botox Cosmetic Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 09/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000Orig1s5315lbl.pdf#page=47
Botox Cosmetic Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 09/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103000s5317lbl.pdf#page=47
Braftovi Encorafenib CAPSULE;ORAL 210496 ARRAY BIOPHARMA INC 04/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210496s003lbl.pdf#page=18
Brilinta Ticagrelor TABLET;ORAL 022433 ASTRAZENECA PHARMS 11/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s029lbl.pdf#page=34
Brilinta Ticagrelor TABLET;ORAL 022433 ASTRAZENECA PHARMS 11/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf#page=29
Brisdelle Paroxetine Mesylate CAPSULE;ORAL 204516 SEBELA IRELAND LTD 04/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf#page=22
Briviact Brivaracetam TABLET;ORAL 205836 UCB INC 05/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17
Briviact Brivaracetam SOLUTION;INTRAVENOUS 205837 UCB INC 05/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17
Briviact Brivaracetam SOLUTION;ORAL 205838 UCB INC 05/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17
Brovana Arformoterol Tartrate SOLUTION;INHALATION 021912 SUNOVION 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf#page=22
Bunavail Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL 205637 BDSI 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205637s020lbl.pdf#page=31
Butrans Buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 PURDUE PHARMA LP 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021306s035lbl.pdf#page=42
Bydureon Exenatide Synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 ASTRAZENECA AB 02/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf#page=31
Bydureon Bcise Exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 ASTRAZENECA AB 12/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209210s002s003s004s005s006s007s008lbl.pdf#page=32
Bydureon Bcise Exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 ASTRAZENECA AB 12/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s011lbl.pdf#page=33
Bydureon Bcise Exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 ASTRAZENECA AB 12/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209210s014lbl.pdf#page=33
Bydureon Pen Exenatide Synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 ASTRAZENECA AB 02/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf#page=31
Byetta Exenatide Synthetic INJECTABLE;SUBCUTANEOUS 021773 ASTRAZENECA AB 02/28/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf
Byetta Exenatide Synthetic INJECTABLE;SUBCUTANEOUS 021773 ASTRAZENECA AB 02/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021773s041lbl.pdf#page=32
Byetta Exenatide Synthetic INJECTABLE;SUBCUTANEOUS 021773 ASTRAZENECA AB 02/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf#page=35
Byetta Exenatide Synthetic INJECTABLE; SUBCUTANEOUS 021919 AMYLIN 10/30/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf
Cambia Diclofenac Potassium FOR SOLUTION;ORAL 022165 ASSERTIO 03/20/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM169077.pdf
Cambia Diclofenac Potassium FOR SOLUTION;ORAL 022165 ASSERTIO 03/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf#page=19
Campath Alemtuzumab VIAL; INTRAVENOUS 103948 GENZYME 10/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf#page=30
Caprelsa Vandetanib TABLET;ORAL 022405 GENZYME CORP 06/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s017lbl.pdf#page=20
Carbatrol Carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712 TAKEDA PHARMS USA 08/26/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf
Cassipa Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;SUBLINGUAL 208042 TEVA PHARMS USA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208042s001lbl.pdf#page=27
Cataflam Diclofenac Potassium TABLET;ORAL 020142 NOVARTIS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135935.pdf
Celebrex Celecoxib CAPSULE;ORAL 020998 GD SEARLE 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020998s054lbl.pdf#page=21
Celebrex Celecoxib CAPSULE;ORAL 021156 GD SEARLE LLC 02/04/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003MedG.pdf
Celexa Citalopram Hydrobromide TABLET;ORAL 020822 ALLERGAN 01/11/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf#page=33
Celexa Citalopram Hydrobromide SOLUTION;ORAL 021046 FOREST LABS 12/03/2012 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088568.pdf
Cellcept Mycophenolate Mofetil CAPSULE;ORAL 050722 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cellcept Mycophenolate Mofetil CAPSULE;ORAL 050722 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38
Cellcept Mycophenolate Mofetil TABLET;ORAL 050723 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cellcept Mycophenolate Mofetil TABLET;ORAL 050723 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38
Cellcept Mycophenolate Mofetil Hydrochloride INJECTABLE;INJECTION 050758 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cellcept Mycophenolate Mofetil Hydrochloride INJECTABLE;INJECTION 050758 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38
Cellcept Mycophenolate Mofetil SUSPENSION;ORAL 050759 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cellcept Mycophenolate Mofetil SUSPENSION;ORAL 050759 ROCHE PALO 12/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38
Celontin Methsuximide CAPSULE;ORAL 010596 PARKE DAVIS 06/15/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf
Cerdelga Eliglustat Tartrate CAPSULE;ORAL 205494 GENZYME CORP 08/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494Orig1s000lbl.pdf
Cerdelga Eliglustat Tartrate CAPSULE;ORAL 205494 GENZYME CORP 08/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf#page=19
Chantix Varenicline Tartrate TABLET;ORAL 021928 PF PRISM CV 02/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22
Children's Cetirizine Hydrochloride Allergy Cetirizine Hydrochloride SYRUP;ORAL 212266 QUAGEN 05/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf#page=14
Chlordiazepoxide and Amitriptyline Hydrochloride Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 071297 MYLAN PHARMS INC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf
Cimzia Certolizumab Pegol INJECTABLE; INJECTION 125160 UCB INC 09/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf#page=37
Cimzia Certolizumab Pegol INJECTABLE; INJECTION 125160 UCB INC 09/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s237lbl.pdf#page=40
Cimzia Certolizumab Pegol INJECTABLE; INJECTION 125160 UCB INC 09/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s289lbl.pdf#page=39
Cimzia Certolizumab Pegol INJECTABLE; INJECTION 125160 UCB INC 09/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s293lbl.pdf#page=41
Cipro Ciprofloxacin Hydrochloride TABLET;ORAL 019537 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s090,020780s047lbl.pdf#page=39
Cipro Ciprofloxacin Hydrochloride TABLET;ORAL 019537 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s091,020780s048lbl.pdf#page=39
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 05/08/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019847s059lbl.pdf#page=32
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019847s060lbl.pdf#page=32
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s061lbl.pdf#page=33
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019847s062lbl.pdf#page=33
Cipro Ciprofloxacin FOR SUSPENSION;ORAL 020780 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s090,020780s047lbl.pdf#page=39
Cipro Ciprofloxacin FOR SUSPENSION;ORAL 020780 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s091,020780s048lbl.pdf#page=39
Cipro in Dextrose 5% in Plastic Container Ciprofloxacin INJECTABLE;INJECTION 019857 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019857s066lbl.pdf#page=33
Cipro in Dextrose 5% in Plastic Container Ciprofloxacin INJECTABLE;INJECTION 019857 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019857s070lbl.pdf#page=33
Cipro in Dextrose 5% in Plastic Container Ciprofloxacin INJECTABLE;INJECTION 019857 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019857s072lbl.pdf#page=33
Cipro XR Ciprofloxacin; Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021473s041lbl.pdf#page=29
Cipro XR Ciprofloxacin; Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 BAYER HLTHCARE 05/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021473s042lbl.pdf#page=30
Clenpiq Citric Acid; Magnesium Oxide; Sodium Picosulfate SOLUTION;ORAL 209589 FERRING PHARMS INC 10/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf#page=14
Clinoril Sulindac TABLET;ORAL 017911 MERCK 12/23/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf
Codeine Sulfate Codeine Sulfate TABLET;ORAL 022402 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf#page=29
Codeine Sulfate Codeine Sulfate SOLUTION;ORAL 202245 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf#page=26
Codeine Sulfate Codeine Sulfate SOLUTION;ORAL 202245 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf#page=27
Codeine Sulfate Codeine Sulfate SOLUTION;ORAL 202245 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202245s008lbl.pdf#page=28
Colcrys Colchicine TABLET;ORAL 022352 TAKEDA PHARMS USA 05/14/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf#page=24
Colcrys Colchicine TABLET;ORAL 022352 TAKEDA PHARMS USA 05/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf#page=25
Colcrys Colchicine TABLET; ORAL 022353 AR HOLDING CO INC 10/16/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf
Combunox Ibuprofen; Oxycodone Hydrochloride TABLET;ORAL 021378 FOREST LABS 09/02/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088574.pdf
Concerta Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 JANSSEN PHARMS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf#page=30
Contrave Bupropion Hydrochloride; Naltrexone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063 NALPROPION 08/04/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf#page=39
Contrave Bupropion Hydrochloride; Naltrexone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063 NALPROPION 08/04/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200063s015lbl.pdf#page=40
Conzip Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022370 CIPHER PHARMS INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022370s018lbl.pdf#page=34
Copegus Ribavirin TABLET;ORAL 021511 ROCHE 08/11/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf#page=27
Cordarone Amiodarone Hydrochloride TABLET;ORAL 018972 WYETH PHARMS 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf#page=22
Cordarone Amiodarone Hydrochloride TABLET;ORAL 018972 WYETH PHARMS 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf#page=13
Corlanor Ivabradine Hydrochloride TABLET;ORAL 206143 AMGEN INC 05/13/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf#page=20
Corlanor Ivabradine Hydrochloride TABLET;ORAL 206143 AMGEN INC 05/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206143s007lbl.pdf#page=24
Corlanor Ivabradine SOLUTION;ORAL 209964 AMGEN INC 04/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209964lbl.pdf#page=24
Cosentyx Secukinumab INJECTABLE;INJECTION 125504 NOVARTIS PHARMS CORP 06/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf#page=20
Cosentyx Secukinumab INJECTABLE;INJECTION 125504 NOVARTIS PHARMS CORP 06/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf#page=22
Cotempla XR-Odt Methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NEOS THERAPS INC 06/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf#page=21
Coumadin Warfarin Sodium INJECTABLE;INJECTION 009218 BRISTOL MYERS SQUIBB 08/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30
Coumadin Warfarin Sodium TABLET;ORAL 009218 BRISTOL MYERS SQUIBB 08/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30
Creon Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 020725 ABBVIE 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf#page=16
Cyltezo Adalimumab-Adbm INJECTABLE;INJECTION 761058 BOEHRINGER INGELHEIM 09/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761058s003lbl.pdf#page=30
Cymbalta Duloxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 LILLY 10/01/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf#page=32
Cymbalta Duloxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 LILLY 10/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021427s051lbl.pdf#page=33
Cymbalta Duloxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 LILLY 10/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf#page=38
Daliresp Roflumilast TABLET;ORAL 022522 ASTRAZENECA PHARMS 01/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf#page=17
Dalmane Flurazepam Hydrochloride CAPSULE;ORAL 016721 VALEANT PHARM INTL 03/27/2009 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
Darvocet-N 100 Acetaminophen; Propoxyphene Napsylate TABLET;ORAL 017122 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf
Darvocet-N 50 Acetaminophen; Propoxyphene Napsylate TABLET;ORAL 017122 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf
Darvon Propoxyphene Hydrochloride CAPSULE;ORAL 010997 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf
Darvon-N Propoxyphene Napsylate TABLET;ORAL 016862 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf
Daurismo Glasdegib Maleate TABLET;ORAL 210656 PFIZER 03/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf#page=20
Daypro Oxaprozin TABLET;ORAL 018841 PFIZER 05/03/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501638.pdf
Daypro Oxaprozin TABLET;ORAL 018841 PFIZER 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018841s030lbl.pdf#page=24
Daypro Alta Oxaprozin Potassium TABLET;ORAL 020776 PFIZER 05/03/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088580.pdf
Daypro Alta Oxaprozin Potassium TABLET;ORAL 020776 PFIZER 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020776s008lbl.pdf#page=21
Daytrana Methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NOVEN PHARMS INC 10/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s028lbl.pdf#page=23
Dayvigo Lemborexant TABLET;ORAL 212028 EISAI INC 08/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212028s000lbl.pdf#page=21
Demerol Meperidine Hydrochloride INJECTABLE;INJECTION 005010 US PHARM HOLDINGS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30
Demerol Meperidine Hydrochloride SYRUP;ORAL 005010 US PHARM HOLDINGS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30
Demerol Meperidine Hydrochloride TABLET;ORAL 005010 US PHARM HOLDINGS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30
Demerol Meperidine Hydrochloride INJECTABLE;INJECTION 005010 US PHARM HOLDINGS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf#page=31
Demerol Meperidine Hydrochloride SYRUP;ORAL 005010 US PHARM HOLDINGS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf#page=31
Demerol Meperidine Hydrochloride TABLET;ORAL 005010 US PHARM HOLDINGS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005010s058lbl.pdf#page=31
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 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018723s062lbl.pdf#page=48
Depakote Divalproex Sodium TABLET, DELAYED RELEASE;ORAL 018723 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018723s063lbl.pdf#page=48
Depakote Divalproex Sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019680s049lbl.pdf#page=42
Depakote Divalproex Sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019680s050lbl.pdf#page=42
Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE;ORAL 021168 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021168s038lbl.pdf#page=44
Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE;ORAL 021168 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021168s040lbl.pdf#page=47
Descovy Emtricitabine; Tenofovir Alafenamide Fumarate TABLET;ORAL 208215 GILEAD SCIENCES INC 12/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf#page=37
Desoxyn Methamphetamine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378 RECORDATI RARE 04/11/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf#page=12
Desoxyn Methamphetamine Hydrochloride TABLET;ORAL 005378 RECORDATI RARE 04/11/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf#page=12
Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204150 ALEMBIC PHARMS LTD 10/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf#page=30
Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204150 ALEMBIC PHARMS LTD 10/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204150s010lbl.pdf#page=31
Desvenlafaxine Desvenlafaxine Fumarate TABLET, EXTENDED RELEASE;ORAL 205208 TEVA PHARMS USA 07/18/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372058.pdf
Desvenlafaxine Desvenlafaxine Fumarate TABLET, EXTENDED RELEASE;ORAL 205583 SUN PHARMA GLOBAL 12/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205583s010lbl.pdf#page=30
Desyrel Trazodone Hydrochloride TABLET;ORAL 018207 PRAGMA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf#page=13
Desyrel Trazodone Hydrochloride TABLET;ORAL 018207 PRAGMA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf#page=14
Dexedrine Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 IMPAX LABS INC 01/15/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf#page=9
Dexedrine Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 IMPAX LABS INC 01/15/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf#page=11
Dexilant Dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287 TAKEDA PHARMS USA 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022287s034lbl.pdf#page=23
Dextroamphetamine Sulfate Dextroamphetamine Sulfate SOLUTION;ORAL 040776 OUTLOOK PHARMS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088583.pdf
Diacomit Stiripentol CAPSULE;ORAL 206709 BIOCODEX SA 08/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17
Diacomit Stiripentol FOR SUSPENSION;ORAL 207223 BIOCODEX SA 08/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17
Dilantin Phenytoin Sodium CAPSULE;ORAL 084349 UPJOHN 08/07/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/084349s085lbl.pdf#page=19
Dilantin Phenytoin TABLET, CHEWABLE;ORAL 084427 PHARMACIA 12/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf#page=17
Dilantin-125 Phenytoin SUSPENSION;ORAL 008762 UPJOHN 07/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18
Dilantin-30 Phenytoin SUSPENSION;ORAL 008762 UPJOHN 07/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18
Dilaudid Hydromorphone Hydrochloride SOLUTION;ORAL 019891 RHODES PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf#page=28
Dilaudid Hydromorphone Hydrochloride TABLET;ORAL 019892 RHODES PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf#page=28
Dolophine Hydrochloride Methadone Hydrochloride SYRUP;ORAL 006134 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/006134s049lbl.pdf#page=34
Dolophine Hydrochloride Methadone Hydrochloride TABLET;ORAL 006134 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/006134s049lbl.pdf#page=34
Doral Quazepam TABLET;ORAL 018708 GALT PHARMS 02/06/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf#page=12
Doral Quazepam TABLET;ORAL 018708 GALT PHARMS 02/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018708s025lbl.pdf#page=12
Dotarem Gadoterate Meglumine SOLUTION;INTRAVENOUS 204781 GUERBET 07/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s009lbl.pdf#page=29
Dotarem Gadoterate Meglumine SOLUTION;INTRAVENOUS 204781 GUERBET 07/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204781s012lbl.pdf#page=17
Drizalma Sprinkle Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE;ORAL 212516 SUN PHARMA GLOBAL 06/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212516s000lbl.pdf#page=42
Drizalma Sprinkle Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE;ORAL 212516 SUN PHARMA GLOBAL 06/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212516s001lbl.pdf#page=49
Droxia Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 12/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf#page=15
Droxia Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 12/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf#page=27
Duetact Glimepiride; Pioglitazone Hydrochloride TABLET;ORAL 021925 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf#page=39
Duexis Famotidine; Ibuprofen TABLET;ORAL 022519 HORIZON 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf#page=22
Duexis Famotidine; Ibuprofen TABLET;ORAL 022519 HORIZON 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022519s012lbl.pdf#page=23
Duragesic-100 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf#page=50
Duragesic-12 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf#page=50
Duragesic-25 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf#page=50
Duragesic-37 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf#page=50
Duragesic-50 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf#page=50
Duragesic-75 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019813s079lbl.pdf#page=50
Duzallo Allopurinol; Lesinurad TABLET;ORAL 209203 IRONWOOD PHARMS INC 08/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209203s000lbl.pdf#page=27
Dyanavel XR Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147 TRIS PHARMA INC 02/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf#page=15
Dyanavel XR Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147 TRIS PHARMA INC 02/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/ 208147s005lbl.pdf#page=17
Dysport Abobotulinumtoxina INJECTABLE; INJECTION 125274 IPSEN BIOPHARM LTD 07/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125274s115lbl.pdf#page=31
Dysport Abobotulinumtoxina INJECTABLE; INJECTION 125274 IPSEN BIOPHARM LTD 07/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125274Orig1s118lbl.pdf#page=30
EC-Naprosyn Naproxen TABLET, DELAYED RELEASE;ORAL 020067 ATNAHS PHARMA US 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22
Edluar Zolpidem Tartrate TABLET;SUBLINGUAL 021997 MYLAN SPECIALITY LP 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf#page=23
Effexor Venlafaxine Hydrochloride TABLET;ORAL 020151 WYETH PHARMS INC 12/12/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf#page=34
Effexor XR Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699 UPJOHN 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf#page=36
Effient Prasugrel Hydrochloride TABLET;ORAL 022307 DAIICHI SANKYO INC 03/28/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM238428.pdf
Effient Prasugrel Hydrochloride TABLET;ORAL 022307 DAIICHI SANKYO INC 03/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf#page=19
Effient Prasugrel Hydrochloride TABLET;ORAL 022307 DAIICHI SANKYO INC 03/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022307s016lbl.pdf#page=20
Elepsia XR Levetiracetam TABLET, EXTENDED RELEASE;ORAL 204417 SPARC 12/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204417s000lbl.pdf#page=27
Elidel Pimecrolimus CREAM;TOPICAL 021302 BAUSCH 06/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088587.pdf
Eliquis Apixaban TABLET;ORAL 202155 BRISTOL MYERS SQUIBB 11/26/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf#page=40
Eliquis Apixaban TABLET;ORAL 202155 BRISTOL MYERS SQUIBB 11/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s021lbl.pdf#page=41
Eliquis Apixaban TABLET;ORAL 202155 BRISTOL MYERS SQUIBB 11/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202155s024lbl.pdf#page=37
Elyxyb Celecoxib SOLUTION;ORAL 212157 DR REDDYS 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf#page=24
Embeda Morphine Sulfate; Naltrexone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 ALPHARMA PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf#page=28
Embeda Morphine Sulfate; Naltrexone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 ALPHARMA PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf#page=30
Emsam Selegiline FILM, EXTENDED RELEASE;TRANSDERMAL 021336 SOMERSET 07/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf#page=34
Emsam Selegiline SYSTEM; TRANSDERMAL 021708 SOMERSET 02/27/2006 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf
Enbrel Etanercept SYRINGE 103795 IMMUNEX 03/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34
Enbrel Etanercept VIAL; SUBCUTANEOUS 103795 IMMUNEX 03/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34
Enbrel Etanercept SYRINGE 103795 IMMUNEX 03/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34
Enbrel Etanercept VIAL; SUBCUTANEOUS 103795 IMMUNEX 03/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34
Enbrel Etanercept SYRINGE 103795 IMMUNEX 03/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35
Enbrel Etanercept VIAL; SUBCUTANEOUS 103795 IMMUNEX 03/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35
Entyvio Vedolizumab INJECTABLE;INJECTION 125476 TAKEDA PHARMS USA 03/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf#page=20
Entyvio Vedolizumab INJECTABLE;INJECTION 125476 TAKEDA PHARMS USA 03/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125476s024lbl.pdf#page20
Entyvio Vedolizumab INJECTABLE;INJECTION 125476 TAKEDA PHARMS USA 03/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125476s025s030lbl.pdf#page=20
Envarsus XR Tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406 VELOXIS PHARMS INC 09/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206406s007lbl.pdf#page=29
Eovist Gadoxetate Disodium SOLUTION;INTRAVENOUS 022090 BAYER HLTHCARE 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf#page=51
Epidiolex Cannabidiol SOLUTION;ORAL 210365 GW RES LTD 10/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s008lbl.pdf#page=29
Epogen/Procrit Epoetin Alfa VIAL; MULTIDOSE 103234 AMGEN 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27
Epogen/Procrit Epoetin Alfa VIAL; SINGLE-USE 103234 AMGEN 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27
Epzicom Abacavir Sulfate; LAmivudine TABLET;ORAL 021652 VIIV HLTHCARE 05/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf#page=28
Equetro Carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710 VALIDUS PHARMS 09/23/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf#page=22
Erelzi Etanercept-Szzs INJECTABLE; INJECTION 761042 SANDOZ 06/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761042s012lbl.pdf#page=39
Erivedge Vismodegib CAPSULE;ORAL 203388 GENENTECH 07/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf#page=12
Erivedge Vismodegib CAPSULE;ORAL 203388 GENENTECH 07/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s012lbl.pdf#page=13
Erivedge Vismodegib CAPSULE;ORAL 203388 GENENTECH 07/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s014lbl.pdf#page=13
Erivedge Vismodegib CAPSULE;ORAL 203388 GENENTECH 07/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203388s016lbl.pdf#page=14
Esomeprazole Strontium Esomeprazole Strontium CAPSULE, DELAYED RELEASE;ORAL 202342 BELCHER 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202342s006lbl.pdf#page=29
Estazolam Estazolam TABLET;ORAL 074921 MAYNE PHARMA 02/06/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359235.pdf
Eticovo Etanercept-Ykro INJECTABLE;INJECTION 761066 SAMSUNG BIOEPIS CO LTD 04/25/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf#page=31
Evekeo ODT Amphetamine Sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905 ARBOR PHARMS LLC 01/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209905s000lbl.pdf#page=15
Evenity Romosozumab-Aqqg INJECTABLE;INJECTION 761062 AMGEN INC 12/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761062s000lbl.pdf#page=19
Evista Raloxifene Hydrochloride TABLET;ORAL 020815 LILLY 06/27/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
Evista Raloxifene Hydrochloride TABLET; ORAL 022042 LILLY 09/13/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
Exalgo Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217 SPECGX LLC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf#page=31
Exjade Deferasirox TABLET, FOR SUSPENSION;ORAL 021882 NOVARTIS 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021882s033lbl.pdf#page=28
Extavia Interferon Beta-1b INJECTABLE; SUBCUTANEOUS 125290 NOVARTIS PHARMS 10/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125290s070lbl.pdf#page=16
Extraneal Icodextrin SOLUTION;INTRAPERITONEAL 021321 BAXTER HLTHCARE 12/04/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135933.pdf
Factive Gemifloxacin Mesylate TABLET;ORAL 021158 LG CHEM LTD 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf#page=30
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf#page=38
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf#page=47
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.pdf#page=38
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s022lbl.pdf#page=38
Farydak Panobinostat LActate CAPSULE;ORAL 205353 SECURA 06/06/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf
Felbatol Felbamate SUSPENSION;ORAL 020189 MYLAN SPECIALITY LP 08/31/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf
Felbatol Felbamate TABLET;ORAL 020189 MYLAN SPECIALITY LP 08/31/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf
Feldene Piroxicam CAPSULE;ORAL 018147 PFIZER 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf#page=16
Feldene Piroxicam CAPSULE;ORAL 018147 PFIZER 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018147s048lbl.pdf#page=16
Fensolvi Kit Leuprolide Acetate POWDER;SUBCUTANEOUS 213150 TOLMAR 05/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213150s000lbl.pdf#page=15
Fentanyl Citrate Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312 PAR PHARM 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf
Fentanyl Citrate Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907 SPECGX LLC 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf
Fentora Fentanyl Citrate TABLET;BUCCAL, SUBLINGUAL 021947 CEPHALON 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021947s029lbl.pdf#page=20
Ferriprox Deferiprone TABLET;ORAL 021825 CHIESI 02/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021825s004lbl.pdf#page=11
Ferriprox Deferiprone TABLET;ORAL 021825 CHIESI 02/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/ 021825s007lbl.pdf#page=21
Ferriprox Deferiprone SOLUTION;ORAL 208030 CHIESI 02/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf#page=11
Ferriprox Deferiprone SOLUTION;ORAL 208030 CHIESI 02/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208030s004lbl.pdf#page=11
Ferriprox Deferiprone TABLET;ORAL 212269 CHIESI 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212266s000lbl.pdf#page=14
Fetzima Levomilnacipran Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 ALLERGAN 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204168s006lbl.pdf#page=28
Fintepla Fenfluramine Hydrochloride SOLUTION;ORAL 212102 ZOGENIX INC 06/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf#page=23
Fioricet W/ Codeine Acetaminophen; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 020232 ACTAVIS LABS UT INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf#page=41
Fiorinal W/Codeine Aspirin; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 019429 ALLERGAN 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf#page=39
Firdapse Amifampridine Phosphate TABLET;ORAL 208078 CATALYST PHARMS 11/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf#page=11
Flector Diclofenac Epolamine SYSTEM;TOPICAL 021234 INST BIOCHEM 03/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf#page=21
Flector Diclofenac Epolamine SYSTEM;TOPICAL 021234 INST BIOCHEM 03/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021234s016s017lbl.pdf#page=22
Flowtuss Guaifenesin; Hydrocodone Bitartrate SOLUTION;ORAL 022424 BKK PHARMS 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf#page=26
Floxin Ofloxacin TABLET;ORAL 019735 JANSSEN PHARMS 02/25/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf
Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET;ORAL 202133 ALVOGEN 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf#page=40
Focalin Dexmethylphenidate Hydrochloride TABLET;ORAL 021278 NOVARTIS 11/19/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf#page=14
Focalin Dexmethylphenidate Hydrochloride TABLET;ORAL 021278 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s011s019lbl.pdf#page=15
Focalin Dexmethylphenidate Hydrochloride TABLET;ORAL 021278 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021278s026lbl.pdf#page=14
Focalin XR Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NOVARTIS 11/19/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf#page=17
Focalin XR Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s019s029lbl.pdf#page=19
Focalin XR Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021802s036lbl.pdf#page=18
Foradil Formoterol Fumarate POWDER;INHALATION 020831 NOVARTIS 03/02/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf
Foradil Certihaler Formoterol Fumarate POWDER;INHALATION 021592 NOVARTIS 06/02/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088603.pdf
Forfivo XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 ALVOGEN 12/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf#page=32
Forfivo XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 ALVOGEN 12/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022497s008lbl.pdf#page=33
Forteo Teriparatide SOLUTION;SUBCUTANEOUS 021318 LILLY 11/16/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088604.pdf
Fortesta Testosterone GEL, METERED;TRANSDERMAL 021463 ENDO PHARMS 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf#page=21
Fosamax Alendronate Sodium TABLET;ORAL 020560 MERCK AND CO INC 08/16/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf
Fosamax Alendronate Sodium TABLET;ORAL 020560 MERCK AND CO INC 08/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24
Fosamax Alendronate Sodium SOLUTION;ORAL 021575 MERCK 11/30/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf
Fosamax Alendronate Sodium SOLUTION;ORAL 021575 MERCK 11/30/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24
Fosamax Plus D Alendronate Sodium; Cholecalciferol TABLET;ORAL 021762 MERCK 08/16/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf
Fosamax Plus D Alendronate Sodium; Cholecalciferol TABLET;ORAL 021762 MERCK 08/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021762s022lbl.pdf#page=23
Fosrenol Lanthanum Carbonate TABLET, CHEWABLE;ORAL 021468 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf#page=12
Fosrenol Lanthanum Carbonate TABLET, CHEWABLE;ORAL 021468 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf#page=12
Fosrenol Lanthanum Carbonate TABLET, CHEWABLE;ORAL 021468 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf#page=12
Fosrenol Lanthanum Carbonate POWDER;ORAL 204734 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf#page=12
Fosrenol Lanthanum Carbonate POWDER;ORAL 204734 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf#page=12
Fycompa Perampanel TABLET;ORAL 202834 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24
Fycompa Perampanel TABLET;ORAL 202834 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24
Fycompa Perampanel TABLET;ORAL 202834 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf#page=24
Fycompa Perampanel SUSPENSION;ORAL 208277 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24
Fycompa Perampanel SUSPENSION;ORAL 208277 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24
Fycompa Perampanel SUSPENSION;ORAL 208277 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf#page=24
Gabitril Tiagabine Hydrochloride TABLET;ORAL 020646 CEPHALON 08/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229203.pdf
Gadavist Gadobutrol SOLUTION;INTRAVENOUS 201277 BAYER HLTHCARE 07/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201277s018lbl.pdf#page=22
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 07/14/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333533.pdf
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 07/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf#page=10
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 07/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203441s012lbl.pdf#page15
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 07/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203441s013lbl.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 06/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209388s000lbl.pdf#page=17
Gloperba Colchicine SOLUTION;ORAL 210942 AVION PHARMS 01/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210942s000lbl.pdf#page=11
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf#page=31
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf#page=32
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf#page=32
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s021lbl.pdf#page=33
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf#page=33
Golytely Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous FOR SOLUTION;ORAL 019011 BRAINTREE 06/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019011s031lbl.pdf#page=9
Gralise Gabapentin TABLET;ORAL 022544 ALMATICA 04/02/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM245196.pdf
H.P. Acthar Gel Repository Corticotropin INJECTABLE; INJECTION 022432 QUESTCOR PHARMA 10/15/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf
Hadlima Adalimumab-Bwwd INJECTABLE;INJECTION 761059 SAMSUNG BIOEPIS CO LTD 07/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf#page=36
Halcion Triazolam TABLET;ORAL 017892 PHARMACIA AND UPJOHN 10/09/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017892s050lbl.pdf#page=17
Halflytely Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 021551 BRAINTREE 06/03/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM220644.pdf
Hemlibra Emicizumab INJECTABLE;INJECTION 761083 GENENTECH INC 10/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf#page=21
Horizant Gabapentin Enacarbil TABLET, EXTENDED RELEASE;ORAL 022399 ARBOR PHARMS LLC 04/17/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250398.pdf
Horizant Gabapentin Enacarbil TABLET, EXTENDED RELEASE;ORAL 022399 ARBOR PHARMS LLC 04/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s010lbl.pdf#page=27
Hulio Adalimumab-Fkjp INJECTABLE;INJECTION 761154 MYLAN PHARMS INC 07/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf#page=41
Humira Adalimumab SYRINGE 125057 ABBVIE INC 03/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53
Humira Adalimumab VIAL 125057 ABBVIE INC 03/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53
Humira Adalimumab SYRINGE 125057 ABBVIE INC 03/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=56
Humira Adalimumab VIAL 125057 ABBVIE INC 03/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=56
Hycodan Homatropine METhylbromide; Hydrocodone Bitartrate SYRUP;ORAL 005213 GENUS 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27
Hycodan Homatropine METhylbromide; Hydrocodone Bitartrate TABLET;ORAL 005213 GENUS 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27
Hydrea Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 12/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf#page=15
Hydrea Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 12/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf#page=27
Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 PADDOCK LABS LLC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf
Hyrimoz Adalimumab-Adaz INJECTABLE;INJECTION 761071 SANDOZ INC 10/30/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf#page=36
Hysingla ER Hydrocodone Bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 PURDUE PHARMA LP 11/14/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s009MG.pdf
Hysingla ER Hydrocodone Bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 PURDUE PHARMA LP 11/14/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s010lbl.pdf#page=37
Ibsrela Tenapanor Hydrochloride TABLET;ORAL 211801 ARDELYX INC 09/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211801s000lbl.pdf#page=13
Iclusig Ponatinib Hydrochloride TABLET;ORAL 203469 ARIAD 07/10/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf#page=24
Iclusig Ponatinib Hydrochloride TABLET;ORAL 203469 ARIAD 07/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s032lbl.pdf#page=29
Iclusig Ponatinib Hydrochloride TABLET;ORAL 203469 ARIAD 07/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203469s033lbl.pdf#page=29
Idhifa Enasidenib Mesylate TABLET;ORAL 209606 CELGENE CORP 11/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf#page=17
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 09/18/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352352.pdf
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf#page=20
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s097lbl.pdf#page=21
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf#page=19
Ilumya Tildrakizumab-Asmn INJECTABLE;INJECTION 761067 SUN PHARMA GLOBAL 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf#page=10
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 11/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf#page=24
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 11/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s012lbl.pdf#page=30
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 11/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s018lbl.pdf#page=29
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 11/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s020lbl.pdf#page=30
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 11/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s023s024s025lbl.pdf#page=32
Imipramine Hydrochloride Imipramine Hydrochloride TABLET;ORAL 087846 SPECGX LLC 06/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf#page=3
Incivek Telaprevir TABLET;ORAL 201917 VERTEX PHARMS 03/25/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf
Indocin Indomethacin CAPSULE;ORAL 016059 EGALET 03/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016059s100lbl.pdf#page=23
Indocin Indomethacin SUPPOSITORY;RECTAL 017814 EGALET 03/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017814s043lbl.pdf#page=23
Indocin Indomethacin SUSPENSION;ORAL 018332 EGALET 03/26/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088612.pdf
Indocin Indomethacin SUSPENSION;ORAL 018332 EGALET 03/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018332s040lbl.pdf#page=23
Indocin SR Indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185 EGALET 03/26/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501640.pdf
Indocin SR Indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185 EGALET 03/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018185s057lbl.pdf#page=23
Inflectra Infliximab-Dyyb INJECTABLE;INJECTION 125544 CELLTRION INC 06/18/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM497384.pdf
Inflectra Infliximab-Dyyb INJECTABLE;INJECTION 125544 CELLTRION INC 06/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125544s009lbl.pdf#page=59
Inrebic Fedratinib Hydrochloride CAPSULE;ORAL 212327 IMPACT 08/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf#page=22
Intermezzo Zolpidem Tartrate TABLET;SUBLINGUAL 022328 PURDUE PHARMA 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf#page=20
Intron A Interferon Alfa-2b VIAL 103132 SCHERING 05/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf#page=40
Invirase Saquinavir Mesylate CAPSULE;ORAL 020628 HOFFMANN LA ROCHE 03/28/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf
Invirase Saquinavir Mesylate CAPSULE;ORAL 020628 HOFFMANN LA ROCHE 03/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf#page=25
Invirase Saquinavir Mesylate CAPSULE;ORAL 020628 HOFFMANN LA ROCHE 03/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf#page=24
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 09/18/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf#page=25
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf#page=24
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021785s024lbl.pdf#page=26
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021785s025lbl.pdf#page=25
Invokamet Canagliflozin; METformin Hydrochloride TABLET;ORAL 204353 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf#page=59
Invokamet Canagliflozin; METformin Hydrochloride TABLET;ORAL 204353 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf#page=58
Invokamet XR Canagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf#page=59
Invokamet XR Canagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf#page=58
Invokana Canagliflozin TABLET;ORAL 204042 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204042s032lbl.pdf#page=49
Invokana Canagliflozin TABLET;ORAL 204042 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s034lbl.pdf#page=48
Invokana Canagliflozin TABLET;ORAL 204042 JANSSEN PHARMS 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204042s036lbl.pdf#page=49
Ixifi Infliximab-Qbtx INJECTABLE;INJECTION 761072 PFIZER INC 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761072s006lbl.pdf#page=43
Jadenu Deferasirox TABLET;ORAL 206910 NOVARTIS PHARMS CORP 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s012lbl.pdf#page=29
Jadenu Deferasirox TABLET;ORAL 206910 NOVARTIS PHARMS CORP 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206910s015lbl.pdf#page=31
Jadenu Sprinkle Deferasirox GRANULE;ORAL 207968 NOVARTIS 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf#page=29
Jadenu Sprinkle Deferasirox GRANULE;ORAL 207968 NOVARTIS 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf#page=31
Janumet Metformin Hydrochloride; Sitagliptin Phosphate TABLET;ORAL 022044 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022044s043lbl.pdf#page=32
Janumet Metformin Hydrochloride; Sitagliptin Phosphate TABLET;ORAL 022044 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022044s046lbl.pdf#page=33
Janumet Metformin Hydrochloride; Sitagliptin Phosphate TABLET;ORAL 022044 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022044s047lbl.pdf#page=32
Janumet XR Metformin Hydrochloride; Sitagliptin Phosphate TABLET, EXTENDED RELEASE;ORAL 202270 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf#page=32
Januvia Sitagliptin Phosphate TABLET;ORAL 021995 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf#page=24
Januvia Sitagliptin Phosphate TABLET;ORAL 021995 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s045lbl.pdf#page=27
Januvia Sitagliptin Phosphate TABLET;ORAL 021995 MERCK SHARP DOHME 08/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf#page=24
Jardiance Empagliflozin TABLET;ORAL 204629 BOEHRINGER INGELHEIM 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf#page=32
Jardiance Empagliflozin TABLET;ORAL 204629 BOEHRINGER INGELHEIM 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf#page=34
Jardiance Empagliflozin TABLET;ORAL 204629 BOEHRINGER INGELHEIM 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf#page=33
Jentadueto Linagliptin; METformin Hydrochloride TABLET;ORAL 201281 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s025lbl.pdf#page=20
Jentadueto Linagliptin; METformin Hydrochloride TABLET;ORAL 201281 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201281s024lbl.pdf#page=22
Jentadueto XR Linagliptin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208026s013lbl.pdf#page=20
Jentadueto XR Linagliptin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 BOEHRINGER INGELHEIM 03/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208026s012lbl.pdf#page=22
Jeuveau Prabotulinumtoxina-Xvfs INJECTABLE;INJECTION 761085 EVOLUS INC 07/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761085s000lbl.pdf#page=9
Jornay PM Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311 IRONSHORE PHARMS 05/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf#page=19
Jornay PM Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311 IRONSHORE PHARMS 05/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209311s003lbl.pdf#page=19
Juvisync Simvastatin; Sitagliptin Phosphate TABLET;ORAL 202343 MERCK SHARP DOHME 02/24/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf
Juxtapid Lomitapide Mesylate CAPSULE;ORAL 203858 AMRYT 12/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf#page=32
Jynarque Tolvaptan TABLET;ORAL 204441 OTSUKA PHARM CO LTD 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 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020616s063lbl.pdf#page=34
Kalbitor Ecallantide INJECTABLE; INJECTION 125277 DYAX CORP. 09/08/2014 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277MedGuide.pdf
Kaletra Lopinavir; Ritonavir CAPSULE;ORAL 021226 ABBVIE 10/21/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s048lbl.pdf#page=52
Kaletra Lopinavir; Ritonavir CAPSULE;ORAL 021226 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf#page=50
Kaletra Lopinavir; Ritonavir CAPSULE;ORAL 021226 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021226s047lbl.pdf#page=53
Kaletra Lopinavir; Ritonavir CAPSULE;ORAL 021226 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf#page=53
Kaletra Lopinavir; Ritonavir SOLUTION;ORAL 021251 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51
Kaletra Lopinavir; Ritonavir SOLUTION;ORAL 021251 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf#page=52
Kaletra Lopinavir; Ritonavir SOLUTION;ORAL 021251 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53
Kaletra Lopinavir; Ritonavir TABLET;ORAL 021906 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51
Kaletra Lopinavir; Ritonavir TABLET;ORAL 021906 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021251s058,021906s053lbl.pdf#page=52
Kaletra Lopinavir; Ritonavir TABLET;ORAL 021906 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53
Kazano Alogliptin Benzoate; METformin Hydrochloride TABLET;ORAL 203414 TAKEDA PHARMS USA 07/01/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337729.pdf
Kazano Alogliptin Benzoate; METformin Hydrochloride TABLET;ORAL 203414 TAKEDA PHARMS USA 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf#page=32
Keppra Levetiracetam TABLET;ORAL 021035 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf#page=32
Keppra Levetiracetam TABLET;ORAL 021035 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf#page=31
Keppra Levetiracetam SOLUTION;ORAL 021505 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102,021505s042lbl.pdf#page=32
Keppra Levetiracetam SOLUTION;ORAL 021505 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf#page=31
Keppra XR Levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022285s029lbl.pdf#page=26
Kesimpta Ofatumumab SOLUTION;SUBCUTANEOUS 125326 NOVARTIS 08/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf#page=13
Ketek Telithromycin TABLET;ORAL 021144 SANOFI AVENTIS US 11/04/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088615.pdf
Ketek Telithromycin TABLET;ORAL 021144 SANOFI AVENTIS US 11/04/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf#page=29
Kevzara Sarilumab INJECTABLE;INJECTION 761037 SANOFI SYNTHELABO 04/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf#page=27
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s088lbl.pdf#page=98
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s048lbl.pdf#page=94
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s067lbl.pdf#page=86
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s068lbl.pdf#page=87
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s071s090lbl.pdf#page=87
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s084lbl.pdf#page=89
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s085lbl.pdf#page=93
Khedezla Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204683 OSMOTICA PHARM CORP 01/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf#page=24
Khedezla Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204683 OSMOTICA PHARM CORP 01/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204683s006lbl.pdf#page=24
Klonopin Clonazepam TABLET;ORAL 017533 ROCHE 10/25/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf#page=19
Klonopin Rapidly Disintegrating Clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813 ROCHE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf#page=20
Kombiglyze XR Metformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 ASTRAZENECA AB 07/01/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280360.pdf
Kombiglyze XR Metformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 ASTRAZENECA AB 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf#page=47
Kombiglyze XR Metformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 ASTRAZENECA AB 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf#page=47
Korlym Mifepristone TABLET;ORAL 202107 CORCEPT THERAP 11/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf#page=19
Korlym Mifepristone TABLET;ORAL 202107 CORCEPT THERAP 11/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202107s008lbl.pdf#page=20
Krystexxa Pegloticase INJECTABLE; INJECTION 125293 HORIZON PHARMA 07/13/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227568.pdf
Krystexxa Pegloticase INJECTABLE; INJECTION 125293 HORIZON PHARMA 07/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf#page=14
Kynamro Mipomersen Sodium SOLUTION;SUBCUTANEOUS 203568 KASTLE THERAPS LLC 03/18/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf
Lacosamide Lacosamide SOLUTION;ORAL 204839 AMNEAL PHARMS 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LacosamideTabletsCVMedGuide.pdf
Lacosamide Lacosamide TABLET;ORAL 204855 ACTAVIS LABS FL INC 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE TABLETSMedGuide.pdf
Lacosamide Lacosamide TABLET;ORAL 204857 AMNEAL PHARMS NY 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE ORAL SOLUTIONMed Guide.pdf
Lamictal Lamotrigine TABLET;ORAL 020241 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s060,020764s053,022251s024lbl.pdf#page=64
Lamictal Lamotrigine TABLET;ORAL 020241 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241Orig1s061ltr,020764Orig1s054,022251Orig1s025lbl.pdf#page=65
Lamictal Lamotrigine TABLET;ORAL 020241 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s058,020764s051,022251s022lbl.pdf#page=65
Lamictal Lamotrigine TABLET;ORAL 020241 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s062,020764s055,022251s026,022115s027lbl.pdf#page=65
Lamictal CD Lamotrigine TABLET, CHEWABLE;ORAL 020764 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s060,020764s053,022251s024lbl.pdf#page=64
Lamictal CD Lamotrigine TABLET, CHEWABLE;ORAL 020764 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241Orig1s061ltr,020764Orig1s054,022251Orig1s025lbl.pdf#page=65
Lamictal CD Lamotrigine TABLET, CHEWABLE;ORAL 020764 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s058,020764s051,022251s022lbl.pdf#page=65
Lamictal ODT Lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64
Lamictal ODT Lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020241s060,020764s053,022251s024lbl.pdf#page=64
Lamictal ODT Lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241Orig1s061ltr,020764Orig1s054,022251Orig1s025lbl.pdf#page=65
Lamictal ODT Lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020241s058,020764s051,022251s022lbl.pdf#page=65
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022115s026lbl.pdf#page=50
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115 GLAXOSMITHKLINE LLC 10/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022115s024lbl.pdf#page=51
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE; ORAL 022509 SMITHKLINE BEECHAM 01/29/2010 https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.pdf#page=39
Lamisil Terbinafine Hydrochloride TABLET;ORAL 020539 NOVARTIS 03/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf#page=11
Lamisil Terbinafine Hydrochloride GRANULE;ORAL 022071 NOVARTIS 03/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf#page=10
Lamivudine, Nevirapine and Zidovudine Lamivudine; Nevirapine; Zidovudine TABLET;ORAL 205626 MICRO LABS 08/13/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205626s000lbl.pdf#page=50
Lariam Mefloquine Hydrochloride TABLET;ORAL 019591 ROCHE 04/29/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088616.pdf
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 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf#page=35
Lazanda Fentanyl Citrate SPRAY, METERED;NASAL 022569 BTCP PHARMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022569s027lbl.pdf#page=33
Lemtrada Alemtuzumab INJECTABLE;INJECTION 103948 GENZYME 10/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103948s5177s5179lbl.pdf#page=30
Letairis Ambrisentan TABLET;ORAL 022081 GILEAD 08/23/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf
Letairis Ambrisentan TABLET;ORAL 022081 GILEAD 08/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf#page=26
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 06/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf#page=51
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 06/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s070lbl.pdf#page=52
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 06/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s071lbl.pdf#page=53
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 06/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020634s073lbl.pdf#page=54
Levaquin Levofloxacin INJECTABLE;INJECTION 020635 JANSSEN PHARMS 02/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
Levaquin Levofloxacin SOLUTION;ORAL 021721 JANSSEN PHARMS 02/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
Levaquin in Dextrose 5% in Plastic Container Levofloxacin INJECTABLE;INJECTION 020635 JANSSEN PHARMS 02/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
Lexapro Escitalopram Oxalate TABLET;ORAL 021323 ALLERGAN 08/28/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24
Lexapro Escitalopram Oxalate SOLUTION;ORAL 021365 ALLERGAN 08/28/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24
Librax Chlordiazepoxide Hydrochloride; Clidinium Bromide CAPSULE;ORAL 012750 BAUSCH 01/13/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012750s065lbl.pdf#page=8
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 11/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s003lbl.pdf#page=19
Libtayo Cemiplimab-Rwlc INJECTABLE;INTRAVENOUS 761097 REGENERON PHARMACEUTICALS 11/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s005lbl.pdf#page=15
Licart Diclofenac Epolamine SYSTEM;TOPICAL 206976 IBSA INST BIO 05/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206976s000lbl.pdf#page=22
Licart Diclofenac Epolamine SYSTEM;TOPICAL 206976 IBSA INST BIO 05/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206976s002lbl.pdf#page=20
Limbitrol Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 016949 HERITAGE PHARMS INC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf#page=12
Limbitrol DS Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 016949 HERITAGE PHARMS INC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf#page=12
Lindane Lindane SHAMPOO;TOPICAL 087266 OLTA PHARMS 04/05/2004 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneLotionMedGuide.pdf
Lindane Lindane LOTION;TOPICAL 087313 OLTA PHARMS 09/04/2001 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneShampooMedGuide.pdf
Linzess Linaclotide CAPSULE;ORAL 202811 ALLERGAN 09/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf#page=20
Linzess Linaclotide CAPSULE;ORAL 202811 ALLERGAN 09/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf#page=21
Lithium Carbonate Lithium Carbonate CAPSULE;ORAL 017812 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19
Lithium Carbonate Lithium Carbonate CAPSULE;ORAL 017812 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf#page=19
Lithium Carbonate Lithium Carbonate CAPSULE;ORAL 017812 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20
Lithium Carbonate Lithium Carbonate TABLET;ORAL 018558 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19
Lithium Carbonate Lithium Carbonate TABLET;ORAL 018558 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf#page=19
Lithium Carbonate Lithium Carbonate TABLET;ORAL 018558 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20
Lithium Citrate Lithium Citrate SYRUP;ORAL 018421 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19
Lithium Citrate Lithium Citrate SYRUP;ORAL 018421 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s033,018421s032,018558s027lbl.pdf#page=19
Lithium Citrate Lithium Citrate SYRUP;ORAL 018421 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20
Lotronex Alosetron Hydrochloride TABLET;ORAL 021107 SEBELA IRELAND LTD 04/03/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf
Lumoxiti Moxetumomab Pasudotox-Tdfk INJECTABLE;INJECTION 761104 INNATE PHARMA 08/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf#page=18
Lumoxiti Moxetumomab Pasudotox-Tdfk INJECTABLE;INJECTION 761104 INNATE PHARMA 08/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s001lbl.pdf#page=18
Lumoxiti Moxetumomab Pasudotox-Tdfk INJECTABLE;INJECTION 761104 INNATE PHARMA 08/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf#page=18
Lunesta Eszopiclone TABLET;ORAL 021476 SUNOVION PHARMS INC 08/18/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134691.pdf
Lunesta Eszopiclone TABLET;ORAL 021476 SUNOVION PHARMS INC 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf#page=26
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 04/07/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf#page=20
Lupron Depot-Ped Kit Leuprolide Acetate POWDER;INTRAMUSCULAR 020263 ABBVIE ENDOCRINE INC 04/07/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020263s046lbl.pdf#page=21
Luvox Fluvoxamine Maleate TABLET;ORAL 021519 ANI PHARMS 12/16/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf#page=30
Luvox Fluvoxamine Maleate TABLET;ORAL 021519 ANI PHARMS 12/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021519s012lbl.pdf#page=32
Luvox Fluvoxamine Maleate TABLET; ORAL 022235 JAZZ 04/14/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249169.pdf
Luvox CR Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE;ORAL 022033 JAZZ PHARMS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf#page=26
Lynparza Olaparib CAPSULE;ORAL 206162 ASTRAZENECA PHARMS 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf#page=16
Lynparza Olaparib CAPSULE;ORAL 206162 ASTRAZENECA PHARMS 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558s010lbl.pdf#page=37
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf#page=23
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s005lbl.pdf#page=27
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558s009lbl.pdf#page=32
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s013lbl.pdf#page=41
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf#page=50
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 11/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s018lbl.pdf#page=50
Lyrica Pregabalin CAPSULE;ORAL 021446 PFIZER 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf#page=50
Lyrica Pregabalin CAPSULE;ORAL 021446 PFIZER 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54
Lyrica Pregabalin CAPSULE;ORAL 021446 PFIZER 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56
Lyrica Pregabalin SOLUTION;ORAL 022488 PFIZER 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54
Lyrica Pregabalin SOLUTION;ORAL 022488 PFIZER 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56
Lyrica CR Pregabalin TABLET, EXTENDED RELEASE;ORAL 209501 PFIZER 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29
Magnevist Gadopentetate Dimeglumine INJECTABLE;INJECTION 019596 BAYER HLTHCARE 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12
Magnevist Gadopentetate Dimeglumine INJECTABLE;INJECTION 021037 BAYER HLTHCARE 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13
Marplan Isocarboxazid TABLET;ORAL 011961 VALIDUS PHARMS INC 11/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf#page=16
Mavenclad Cladribine TABLET;ORAL 022561 EMD SERONO INC 03/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf#page=29
Mayzent Siponimod Fumaric Acid TABLET;ORAL 209884 NOVARTIS 07/31/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209884s002lbl.pdf#page=22
Mayzent Siponimod Fumaric Acid TABLET;ORAL 209884 NOVARTIS 07/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209884s000lbl.pdf#page=22
Meridia Sibutramine Hydrochloride CAPSULE;ORAL 020632 ABBOTT 08/04/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf
Metadate CD Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259 LANNETT CO INC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf#page=20
Methylin Methylphenidate Hydrochloride SOLUTION;ORAL 021419 SPECGX LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf#page=12
Methylin Methylphenidate Hydrochloride TABLET, CHEWABLE;ORAL 021475 SPECGX LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf#page=13
Metoclopramide Hydrochloride Metoclopramide Hydrochloride SOLUTION;ORAL 074703 WOCKHARDT BIO AG 04/08/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM244086.pdf
Metozolv ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246 SALIX PHARMS 02/28/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187064.pdf
Metozolv ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246 SALIX PHARMS 02/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf#page=18
Mifeprex Mifepristone TABLET;ORAL 020687 DANCO LABS LLC 04/11/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf
Mifeprex Mifepristone TABLET;ORAL 020687 DANCO LABS LLC 04/11/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020687s022lbl.pdf#page=16
Mircera Methoxy Polyethylene Glycol-Epoetin Beta SOLUTION; INJECTION 125164 HOFFMAN-LA ROCHE 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf#page=23
Mitigare Colchicine CAPSULE;ORAL 204820 HIKMA INTL PHARMS 09/26/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf
Mobic Meloxicam TABLET;ORAL 020938 BOEHRINGER INGELHEIM 06/30/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf
Mobic Meloxicam SUSPENSION;ORAL 021530 AVONDALE PHARMS 09/01/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf
Morphabond ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 206544 DAIICHI SANKYO INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf#page=38
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 022195 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022195s018lbl.pdf#page=28
Morphine Sulfate Morphine Sulfate TABLET;ORAL 022207 HIKMA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022207s009lbl.pdf#page=26
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 201517 LANNETT CO INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf#page=28
Motrin Ibuprofen TABLET;ORAL 017463 MCNEIL CONSUMER 09/10/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088647.pdf
Movantik Naloxegol Oxalate TABLET;ORAL 204760 REDHILL 04/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf#page=16
Movantik Naloxegol Oxalate TABLET;ORAL 204760 REDHILL 04/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf#page=16
Movantik Naloxegol Oxalate TABLET;ORAL 204760 REDHILL 04/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf#page=16
Moviprep Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 021881 SALIX PHARMS 11/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021881s017lbl.pdf#page=13
Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 205572 FRESENIUS KABI USA 03/27/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088619.pdf
Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 205572 FRESENIUS KABI USA 03/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205572s006lbl.pdf#page=49
Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 205572 FRESENIUS KABI USA 03/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205572s007lbl.pdf#page=49
MS Contin Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 019516 PURDUE PHARMA LP 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf#page=27
Multaq Dronedarone Hydrochloride TABLET;ORAL 022425 SANOFI AVENTIS US 11/16/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM171764.pdf
Multaq Dronedarone Hydrochloride TABLET;ORAL 022425 SANOFI AVENTIS US 11/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf#page=22
Multihance Gadobenate Dimeglumine INJECTABLE;INTRAVENOUS 021357 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34
Multihance Multipack Gadobenate Dimeglumine INJECTABLE;INTRAVENOUS 021358 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34
Myalept Metreleptin INJECTABLE;INJECTION 125390 AEGERION 07/13/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf#page=14
Mydayis Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 TAKEDA PHARMS USA 09/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf#page=22
Myfortic Mycophenolic Acid TABLET, DELAYED RELEASE;ORAL 050791 NOVARTIS 04/28/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172735.pdf
Myfortic Mycophenolic Acid TABLET, DELAYED RELEASE;ORAL 050791 NOVARTIS 04/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf#page=25
Myfortic Mycophenolic Acid TABLET, DELAYED RELEASE;ORAL 050791 NOVARTIS 04/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050791s030lbl.pdf#page=24
Myobloc Botulinum Toxin Type B VIAL 103846 ELAN PHARM 08/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103846s5190lbl.pdf#page=18
Mysoline Primidone TABLET;ORAL 009170 VALEANT 06/10/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035MedGuide.pdf
Mysoline Primidone TABLET;ORAL 009170 VALEANT 06/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf#page=7
Nalfon Fenoprofen Calcium CAPSULE;ORAL 017604 XSPIRE PHARMA 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf
Naprelan Naproxen Sodium TABLET, EXTENDED RELEASE;ORAL 020353 ALVOGEN 07/22/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280324.pdf
Naprelan Naproxen Sodium TABLET, EXTENDED RELEASE;ORAL 020353 ALVOGEN 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf#page=21
Naprosyn Naproxen TABLET;ORAL 017581 ATNAHS PHARMA US 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf#page=22
Naprosyn Naproxen SUSPENSION;ORAL 018965 ATNAHS PHARMA US 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018965s025lbl.pdf#page=21
Nardil Phenelzine Sulfate TABLET;ORAL 011909 PARKE DAVIS 08/02/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088660.pdf
Natpara Parathyroid Hormone INJECTABLE;INJECTION 125511 NPS PHARMS INC 07/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf#page=18
Natpara Parathyroid Hormone INJECTABLE;INJECTION 125511 NPS PHARMS INC 07/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s016lbl.pdf#page=18
Natpara Parathyroid Hormone INJECTABLE;INJECTION 125511 NPS PHARMS INC 07/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/natparaMedGuide.pdf
Nayzilam Midazolam SPRAY;NASAL 211321 UCB INC 05/17/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211321s000lbl.pdf#page=24
Nerlynx Neratinib Maleate TABLET;ORAL 208051 PUMA BIOTECH 07/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf#page=19
Nesina Alogliptin Benzoate TABLET;ORAL 022271 TAKEDA PHARMS USA 07/01/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337732.pdf
Nesina Alogliptin Benzoate TABLET;ORAL 022271 TAKEDA PHARMS USA 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf#page=29
Neurontin Gabapentin CAPSULE;ORAL 020235 UPJOHN 04/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32
Neurontin Gabapentin TABLET;ORAL 020882 UPJOHN 04/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32
Neurontin Gabapentin SOLUTION;ORAL 021129 UPJOHN 04/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32
Nexium Esomeprazole Magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153 ASTRAZENECA PHARMS 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf#page=33
Nexium Esomeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957 ASTRAZENECA PHARMS 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf#page=33
Nexium Esomeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101 ASTRAZENECA PHARMS 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021153s057,021957s024,022101s021lbl.pdf#page=33
Nizoral Ketoconazole TABLET;ORAL 018533 JANSSEN PHARMS 02/25/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf
Nocdurna Desmopressin Acetate TABLET;SUBLINGUAL 022517 FERRING PHARMS INC 06/21/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf#page=14
Noctiva Desmopressin Acetate SPRAY, METERED;NASAL 201656 ALYVANT 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 10/07/2019 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 US PHARM HOLDINGS 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 11/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125268s164lbl.pdf#page=16
Nucynta Tapentadol Hydrochloride TABLET;ORAL 022304 COLLEGIUM PHARM INC 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf#page=32
Nucynta Tapentadol Hydrochloride TABLET;ORAL 022304 COLLEGIUM PHARM INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf#page=32
Nucynta Tapentadol Hydrochloride TABLET;ORAL 022304 COLLEGIUM PHARM INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022304s022lbl.pdf#page=33
Nucynta Tapentadol Hydrochloride SOLUTION;ORAL 203794 COLLEGIUM PHARM INC 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000mg.pdf
Nucynta Tapentadol Hydrochloride SOLUTION;ORAL 203794 COLLEGIUM PHARM INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203794s008lbl.pdf#page=35
Nucynta ER Tapentadol Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 COLLEGIUM PHARM INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200533s020lbl.pdf#page=34
Nulojix Belatacept INJECTABLE; INJECTION 125288 BRISTOL MYERS SQUIBB 04/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49
Nulytely Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION;ORAL 019797 BRAINTREE 09/23/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf
Nulytely-Flavored Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION;ORAL 019797 BRAINTREE 09/23/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf
Nuvigil Armodafinil TABLET;ORAL 021875 CEPHALON 02/07/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231717.pdf
Obredon Guaifenesin; Hydrocodone Bitartrate SOLUTION;ORAL 205474 SOVEREIGN PHARMS 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205474s005lbl.pdf#page=23
Ocaliva Obeticholic Acid TABLET;ORAL 207999 INTERCEPT PHARMS INC 02/01/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf#page=23
Ocrevus Ocrelizumab INJECTABLE;INJECTION 761053 GENENTECH INC 11/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf#page=17
Ocrevus Ocrelizumab INJECTABLE;INJECTION 761053 GENENTECH INC 11/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf#page=17
Ocrevus Ocrelizumab INJECTABLE;INJECTION 761053 GENENTECH INC 11/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s023lbl.pdf#page=19
Ocrevus Ocrelizumab INJECTABLE;INJECTION 761053 GENENTECH INC 11/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf#page=18
Odomzo Sonidegib Phosphate CAPSULE;ORAL 205266 SUN PHARMA GLOBAL 05/13/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf#page=12
Odomzo Sonidegib Phosphate CAPSULE;ORAL 205266 SUN PHARMA GLOBAL 05/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266Orig1s000lbl.pdf#page=12
Odomzo Sonidegib Phosphate CAPSULE;ORAL 205266 SUN PHARMA GLOBAL 05/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205266s006lbl.pdf#page=13
Oleptro Trazodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411 ANGELINI PHARMA 07/17/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf
Olumiant Baricitinib TABLET;ORAL 207924 ELI LILLY AND CO 07/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207924s001lbl.pdf#page=18
Olumiant Baricitinib TABLET;ORAL 207924 ELI LILLY AND CO 07/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207924s002lbl.pdf#page=18
Omniscan Gadodiamide INJECTABLE;INJECTION 020123 GE HEALTHCARE 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1
Omniscan Gadodiamide INJECTABLE;INJECTION 022066 GE HEALTHCARE 10/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1
Omontys Peginesatide Acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799 TAKEDA PHARMS USA 12/04/2012 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf
Omontys Preservative Free Peginesatide Acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799 TAKEDA PHARMS USA 12/04/2012 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf
Onfi Clobazam TABLET;ORAL 202067 LUNDBECK PHARMS LLC 06/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29
Onfi Clobazam SUSPENSION;ORAL 203993 LUNDBECK PHARMS LLC 06/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29
Onglyza Saxagliptin Hydrochloride TABLET;ORAL 022350 ASTRAZENECA AB 07/01/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf#page=31
Onglyza Saxagliptin Hydrochloride TABLET;ORAL 022350 ASTRAZENECA AB 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf#page=31
Onsolis Fentanyl Citrate FILM;BUCCAL 022266 BDSI 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.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 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021610s027lbl.pdf#page=26
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 11/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s071lbl.pdf#page=100
Opsumit Macitentan TABLET;ORAL 204410 ACTELION PHARMS LTD 04/08/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204410s010lbl.pdf#page=20
Optimark Gadoversetamide INJECTABLE;INJECTION 020937 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf#page=13
Optimark Gadoversetamide INJECTABLE;INJECTION 020937 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=14
Optimark Gadoversetamide INJECTABLE;INJECTION 020975 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=29
Optimark Gadoversetamide INJECTABLE;INJECTION 020975 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf#page=13
Optimark in Plastic Container Gadoversetamide INJECTABLE;INJECTION 020976 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=43
Optimark in Plastic Container Gadoversetamide INJECTABLE;INJECTION 020976 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf#page=13
Oriahnn (Copackaged) Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium CAPSULE;ORAL 213388 ABBVIE INC 05/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213388s000lbl.pdf#page=29
Orilissa Elagolix Sodium TABLET;ORAL 210450 ABBVIE INC 08/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210450s002lbl.pdf#page=27
Oseni Alogliptin Benzoate; Pioglitazone Hydrochloride TABLET;ORAL 022426 TAKEDA PHARMS USA 07/01/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf#page=42
Oseni Alogliptin Benzoate; Pioglitazone Hydrochloride TABLET;ORAL 022426 TAKEDA PHARMS USA 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf#page=43
Osmoprep Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate TABLET;ORAL 021892 SALIX PHARMS 11/29/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006mg.pdf
Osmoprep Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate TABLET;ORAL 021892 SALIX PHARMS 11/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf#page=13
Oxaydo Oxycodone Hydrochloride TABLET;ORAL 202080 ZYLA 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf#page=26
Oxaydo Oxycodone Hydrochloride TABLET;ORAL 202080 ZYLA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf#page=27
Oxaydo Oxycodone Hydrochloride TABLET;ORAL 202080 ZYLA 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf#page=29
Oxtellar XR Oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810 SUPERNUS PHARMS 12/13/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf
Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE;ORAL 200534 GENUS LIFESCIENCES 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf#page=29
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 200535 GENUS LIFESCIENCES 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000MedGuide.pdf
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 200535 GENUS LIFESCIENCES 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf#page=32
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 201194 VISTAPHARM 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf#page=30
Oxycontin Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272 PURDUE PHARMA LP 11/14/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022272s042MG.pdf
Oxycontin Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272 PURDUE PHARMA LP 11/14/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022272s043lbl.pdf#page=47
Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046 ACTAVIS ELIZABETH 10/10/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf
Ozempic Semaglutide SOLUTION;SUBCUTANEOUS 209637 NOVO 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf#page=24
Ozempic Semaglutide SOLUTION;SUBCUTANEOUS 209637 NOVO 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf#page=24
Pacerone Amiodarone Hydrochloride TABLET;ORAL 075135 UPSHER SMITH LABS 11/01/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf
Palladone Hydromorphone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044 PURDUE PHARMA LP 04/16/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf
Palynziq Pegvaliase-Pqpz INJECTABLE;INJECTION 761079 BIOMARIN PHARM 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf#page=23
Pamelor Nortriptyline Hydrochloride SOLUTION;ORAL 018012 SPECGX LLC 07/28/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf
Pamelor Nortriptyline Hydrochloride CAPSULE;ORAL 018013 SPECGX LLC 04/09/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf
Pamelor Nortriptyline Hydrochloride CAPSULE;ORAL 018013 SPECGX LLC 04/09/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf#page=15
Pancreaze Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022523 VIVUS INC 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf#page=16
Parnate Tranylcypromine Sulfate TABLET;ORAL 012342 CONCORDIA 01/04/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088674.pdf
Paxil Paroxetine Hydrochloride TABLET;ORAL 020031 APOTEX TECHNOLOGIES 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43
Paxil Paroxetine Hydrochloride SUSPENSION;ORAL 020710 APOTEX TECHNOLOGIES 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43
Paxil CR Paroxetine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936 APOTEX TECHNOLOGIES 09/11/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020936s047lbl.pdf#page=29
Peganone Ethotoin TABLET;ORAL 010841 RECORDATI RARE 02/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf
Pegasys Peginterferon Alfa-2a SYRINGE 103964 HOFFMAN-LA ROCHE 10/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39
Pegasys Peginterferon Alfa-2a VIAL; SUBCUTANEOUS 103964 HOFFMAN-LA ROCHE 10/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39
Pegintron Peginterferon Alfa-2b SYRINGE 103949 SCHERING 01/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27
Pegintron Peginterferon Alfa-2b VIAL 103949 SCHERING 01/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27
Pegintron Peginterferon Alfa-2b SYRINGE 103949 SCHERING 01/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13
Pegintron Peginterferon Alfa-2b VIAL 103949 SCHERING 01/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13
Pegintron Peginterferon Alfa-2b SYRINGE 103949 SCHERING 01/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29
Pegintron Peginterferon Alfa-2b VIAL 103949 SCHERING 01/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29
Pennsaid Diclofenac Sodium SOLUTION;TOPICAL 020947 NUVO PHARMS INC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf
Percocet Acetaminophen; Oxycodone Hydrochloride TABLET;ORAL 040330 VINTAGE PHARMS LLC 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/040330s052lbl.pdf
Percodan Aspirin; Oxycodone Hydrochloride TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24
Percodan Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24
Percodan Aspirin; Oxycodone Hydrochloride TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25
Percodan Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25
Percodan Aspirin; Oxycodone Hydrochloride TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf#page=26
Percodan Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf#page=26
Percodan-Demi Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24
Percodan-Demi Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25
Percodan-Demi Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/007337s052lbl.pdf#page=26
Perforomist Formoterol Fumarate SOLUTION;INHALATION 022007 MYLAN SPECLT 05/29/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214444.pdf
Perforomist Formoterol Fumarate SOLUTION;INHALATION 022007 MYLAN SPECLT 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf#page=19
Pexeva Paroxetine Mesylate TABLET;ORAL 021299 SEBELA IRELAND LTD 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf#page=38
Phenergan VC W/ Codeine Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride SYRUP;ORAL 008306 ANI PHARMS 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29
Phenergan W/ Codeine Codeine Phosphate; Promethazine Hydrochloride SYRUP;ORAL 008306 ANI PHARMS 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29
Plavix Clopidogrel Bisulfate TABLET;ORAL 020839 SANOFI AVENTIS US 05/17/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf#page=23
Plavix Clopidogrel Bisulfate TABLET;ORAL 020839 SANOFI AVENTIS US 05/17/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020839s072lbl.pdf#page=24
Plegridy Peginterferon Beta-1a INJECTABLE;INJECTION 125499 BIOGEN IDEC INC 03/27/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM475804.pdf
Plegridy Peginterferon Beta-1a INJECTABLE;INJECTION 125499 BIOGEN IDEC INC 03/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125499s018lbl.pdf#page=19
Plenvu Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 209381 SALIX 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf#page=17
Plenvu Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 209381 SALIX 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s001lbl.pdf#page=17
Plenvu Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 209381 SALIX 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s002lbl.pdf#page=17
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf#page=31
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf#page=31
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s023lbl.pdf#page=33
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s024lbl.pdf#page=33
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf#page=33
Ponstel Mefenamic Acid CAPSULE;ORAL 015034 AVION PHARMS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088692.pdf
Potiga Ezogabine TABLET;ORAL 022345 GLAXOSMITHKLINE 05/20/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf
Pradaxa Dabigatran Etexilate Mesylate CAPSULE;ORAL 022512 BOEHRINGER INGELHEIM 07/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022512s039lbl.pdf#page=24
Prepopik Citric Acid; Magnesium Oxide; Sodium Picosulfate FOR SOLUTION;ORAL 202535 FERRING PHARMS INC 08/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf#page=15
Pretomanid Pretomanid TABLET;ORAL 212862 MYLAN IRELAND LTD 08/14/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212862s000lbl.pdf#page=19
Prevacid Lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406 TAKEDA PHARMS USA 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf#page=44
Prevacid Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 TAKEDA PHARMS USA 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38
Prevacid Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 TAKEDA PHARMS USA 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s092,021428s039lbl.pdf#page=44
Prevacid Naprapac 250 (Copackaged) Lansoprazole; Naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507 TAKEDA PHARMS NA 07/31/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
Prevacid Naprapac 375 (Copackaged) Lansoprazole; Naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507 TAKEDA PHARMS NA 07/31/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
Prevacid Naprapac 500 (Copackaged) Lansoprazole; Naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507 TAKEDA PHARMS NA 07/31/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
Priftin Rifapentine TABLET;ORAL 021024 SANOFI AVENTIS US 06/09/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426514.pdf
Priftin Rifapentine TABLET;ORAL 021024 SANOFI AVENTIS US 06/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf#page=28
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA PHARMS 12/19/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322359.pdf
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA PHARMS 12/19/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA PHARMS 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 PHARMA BV 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf#page=34
Prilosec Omeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 COVIS PHARMA BV 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022056s023lbl.pdf#page=35
Pristiq Desvenlafaxine Succinate TABLET, EXTENDED RELEASE;ORAL 021992 PF PRISM CV 02/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf#page=35
Probuphine Buprenorphine Hydrochloride IMPLANT;IMPLANTATION 204442 TITAN PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204442s009lbl.pdf#page=49
Prohance Gadoteridol INJECTABLE;INJECTION 020131 BRACCO 04/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf#page=1
Prohance Multipack Gadoteridol INJECTABLE;INJECTION 021489 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf#page=1
Prolia Denosumab INJECTABLE; SUBCUTANEOUS 125320 AMGEN 06/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdf#page=30
Prolia Denosumab INJECTABLE; SUBCUTANEOUS 125320 AMGEN 06/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s205lbl.pdf#page=30
Promacta Eltrombopag Olamine TABLET;ORAL 022291 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s021lbl.pdf#page=35
Promacta Eltrombopag Olamine TABLET;ORAL 022291 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf#page=35
Promacta Kit Eltrombopag Olamine FOR SUSPENSION;ORAL 207027 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207027s008lbl.pdf#page=35
Promacta Kit Eltrombopag Olamine FOR SUSPENSION;ORAL 207027 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.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 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020MedGuide.pdf
Propylthiouracil Propylthiouracil TABLET;ORAL 006188 DAVA PHARMS INC 09/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf#page=7
Proquin XR Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744 DEPOMED INC 08/15/2011 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Proquin XR.pdf
Protonix Pantoprazole Sodium TABLET, DELAYED RELEASE;ORAL 020987 WYETH PHARMS 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf#page=33
Protonix Pantoprazole Sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020 WYETH PHARMS 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020987s056,022020s018lbl.pdf#page=33
Protopic Tacrolimus OINTMENT;TOPICAL 050777 LEO PHARMA AS 02/25/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088996.pdf
Provigil Modafinil TABLET;ORAL 020717 CEPHALON 01/15/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf
Prozac Fluoxetine Hydrochloride CAPSULE;ORAL 018936 ELI LILLY AND CO 04/28/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28
Prozac Fluoxetine Hydrochloride CAPSULE;ORAL 018936 ELI LILLY AND CO 04/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf#page=26
Prozac Weekly Fluoxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235 LILLY 03/24/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28
Qmiiz ODT Meloxicam TABLET, ORALLY DISINTEGRATING;ORAL 211210 TERSERA 08/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211210s000lbl.pdf#page=35
Qsymia Phentermine Hydrochloride; Topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580 VIVUS 10/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022580s017lbl.pdf#page=37
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 01/24/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s003lbl.pdf#page=37
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s000lbl.pdf
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s002lbl.pdf#page=40
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s004lbl.pdf#page=40
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209091s005lbl.pdf#page=37
Qternmet XR Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s000lbl.pdf#page=50
Qternmet XR Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210874s001lbl.pdf#page=50
Qternmet XR Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210874s003lbl.pdf#page=47
Qualaquin Quinine Sulfate CAPSULE;ORAL 021799 SUN PHARM INDUSTRIES 06/19/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM192698.pdf
Qualaquin Quinine Sulfate CAPSULE;ORAL 021799 SUN PHARM INDUSTRIES 06/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021799s029lbl.pdf#page=26
Qudexy XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 UPSHER SMITH LABS 02/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf#page=69
Qudexy XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 UPSHER SMITH LABS 02/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205122s008lbl.pdf#page=59
Qudexy XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 UPSHER SMITH LABS 02/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205122s010lbl.pdf#page=60
Quillichew ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NEXTWAVE PHARMS 02/28/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf#page=13
Quillivant XR Methylphenidate Hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100 NEXTWAVE 01/24/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf#page=14
Rapamune Sirolimus SOLUTION;ORAL 021083 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf#page=41
Rapamune Sirolimus SOLUTION;ORAL 021083 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s064,021110s083lbl.pdf#page=43
Rapamune Sirolimus SOLUTION;ORAL 021083 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s065,021110s084lbl.pdf#page=41
Rapamune Sirolimus SOLUTION;ORAL 021083 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf#page=43
Rapamune Sirolimus TABLET;ORAL 021110 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf#page=41
Rapamune Sirolimus TABLET;ORAL 021110 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s064,021110s083lbl.pdf#page=43
Rapamune Sirolimus TABLET;ORAL 021110 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s065,021110s084lbl.pdf#page=41
Rapamune Sirolimus TABLET;ORAL 021110 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf#page=43
Ravicti Glycerol Phenylbutyrate LIQUID;ORAL 203284 HORIZON THERAP 10/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf#page=1
Ravicti Glycerol Phenylbutyrate LIQUID;ORAL 203284 HORIZON THERAP 10/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203284s010lbl.pdf#page=27
Ravicti Glycerol Phenylbutyrate LIQUID;ORAL 203284 HORIZON THERAP 10/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203284s011lbl.pdf#page=27
Rebetol Ribavirin CAPSULE;ORAL 020903 MERCK SHARP DOHME 01/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf#page=26
Rebetol Ribavirin SOLUTION;ORAL 021546 SCHERING 01/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020903s056,021546s012lbl.pdf#page=26
Rebif Interferon Beta-1a SYRINGE 103780 SERONO INC 05/26/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089019.pdf
Rebif Interferon Beta-1a SYRINGE 103780 SERONO INC 05/26/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103780s5203s5207lbl.pdf#page=16
Reclast Zoledronic Acid INJECTABLE;INTRAVENOUS 021817 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf#page=25
Reclast Zoledronic Acid INJECTABLE;INTRAVENOUS 021817 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021817s028lbl.pdf#page=25
Reglan Metoclopramide Hydrochloride TABLET;ORAL 017854 ANI PHARMS 08/29/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf
Reglan Metoclopramide Hydrochloride INJECTABLE;INJECTION 017862 WEST-WARD PHARMS INT 11/18/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf
Reglan ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793 MEDA PHARMS 11/30/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf
Regranex Becaplermin GEL; TOPICAL 103691 SMITH AND NEPHEW 08/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103691s5134lbl.pdf#page=11
Regranex Becaplermin GEL; TOPICAL 103691 SMITH AND NEPHEW 08/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf#page=8
Relistor Methylnaltrexone Bromide SOLUTION;SUBCUTANEOUS 021964 SALIX PHARMS 03/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf#page=29
Relistor Methylnaltrexone Bromide TABLET;ORAL 208271 SALIX 03/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf#page=29
Remeron Mirtazapine TABLET;ORAL 020415 ORGANON USA INC 04/29/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026mg.pdf
Remeron Mirtazapine TABLET;ORAL 020415 ORGANON USA INC 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf#page=24
Remeron Mirtazapine TABLET;ORAL 020415 ORGANON USA INC 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf#page=23
Remeron Soltab Mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 ORGANON USA INC 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf#page=24
Remeron Soltab Mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 ORGANON USA INC 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021208s025lbl.pdf#page=24
Remeron Soltab Mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 ORGANON USA INC 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf#page=23
Remicade Infliximab VIAL 103772 CENTOCOR INC 05/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf#page=48
Remicade Infliximab VIAL 103772 CENTOCOR INC 05/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103772s5389s5391s5394lbl.pdf#page=50
Renflexis Infliximab-Abda INJECTABLE;INJECTION 761054 SAMSUNG BIOEPIS CO LTD 06/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054lbl.pdf#page=51
Renflexis Infliximab-Abda INJECTABLE;INJECTION 761054 SAMSUNG BIOEPIS CO LTD 06/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf#page=52
Renflexis Infliximab-Abda INJECTABLE;INJECTION 761054 SAMSUNG BIOEPIS CO LTD 06/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf#page=52
Restoril Temazepam CAPSULE;ORAL 018163 SPECGX LLC 02/06/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf#page=13
Restoril Temazepam CAPSULE;ORAL 018163 SPECGX LLC 02/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018163s065lbl.pdf#page=13
Retacrit Epoetin Alfa-Epbx INJECTABLE;INJECTION 125545 HOSPIRA INC 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf#page=28
Retacrit Epoetin Alfa-Epbx INJECTABLE;INJECTION 125545 HOSPIRA INC 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf#page=28
Retacrit Epoetin Alfa-Epbx INJECTABLE;INJECTION 125545 HOSPIRA INC 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf#page=31
Revlimid Lenalidomide CAPSULE;ORAL 021880 CELGENE 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf#page=42
Revlimid Lenalidomide CAPSULE;ORAL 021880 CELGENE 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s056lbl.pdf#page=42
Revlimid Lenalidomide CAPSULE;ORAL 021880 CELGENE 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s057lbl.pdf#page=49
Revlimid Lenalidomide CAPSULE;ORAL 021880 CELGENE 09/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021880s060lbl.pdf#page=49
Rexulti Brexpiprazole TABLET;ORAL 205422 OTSUKA PHARM CO LTD 06/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205422Orig1Orig2s000lbl.pdf#page=36
Rexulti Brexpiprazole TABLET;ORAL 205422 OTSUKA PHARM CO LTD 06/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf#page=27
Reyvow Lasmiditan Succinate TABLET;ORAL 211280 ELI LILLY AND CO 07/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211280s001lbl.pdf#page=14
Rezira Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride SOLUTION;ORAL 022442 PERSION 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf#page=26
Ribasphere Ribavirin CAPSULE;ORAL 076203 CHARTWELL RX 05/31/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111342.pdf
Rinvoq Upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675 ABBVIE INC 07/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211675s000lbl.pdf#page=28
Rinvoq Upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675 ABBVIE INC 07/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211675s001lbl.pdf#page=29
Ritalin Methylphenidate Hydrochloride TABLET;ORAL 010187 NOVARTIS 11/19/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf#page=11
Ritalin Methylphenidate Hydrochloride TABLET;ORAL 010187 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf#page=14
Ritalin Methylphenidate Hydrochloride TABLET;ORAL 010187 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf#page=13
Ritalin LA Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NOVARTIS 11/19/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021284s034lbl.pdf#page=18
Ritalin LA Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021284s016s029lbl.pdf#page=17
Ritalin LA Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021284s041lbl.pdf#page=16
Ritalin-SR Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 018029 NOVARTIS 11/19/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018029s055lbl.pdf#page=14
Ritalin-SR Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 018029 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s071s082,018029s041s051lbl.pdf#page=14
Ritalin-SR Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 018029 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf#page=13
Rituxan Rituximab SOLUTION;INTRAVENOUS 103705 GENENTECH 08/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf#page=46
Rituxan Hycela Rituximab; Hyaluronidase (Human Recombinant) SOLUTION;SUBCUTANEOUS 761064 GENENTECH INC 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf#page=29
Rituxan Hycela Rituximab; Hyaluronidase (Human Recombinant) SOLUTION;SUBCUTANEOUS 761064 GENENTECH INC 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761064s009lbl.pdf#page=26
Rituxan Hycela Rituximab; Hyaluronidase (Human Recombinant) SOLUTION;SUBCUTANEOUS 761064 GENENTECH INC 05/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf#page=28
Roxicodone Oxycodone Hydrochloride TABLET;ORAL 021011 SPECGX LLC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021011s010lbl.pdf#page=28
Roxybond Oxycodone Hydrochloride TABLET;ORAL 209777 OHEMO LIFE 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf#page=43
Roxybond Oxycodone Hydrochloride TABLET;ORAL 209777 OHEMO LIFE 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209777s006lbl.pdf#page=36
Rozerem Ramelteon TABLET;ORAL 021782 TAKEDA PHARMS USA 12/21/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011Medguide.pdf
Rozerem Ramelteon TABLET;ORAL 021782 TAKEDA PHARMS USA 12/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021782s021lbl.pdf#page=16
Ruxience Rituximab-Pvvr INJECTABLE;INJECTION 761103 PFIZER INC 05/26/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761103s000lbl.pdf#page=31
Ruxience Rituximab-Pvvr INJECTABLE;INJECTION 761103 PFIZER INC 05/26/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761103s003lbl.pdf#page=32
Ruzurgi Amifampridine TABLET;ORAL 209321 JACOBUS PHARM CO INC 08/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf#page=15
Rybelsus Semaglutide TABLET;ORAL 213051 NOVO 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf#page=24
Rybelsus Semaglutide TABLET;ORAL 213051 NOVO 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23
Rybelsus Semaglutide TABLET;ORAL 213182 NOVO NORDISK INC 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23
Sabril Vigabatrin TABLET;ORAL 020427 LUNDBECK PHARMS LLC 10/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26
Sabril Vigabatrin TABLET;ORAL 020427 LUNDBECK PHARMS LLC 10/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf#page=26
Sabril Vigabatrin FOR SOLUTION;ORAL 022006 LUNDBECK PHARMS LLC 10/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26
Sabril Vigabatrin FOR SOLUTION;ORAL 022006 LUNDBECK PHARMS LLC 10/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020427s020,022006s022lbl.pdf#page=26
Samsca Tolvaptan TABLET;ORAL 022275 OTSUKA AMERICA PHARM 04/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbl.pdf#page=24
Sarafem Fluoxetine Hydrochloride CAPSULE;ORAL 018936 ELI LILLY AND CO 04/28/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28
Sarafem Fluoxetine Hydrochloride CAPSULE;ORAL 018936 ELI LILLY AND CO 04/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf#page=26
Sarafem Fluoxetine Hydrochloride TABLET;ORAL 021860 APIL 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf#page=33
Sarafem Fluoxetine Hydrochloride TABLET;ORAL 021860 APIL 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089119.pdf
Savaysa Edoxaban Tosylate TABLET;ORAL 206316 DAIICHI SANKYO INC 04/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf#page=32
Savaysa Edoxaban Tosylate TABLET;ORAL 206316 DAIICHI SANKYO INC 04/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206316s015lbl.pdf#page=34
Savaysa Edoxaban Tosylate TABLET;ORAL 206316 DAIICHI SANKYO INC 04/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf#page=35
Savella Milnacipran Hydrochloride TABLET;ORAL 022256 ALLERGAN 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf#page=30
Saxenda Liraglutide Recombinant SOLUTION;SUBCUTANEOUS 206321 NOVO 03/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf#page=26
Saxenda Liraglutide Recombinant SOLUTION;SUBCUTANEOUS 206321 NOVO 03/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206321s011lbl.pdf#page=26
Segluromet Ertugliflozin; METformin Hydrochloride TABLET;ORAL 209806 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209806s001lbl.pdf#page=32
Segluromet Ertugliflozin; METformin Hydrochloride TABLET;ORAL 209806 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209806s002lbl.pdf#page=32
Selzentry Maraviroc TABLET;ORAL 022128 VIIV HLTHCARE 10/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43
Selzentry Maraviroc TABLET;ORAL 022128 VIIV HLTHCARE 10/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43
Selzentry Maraviroc SOLUTION;ORAL 208984 VIIV HLTHCARE 10/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43
Selzentry Maraviroc SOLUTION;ORAL 208984 VIIV HLTHCARE 10/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43
Serevent Salmeterol Xinafoate POWDER;INHALATION 020692 GLAXOSMITHKLINE 07/22/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf
Serevent Salmeterol Xinafoate POWDER;INHALATION 020692 GLAXOSMITHKLINE 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020692s046lbl.pdf#page=34
Serevent Salmeterol Xinafoate POWDER;INHALATION 020692 GLAXOSMITHKLINE 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf#page=35
Seroquel Quetiapine Fumarate TABLET;ORAL 020639 ASTRAZENECA PHARMS 09/18/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089126.pdf
Seroquel Quetiapine Fumarate TABLET;ORAL 020639 ASTRAZENECA PHARMS 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020639s070lbl.pdf#page=106
Seroquel XR Quetiapine Fumarate TABLET, EXTENDED RELEASE;ORAL 022047 ASTRAZENECA 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022047s033s037lbl.pdf#page=52
Seroquel XR Quetiapine Fumarate TABLET, EXTENDED RELEASE;ORAL 022047 ASTRAZENECA 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022047s040lbl.pdf#page=52
Seroquel XR Quetiapine Fumarate TABLET, EXTENDED RELEASE;ORAL 022047 ASTRAZENECA 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047Orig1s042lbl.pdf#page=52
Seroquel XR Quetiapine Fumarate TABLET, EXTENDED RELEASE;ORAL 022047 ASTRAZENECA 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022047s041s044lbl.pdf#page=52
Signifor Pasireotide Diaspartate SOLUTION;SUBCUTANEOUS 200677 RECORDATI RARE 01/15/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM332633.pdf
Signifor Pasireotide Diaspartate SOLUTION;SUBCUTANEOUS 200677 RECORDATI RARE 01/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s005lbl.pdf#page=16
Signifor Pasireotide Diaspartate SOLUTION;SUBCUTANEOUS 200677 RECORDATI RARE 01/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200677s006lbl.pdf#page=15
Signifor LAr Kit Pasireotide Pamoate FOR SUSPENSION;INTRAMUSCULAR 203255 RECORDATI RARE 07/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf#page=27
Siklos Hydroxyurea TABLET;ORAL 208843 ADDMEDICA SAS 05/22/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208843s002lbl.pdf#page=17
Siklos Hydroxyurea TABLET;ORAL 208843 ADDMEDICA SAS 05/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf#page=17
Silenor Doxepin Hydrochloride TABLET;ORAL 022036 CURRAX 10/29/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206668.pdf
Siliq Brodalumab INJECTABLE;INJECTION 761032 VALEANT LUXEMBOURG 10/09/2018 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 09/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf#page=28
Simponi Aria Golimumab INJECTABLE; INJECTION 125433 JANSSEN BIOTECH 09/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125433s028lbl.pdf#page=31
Simponi Aria Golimumab INJECTABLE; INJECTION 125433 JANSSEN BIOTECH 09/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125433s030s031lbl.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 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020829s073,020830s075,021409s051lbl.pdf#page=22
Singulair Montelukast Sodium TABLET, CHEWABLE;ORAL 020830 MSD MERCK CO 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020829s073,020830s075,021409s051lbl.pdf#page=22
Singulair Montelukast Sodium GRANULE;ORAL 021409 MERCK 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020829s073,020830s075,021409s051lbl.pdf#page=22
Sirturo Bedaquiline Fumarate TABLET;ORAL 204384 JANSSEN THERAP 05/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204384s011lbl.pdf#page=24
Sirturo Bedaquiline Fumarate TABLET;ORAL 204384 JANSSEN THERAP 05/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204384s014lbl.pdf#page=24
Skyrizi Risankizumab-Rzaa INJECTABLE;INJECTION 761105 ABBVIE INC 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf#page=12
Skyrizi Risankizumab-Rzaa INJECTABLE;INJECTION 761105 ABBVIE INC 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf#page=13
Sodium Oxybate Sodium Oxybate SOLUTION;ORAL 202090 HIKMA 01/17/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18
Solaraze Diclofenac Sodium GEL;TOPICAL 021005 FOUGERA PHARMS 05/16/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf
Soliqua 100/33 Insulin Glargine; Lixisenatide SOLUTION;SUBCUTANEOUS 208673 SANOFI-AVENTIS US 11/15/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208673s008s009lbl.pdf#page=30
Soliris Eculizumab INJECTABLE; IV (INFUSION) 125166 ALEXION PHARM 11/20/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166Orig1s427s428MedGuide.pdf
Soliris Eculizumab INJECTABLE; IV (INFUSION) 125166 ALEXION PHARM 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf#page=40
Soltamox Tamoxifen Citrate SOLUTION;ORAL 021807 MAYNE PHARMA INC 04/08/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lblMG.pdf
Soltamox Tamoxifen Citrate SOLUTION;ORAL 021807 MAYNE PHARMA INC 04/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf#page=36
Soltamox Tamoxifen Citrate SOLUTION;ORAL 021807 MAYNE PHARMA INC 04/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf#page=36
Sonata Zaleplon CAPSULE;ORAL 020859 PFIZER 08/18/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM349707.pdf
Sonata Zaleplon CAPSULE;ORAL 020859 PFIZER 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s015lbl.pdf#page=21
Sonata Zaleplon CAPSULE;ORAL 020859 PFIZER 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf#page=21
Soriatane Acitretin CAPSULE;ORAL 019821 STIEFEL LABS INC 09/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018mg.pdf
Sotret Isotretinoin CAPSULE;ORAL 076041 SUN PHARM INDS LTD 04/12/2012 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Sotret.pdf
Spravato Esketamine Hydrochloride SPRAY;NASAL 211243 JANSSEN PHARMS 07/31/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf#page=42
Spritam Levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 APRECIA PHARMS 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf#page=36
Spritam Levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 APRECIA PHARMS 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf#page=34
Sprix Ketorolac Tromethamine SPRAY, METERED;NASAL 022382 ZYLA 01/22/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf#page=20
Steglatro Ertugliflozin TABLET;ORAL 209803 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf#page=24
Steglatro Ertugliflozin TABLET;ORAL 209803 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf#page=25
Steglatro Ertugliflozin TABLET;ORAL 209803 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209803s002lbl.pdf#page=25
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf#page=32
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf#page=32
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209805s005lbl.pdf#page=32
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209805s006lbl.pdf#page=32
Stelara Ustekinumab INJECTABLE; INJECTION 125261 CENTOCOR ORTHO BIOTECH INC 12/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf#page=36
Stelara Ustekinumab INJECTABLE;INJECTION 761044 JANSSEN BIOTECH 12/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf#page=36
Strattera Atomoxetine Hydrochloride CAPSULE;ORAL 021411 LILLY 02/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf#page=19
Strattera Atomoxetine Hydrochloride CAPSULE;ORAL 021411 LILLY 02/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021411s049lbl.pdf#page=21
Striverdi Respimat Olodaterol Hydrochloride SPRAY, METERED;INHALATION 203108 BOEHRINGER INGELHEIM 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/striverdi respimatMedGuide2016.pdf
Sublocade Buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 INDIVIOR INC 06/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209819s012lbl.pdf#page=41
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 020733 INDIVIOR INC 03/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020733s024lbl.pdf#page=30
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 INDIVIOR INC 03/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 INDIVIOR INC 03/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022410s038lbl.pdf#page=32
Subsys Fentanyl SPRAY;SUBLINGUAL 202788 BTCP PHARMA 10/07/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf#page=38