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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

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Drug Name Active Ingredient Form;Route Appl. No. Company Date Link
Drug Name Active Ingredient Form;Route Appl. No. Company Date Link
Abilify Aripiprazole TABLET;ORAL 021436 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Aripiprazole SOLUTION;ORAL 021713 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Aripiprazole INJECTABLE;INTRAMUSCULAR 021866 OTSUKA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77
Abilify Maintena Kit Aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 OTSUKA PHARM CO LTD 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf#page=52
Abilify Mycite Kit Aripiprazole TABLET;ORAL 207202 OTSUKA 12/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207202s003lbl.pdf#page=44
Abrilada Adalimumab-Afzb INJECTABLE;INJECTION 761118 PFIZER INC 07/29/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761118s006lbl.pdf#page=44
Absorica Isotretinoin CAPSULE;ORAL 021951 SUN PHARM INDS INC 10/08/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021951s013lbl.pdf#page=32
Abstral Fentanyl Citrate TABLET;SUBLINGUAL 022510 SENTYNL THERAPS INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf#page=29
Accutane Isotretinoin CAPSULE;ORAL 018662 HOFFMANN LA ROCHE 10/22/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedGuide.pdf
Aciphex Rabeprazole Sodium TABLET, DELAYED RELEASE;ORAL 020973 WOODWARD 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020973s042lbl.pdf#page=34
Aciphex Sprinkle Rabeprazole Sodium CAPSULE, DELAYED RELEASE;ORAL 204736 AYTU 11/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf#page=21
Actemra Tocilizumab INJECTABLE; INJECTION 125276 GENENTECH 02/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s134lbl.pdf#page=50
Actemra Tocilizumab INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 125472 GENENTECH 02/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s046lbl.pdf#page=50
Acthar Gel Corticotropin INJECTABLE;INJECTION 008372 MALLINCKRODT ARD 10/29/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s071lbl.pdf#page=17
Actiq Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747 CEPHALON 12/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020747s053lbl.pdf#page=43
Actonel Risedronate Sodium TABLET;ORAL 020835 APIL 11/05/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020835s052lbl.pdf#page=38
Actonel With Calcium (Copackaged) Calcium Carbonate; Risedronate Sodium TABLET;ORAL 021823 WARNER CHILCOTT 04/08/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf#page=27
Actoplus MET Metformin Hydrochloride; Pioglitazone Hydrochloride TABLET;ORAL 021842 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf#page=41
Actoplus MET XR Metformin Hydrochloride; Pioglitazone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf#page=41
Actos Pioglitazone Hydrochloride TABLET;ORAL 021073 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35
Adasuve Loxapine POWDER;INHALATION 022549 ALEXZA PHARMS 02/01/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf#page=28
Adderall 10 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall 12.5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall 15 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall 20 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall 30 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall 5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall 7.5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15
Adderall XR 10 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021303s036lbl.pdf#page=23
Adderall XR 15 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 20 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 25 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 30 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Adderall XR 5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 TAKEDA PHARMS USA 07/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24
Addyi Flibanserin TABLET;ORAL 022526 SPROUT PHARMS 04/11/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf#page=23
Adempas Riociguat TABLET;ORAL 204819 BAYER HLTHCARE 09/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204819s015lbl.pdf#page=24
Adhansia XR Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038 PURDUE PHARMA LP 06/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf#page=25
Adlyxin Lixisenatide SOLUTION;SUBCUTANEOUS 208471 SANOFI-AVENTIS US 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf#page=24
Adzenys ER Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325 NEOS THERAPS INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204325s003lbl.pdf#page=26
Adzenys XR-Odt Amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326 NEOS THERAPS 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf#page=26
Afrezza Insulin Recombinant Human POWDER;INHALATION 022472 MANNKIND 10/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf#page=12
Alkindi Sprinkle Hydrocortisone GRANULE;ORAL 213876 ETON 02/03/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213876s001lbl.pdf#page=14
Ambien Zolpidem Tartrate TABLET;ORAL 019908 SANOFI AVENTIS US 02/23/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf#page=24
Ambien CR Zolpidem Tartrate TABLET, EXTENDED RELEASE;ORAL 021774 SANOFI AVENTIS US 02/23/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf#page=27
Amjevita Adalimumab-Atto INJECTABLE;INJECTION 761024 AMGEN INC 07/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761024s010lbl.pdf#page=46
Ampyra Dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250 ACORDA 11/18/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s019lbl.pdf#page=13
Anafranil Clomipramine Hydrochloride CAPSULE;ORAL 019906 SPECGX LLC 05/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019906s043lbl.pdf#page=27
Anaprox Naproxen Sodium TABLET;ORAL 018164 ATNAHS PHARMA US 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf#page=23
Anaprox DS Naproxen Sodium TABLET;ORAL 018164 ATNAHS PHARMA US 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf#page=23
Androgel Testosterone GEL;TRANSDERMAL 021015 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf#page=23
Androgel Testosterone GEL, METERED;TRANSDERMAL 021015 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021015s045lbl.pdf#page=23
Androgel Testosterone GEL, METERED;TRANSDERMAL 022309 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf#page=25
Androgel Testosterone GEL;TRANSDERMAL 022309 ABBVIE 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022309s020lbl.pdf#page=25
Ansaid Flurbiprofen TABLET;ORAL 018766 PHARMACIA AND UPJOHN 05/09/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf
Apadaz Acetaminophen; Benzhydrocodone Hydrochloride TABLET;ORAL 208653 KVK TECH INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208653s007lbl.pdf#page=38
Aplenzin Bupropion Hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108 BAUSCH 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022108s022lbl.pdf#page=29
Aptensio XR Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 RHODES PHARMS 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205831s006lbl.pdf#page=17
Aptiom Eslicarbazepine Acetate TABLET;ORAL 022416 SUNOVION PHARMS INC 03/15/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022416s011lbl.pdf#page=25
Aranesp Darbepoetin Alfa VIAL; INTRAVENOUS 103951 AMGEN 01/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25
Aranesp Darbepoetin Alfa VIAL; SUBCUTANEOUS 103951 AMGEN 01/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25
Arcapta Neohaler Indacaterol Maleate POWDER;INHALATION 022383 NOVARTIS 07/30/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf
Arikayce Kit Amikacin Sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356 INSMED INC 10/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf#page=15
Aristada Aripiprazole LAuroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533 ALKERMES INC 03/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=36
Aristada Initio Kit Aripiprazole LAuroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830 ALKERMES INC 03/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=72
Arthrotec Diclofenac Sodium; Misoprostol TABLET, DELAYED RELEASE;ORAL 020607 PFIZER 08/02/2021 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
Astagraf XL Tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096 ASTELLAS 12/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204096s009lbl.pdf#page=31
Atelvia Risedronate Sodium TABLET, DELAYED RELEASE;ORAL 022560 APIL 08/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022560s011lbl.pdf#page=24
Ativan Lorazepam TABLET;ORAL 017794 BAUSCH 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017794s048lbl.pdf#page=13
Aubagio Teriflunomide TABLET;ORAL 202992 SANOFI AVENTIS US 04/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf#page=25
Austedo Deutetrabenazine TABLET;ORAL 208082 TEVA BRANDED PHARM 05/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208082s011lbl.pdf#page=25
Avandamet Metformin Hydrochloride; Rosiglitazone Maleate TABLET;ORAL 021410 SB PHARMCO 04/05/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf#page=38
Avandaryl Glimepiride; Rosiglitazone Maleate TABLET;ORAL 021700 SB PHARMCO 12/16/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf#page=39
Avandia Rosiglitazone Maleate TABLET;ORAL 021071 WOODWARD 02/05/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf#page=38
Aveed Testosterone Undecanoate INJECTABLE;INTRAMUSCULAR 022219 ENDO PHARMS INC 08/16/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022219s014lbl.pdf#page=23
Avelox Moxifloxacin Hydrochloride TABLET;ORAL 021085 BAYER HLTHCARE 07/26/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33
Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 021277 BAYER HLTHCARE 09/27/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33
Avinza Morphine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021260 KING PHARMS LLC 06/26/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311346.pdf
Avonex Interferon Beta-1a VIAL 103628 BIOGEN 11/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103628s5266lbl.pdf#page=22
Avsola Infliximab-Axxq INJECTABLE;INJECTION 761086 AMGEN INC 09/09/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761086s000lbl.pdf#page=48
Axiron Testosterone SOLUTION, METERED;TRANSDERMAL 022504 ELI LILLY AND CO 07/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf#page=15
Azstarys Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride CAPSULE;ORAL 212994 COMMAVE THERAP 03/02/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212994s000lbl.pdf#page=26
Banzel Rufinamide SUSPENSION;ORAL 201367 EISAI INC 11/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19
Banzel Rufinamide TABLET;ORAL 021911 EISAI INC 11/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf#page=19
Bavencio Avelumab INJECTABLE;INTRAVENOUS 761078 EMD SERONO INC 05/09/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf#page=23
Bavencio Avelumab INJECTABLE;INJECTION 761049 EMD SERONO INC 07/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf#page=36
Baxdela Delafloxacin Meglumine TABLET;ORAL 208610 MELINTA 06/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28
Baxdela Delafloxacin Meglumine POWDER;INTRAVENOUS 208611 MELINTA 06/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208610s007,208611s006lbl.pdf#page=28
Belbuca Buprenorphine Hydrochloride FILM;BUCCAL 207932 BDSI 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207932s019s020lbl.pdf#page=38
Belsomra Suvorexant TABLET;ORAL 204569 MERCK SHARP DOHME 03/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204569s008lbl.pdf#page=23
Benlysta Belimumab INJECTABLE;INJECTION 761043 GLAXOSMITHKLINE LLC 07/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761043s021lbl.pdf#page=41
Benlysta Belimumab INJECTABLE; INJECTION 125370 HUMAN GENOME SCIENCES INC. 07/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125370s078lbl.pdf#page=41
Besremi Ropeginterferon Alfa-2b-Njft INJECTABLE;SUBCUTANEOUS 761166 PHARMAESSENTIA CORP 11/12/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf#page=18
Betaseron Interferon Beta-1b VIAL; SUBCUTANEOUS 103471 BAYER HEALTHCARE PHARMS 11/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103471s5200lbl.pdf#page=19
Bevyxxa Betrixaban CAPSULE;ORAL 208383 PORTOLA PHARMS INC 08/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20
Binosto Alendronate Sodium TABLET, EFFERVESCENT;ORAL 202344 ASCEND THERAPS US 10/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf#page=33
Blenrep Belantamab Mafodotin-Blmf INJECTABLE;INTRAVENOUS 761158 GLAXOSMITHKLINE 02/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761158s006lbl.pdf#page=22
Blincyto Blinatumomab INJECTABLE;INJECTION 125557 AMGEN 02/18/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf#page=40
Boniva Ibandronate Sodium INJECTABLE;INTRAVENOUS 021858 ROCHE 01/11/2022 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18
Boniva Ibandronate Sodium TABLET;ORAL 021455 HOFFMANN LA ROCHE 12/07/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf#page=19
Bonsity Teriparatide SOLUTION;SUBCUTANEOUS 211939 ALVOGEN 10/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211939s000lbl.pdf#page=25
Botox Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 04/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5320lbl.pdf#page=51
Botox Cosmetic Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 04/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103000s5320lbl.pdf#page=51
Braftovi Encorafenib CAPSULE;ORAL 210496 ARRAY BIOPHARMA INC 02/11/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210496s013lbl.pdf#page=22
Brilinta Ticagrelor TABLET;ORAL 022433 ASTRAZENECA 05/09/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022433s034lbl.pdf#page=35
Brisdelle Paroxetine Mesylate CAPSULE;ORAL 204516 SEBELA IRELAND LTD 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204516s011lbl.pdf#page=16
Briviact Brivaracetam TABLET;ORAL 205836 UCB INC 02/18/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.pdf#page=17
Briviact Brivaracetam SOLUTION;INTRAVENOUS 205837 UCB INC 02/18/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.pdf#page=17
Briviact Brivaracetam SOLUTION;ORAL 205838 UCB INC 02/18/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.pdf#page=17
Brovana Arformoterol Tartrate SOLUTION;INHALATION 021912 SUNOVION 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf#page=22
Bunavail Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL 205637 BDSI 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf#page=33
Butrans Buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 PURDUE PHARMA LP 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021306s039lbl.pdf#page=43
Bydureon Exenatide Synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 ASTRAZENECA AB 07/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf#page=36
Bydureon Bcise Exenatide Synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 ASTRAZENECA AB 07/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s019lbl.pdf#page=33
Bydureon Pen Exenatide Synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 ASTRAZENECA AB 07/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf#page=36
Byetta Exenatide Synthetic INJECTABLE; SUBCUTANEOUS 021919 AMYLIN 10/30/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf
Byetta Exenatide Synthetic INJECTABLE;SUBCUTANEOUS 021773 ASTRAZENECA AB 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s046s047lbl.pdf#page=33
Cambia Diclofenac Potassium FOR SOLUTION;ORAL 022165 ASSERTIO 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf#page=23
Caplyta Lumateperone Tosylate CAPSULE;ORAL 209500 INTRA-CELLULAR 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209500s009lbl.pdf#page=22
Caprelsa Vandetanib TABLET;ORAL 022405 GENZYME CORP 03/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022405s019lbl.pdf#page=20
Carbatrol Carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712 TAKEDA PHARMS USA 12/01/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf
Cassipa Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;SUBLINGUAL 208042 TEVA PHARMS USA 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208042s005s007lbl.pdf#page=30
Cataflam Diclofenac Potassium TABLET;ORAL 020142 NOVARTIS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020142s029lbl.pdf#page=19
Celebrex Celecoxib CAPSULE;ORAL 020998 UPJOHN 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf#page=22
Celebrex Celecoxib CAPSULE;ORAL 021156 GD SEARLE LLC 02/04/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003MedG.pdf
Celexa Citalopram Hydrobromide SOLUTION;ORAL 021046 FOREST LABS 12/03/2012 https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf#page=32
Celexa Citalopram Hydrobromide TABLET;ORAL 020822 ALLERGAN 02/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020822s042,021046s019lbl.pdf#page=32
Cellcept Mycophenolate Mofetil CAPSULE;ORAL 050722 ROCHE PALO 06/06/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf#page=39
Cellcept Mycophenolate Mofetil TABLET;ORAL 050723 ROCHE PALO 06/06/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf#page=39
Cellcept Mycophenolate Mofetil Hydrochloride INJECTABLE;INJECTION 050758 ROCHE PALO 06/06/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s049s051,050723s049s051,050758s047s049lbl.pdf#page=39
Cellcept Mycophenolate Mofetil FOR SUSPENSION;ORAL 050759 ROCHE PALO 10/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050722s040,050723s041,050758s037,050759s045lbl.pdf#page=38
Celontin Methsuximide CAPSULE;ORAL 010596 PARKE DAVIS 06/15/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf
Cerdelga Eliglustat Tartrate CAPSULE;ORAL 205494 GENZYME CORP 08/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf#page=19
Chantix Varenicline Tartrate TABLET;ORAL 021928 PF PRISM CV 02/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22
Chlordiazepoxide and Amitriptyline Hydrochloride Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 071297 MYLAN PHARMS INC 02/05/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf
Cibinqo Abrocitinib TABLET; ORAL 213871 PFIZER INC 01/14/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213871s000lbl.pdf#page=26
Cimzia Certolizumab Pegol INJECTABLE; INJECTION 125160 UCB INC 09/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125160s293lbl.pdf#page=41
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 03/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847s063lbl.pdf#page=33
Cipro Ciprofloxacin Hydrochloride TABLET;ORAL 019537 BAYER HLTHCARE 07/26/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s092lbl.pdf#page=39
Cipro Ciprofloxacin FOR SUSPENSION;ORAL 020780 BAYER HLTHCARE 07/26/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s093,020780s049lbl.pdf#page=40
Cipro in Dextrose 5% in Plastic Container Ciprofloxacin INJECTABLE;INJECTION 019857 BAYER HLTHCARE 03/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019857s073lbl.pdf#page=33
Cipro XR Ciprofloxacin; Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 BAYER HLTHCARE 07/26/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021473s043lbl.pdf#page=30
Citalopram Citalopram Hydrobromide CAPSULE; ORAL 215428 ALMATICA 01/31/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215428s000lbl.pdf#page=23
Clenpiq Citric Acid; Magnesium Oxide; Sodium Picosulfate SOLUTION;ORAL 209589 FERRING PHARMS INC 10/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209589s006lbledt.pdf#page=14
Clinoril Sulindac TABLET;ORAL 017911 MERCK 12/23/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf
Codeine Sulfate Codeine Sulfate TABLET;ORAL 022402 HIKMA 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf#page=29
Codeine Sulfate Codeine Sulfate SOLUTION;ORAL 202245 HIKMA 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202245s009lbl.pdf#page=29
Colcrys Colchicine TABLET; ORAL 022353 AR HOLDING CO INC 10/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf#page=19
Colcrys Colchicine TABLET;ORAL 022352 TAKEDA PHARMS USA 05/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf#page=25
Combunox Ibuprofen; Oxycodone Hydrochloride TABLET;ORAL 021378 FOREST LABS 09/02/2010 https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021378s006lbl.pdf#page=30
Concerta Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 JANSSEN PHARMS 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021121s044lbl.pdf#page=30
Consensi Amlodipine Besylate; Celecoxib TABLET;ORAL 210045 PURPLE BIOTECH 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210045s009lbl.pdf#page=10
Contrave Bupropion Hydrochloride; Naltrexone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063 NALPROPION 04/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200063s020lbl.pdf#page=40
Conzip Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022370 CIPHER PHARMS INC 09/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022370s023lbl.pdf#page=35
Copegus Ribavirin TABLET;ORAL 021511 ROCHE 08/11/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf#page=27
Copiktra Duvelisib CAPSULE;ORAL 211155 SECURA 12/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s005lbl.pdf#page=28
Cordarone Amiodarone Hydrochloride TABLET;ORAL 018972 WYETH PHARMS 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf#page=13
Corlanor Ivabradine SOLUTION;ORAL 209964 AMGEN INC 08/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf#page=24
Corlanor Ivabradine Hydrochloride TABLET;ORAL 206143 AMGEN INC 08/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206143s008,209964s002lblrpl.pdf#page=24
Cosentyx Secukinumab INJECTABLE;INJECTION 125504 NOVARTIS PHARMS CORP 12/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf#page=24
Cotempla XR-Odt Methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NEOS THERAPS INC 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205489s007lbl.pdf#page=22
Coumadin Warfarin Sodium INJECTABLE;INJECTION 009218 BRISTOL MYERS SQUIBB 08/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30
Coumadin Warfarin Sodium TABLET;ORAL 009218 BRISTOL MYERS SQUIBB 08/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30
Creon Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 020725 ABBVIE 06/02/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020725s028lbl.pdf#page=16
Cyltezo Adalimumab-Adbm INJECTABLE;INJECTION 761058 BOEHRINGER INGELHEIM 10/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761058s008lbl.pdf#page=33
Cymbalta Duloxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 LILLY 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021427s056lbl.pdf#page=38
Daliresp Roflumilast TABLET;ORAL 022522 ASTRAZENECA 01/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf#page=17
Dalmane Flurazepam Hydrochloride CAPSULE;ORAL 016721 VALEANT PHARM INTL 03/27/2009 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
Darvocet-N 100 Acetaminophen; Propoxyphene Napsylate TABLET;ORAL 017122 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf
Darvocet-N 50 Acetaminophen; Propoxyphene Napsylate TABLET;ORAL 017122 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf
Darvon Propoxyphene Hydrochloride CAPSULE;ORAL 010997 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf
Darvon-N Propoxyphene Napsylate TABLET;ORAL 016862 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf
Daurismo Glasdegib Maleate TABLET;ORAL 210656 PFIZER 03/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf#page=20
Daypro Oxaprozin TABLET;ORAL 018841 PFIZER 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018841s033lbl.pdf#page=25
Daypro Alta Oxaprozin Potassium TABLET;ORAL 020776 PFIZER 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020776s010lbl.pdf#page=22
Daytrana Methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NOVEN PHARMS INC 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021514s032lbl.pdf#page=25
Dayvigo Lemborexant TABLET;ORAL 212028 EISAI INC 03/11/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212028s006lbl.pdf#page=21
Demerol Meperidine Hydrochloride TABLET;ORAL 005010 VALIDUS PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32
Demerol Meperidine Hydrochloride INJECTABLE;INJECTION 005010 VALIDUS PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32
Demerol Meperidine Hydrochloride SYRUP;ORAL 005010 VALIDUS PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005010s059lbl.pdf#page=32
Depakene Valproic Acid CAPSULE;ORAL 018081 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018081s070,018082s053lbl.pdf#page=41
Depakene Valproic Acid SYRUP;ORAL 018082 ABBVIE 05/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018081Orig1s068%20018082Orig1s051lbl.pdf#page=38
Depakote Divalproex Sodium TABLET, DELAYED RELEASE;ORAL 018723 ABBVIE 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018723s065lbl.pdf#page=48
Depakote Divalproex Sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680 ABBVIE 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019680s052lbl.pdf#page=42
Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE;ORAL 021168 ABBVIE 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021168s043lbl.pdf#page=48
Descovy Emtricitabine; Tenofovir Alafenamide Fumarate TABLET;ORAL 208215 GILEAD SCIENCES INC 01/07/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf#page=37
Desoxyn Methamphetamine Hydrochloride TABLET;ORAL 005378 RECORDATI RARE 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf#page=12
Desoxyn Methamphetamine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378 RECORDATI RARE 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf#page=12
Desvenlafaxine Desvenlafaxine Fumarate TABLET, EXTENDED RELEASE;ORAL 205208 TEVA PHARMS USA 07/18/2014 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205208Orig1s001lbl.pdf#page=23
Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204150 ALEMBIC PHARMS LTD 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204150s018lbl.pdf#page=32
Desyrel Trazodone Hydrochloride TABLET;ORAL 018207 PRAGMA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf#page=13
Desyrel Trazodone Hydrochloride TABLET;ORAL 018207 PRAGMA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf#page=14
Dexedrine Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 IMPAX LABS INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017078s054lbl.pdf#page=14
Dexilant Dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287 TAKEDA PHARMS USA 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022287s035lbl.pdf#page=24
Dextroamphetamine Sulfate Dextroamphetamine Sulfate SOLUTION;ORAL 040776 OUTLOOK PHARMS 01/04/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/40776MG.pdf#page=7
Diacomit Stiripentol FOR SUSPENSION;ORAL 207223 BIOCODEX SA 08/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17
Diacomit Stiripentol CAPSULE;ORAL 206709 BIOCODEX SA 08/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17
Dilantin Phenytoin Sodium CAPSULE;ORAL 084349 UPJOHN 10/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf#page=21
Dilantin Phenytoin TABLET, CHEWABLE;ORAL 084427 PHARMACIA 10/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf#page=17
Dilantin-125 Phenytoin SUSPENSION;ORAL 008762 UPJOHN 03/03/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf#page=19
Dilantin-30 Phenytoin SUSPENSION;ORAL 008762 UPJOHN 03/03/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf#page=19
Dilaudid Hydromorphone Hydrochloride SOLUTION;ORAL 019891 RHODES PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf#page=30
Dilaudid Hydromorphone Hydrochloride TABLET;ORAL 019892 RHODES PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf#page=30
Dolophine Hydrochloride Methadone Hydrochloride SYRUP;ORAL 006134 HIKMA 06/02/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf#page=36
Dolophine Hydrochloride Methadone Hydrochloride TABLET;ORAL 006134 HIKMA 06/02/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf#page=36
Doral Quazepam TABLET;ORAL 018708 GALT PHARMS 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018708s027lbl.pdf#page=9
Dotarem Gadoterate Meglumine SOLUTION;INTRAVENOUS 204781 GUERBET 07/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204781s012lbl.pdf#page=17
Drizalma Sprinkle Duloxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516 SUN PHARMA GLOBAL 07/23/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212516s002lbl.pdf#page=46
Droxia Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 07/22/2019 http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016295s056MG.pdf
Duetact Glimepiride; Pioglitazone Hydrochloride TABLET;ORAL 021925 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf#page=39
Duexis Famotidine; Ibuprofen TABLET;ORAL 022519 HORIZON 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf#page=25
Duragesic-100 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52
Duragesic-12 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52
Duragesic-25 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52
Duragesic-37 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52
Duragesic-50 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52
Duragesic-75 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52
Duzallo Allopurinol; Lesinurad TABLET;ORAL 209203 IRONWOOD PHARMS INC 08/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209203s000lbl.pdf#page=27
Dyanavel XR Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147 TRIS PHARMA INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25
Dyanavel XR 10 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate TABLET, EXTENDED RELEASE;ORAL 210526 TRIS PHARMA INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25
Dyanavel XR 15 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate TABLET, EXTENDED RELEASE;ORAL 210526 TRIS PHARMA INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25
Dyanavel XR 20 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate TABLET, EXTENDED RELEASE;ORAL 210526 TRIS PHARMA INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25
Dyanavel XR 5 Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate TABLET, EXTENDED RELEASE;ORAL 210526 TRIS PHARMA INC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25
Dysport Abobotulinumtoxina INJECTABLE; INJECTION 125274 IPSEN BIOPHARM LTD 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 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf#page=23
Edluar Zolpidem Tartrate TABLET;SUBLINGUAL 021997 MYLAN SPECIALITY LP 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf#page=23
Effexor Venlafaxine Hydrochloride TABLET;ORAL 020151 WYETH PHARMS INC 12/12/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf#page=34
Effexor XR Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699 UPJOHN 11/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf#page=49
Effient Prasugrel Hydrochloride TABLET;ORAL 022307 DAIICHI SANKYO INC 12/22/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022307s018lbl.pdf#page=21
Elepsia XR Levetiracetam TABLET, EXTENDED RELEASE;ORAL 204417 TRIPOINT 12/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204417s004lbl.pdf#page=25
Elidel Pimecrolimus CREAM;TOPICAL 021302 BAUSCH 06/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088587.pdf
Eliquis Apixaban TABLET;ORAL 202155 BRISTOL MYERS SQUIBB 10/12/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202155s034lbl.pdf#page=38
Elmiron Pentosan Polysulfate Sodium CAPSULE;ORAL 020193 JANSSEN PHARMS 03/12/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193s015lbl.pdf#page=11
Elyxyb Celecoxib SOLUTION;ORAL 212157 BDSI 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf#page=24
Embeda Morphine Sulfate; Naltrexone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 ALPHARMA PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf#page=30
Emsam Selegiline FILM, EXTENDED RELEASE;TRANSDERMAL 021336 SOMERSET 07/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf#page=34
Enbrel Etanercept VIAL; SUBCUTANEOUS 103795 IMMUNEX 02/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35
Enbrel Etanercept SYRINGE 103795 IMMUNEX 02/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf#page=35
Enhertu Fam-Trastuzumab Deruxtecan-Nxki INJECTABLE;INJECTION 761139 DAIICHI SANKYO 08/11/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s022lbl.pdf#page=31
Enjaymo Sutimlimab-Jome INJECTABLE;INJECTION 761164 BIOVERATIV THERAPEUTICS INC 02/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf#page=13
Entyvio Vedolizumab INJECTABLE;INJECTION 125476 TAKEDA PHARMS USA 08/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf#page=20
Envarsus XR Tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406 VELOXIS PHARMS INC 09/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206406s007lbl.pdf#page=29
Eovist Gadoxetate Disodium SOLUTION;INTRAVENOUS 022090 BAYER HLTHCARE 12/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090s020lbledt.pdf#page=15
Epidiolex Cannabidiol SOLUTION;ORAL 210365 GW RES LTD 02/24/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210365s015lbl.pdf#page=32
Epogen Epoetin Alfa VIAL; SINGLE-USE 103234 AMGEN 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27
Epzicom Abacavir Sulfate; LAmivudine TABLET;ORAL 021652 VIIV HLTHCARE 12/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s029lbl.pdf#page=28
Equetro Carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710 VALIDUS PHARMS 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/2020/203388s016lbl.pdf#page=14
Esomeprazole Strontium Esomeprazole Strontium CAPSULE, DELAYED RELEASE;ORAL 202342 BELCHER 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202342s007lbl.pdf#page=29
Estazolam Estazolam TABLET;ORAL 074921 MAYNE PHARMA 02/05/2021 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359235.pdf
Eticovo Etanercept-Ykro INJECTABLE;INJECTION 761066 SAMSUNG BIOEPIS CO LTD 04/25/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf#page=31
Evekeo ODT Amphetamine Sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905 ARBOR PHARMS LLC 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s002lbl.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 022042 LILLY 09/13/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
Evista Raloxifene Hydrochloride TABLET;ORAL 020815 LILLY 06/27/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
Exalgo Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217 SPECGX LLC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf#page=31
Exjade Deferasirox TABLET, FOR SUSPENSION;ORAL 021882 NOVARTIS 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021882s033lbl.pdf#page=28
Extavia Interferon Beta-1b INJECTABLE; SUBCUTANEOUS 125290 NOVARTIS PHARMS 11/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125290s073lbl.pdf#page=16
Factive Gemifloxacin Mesylate TABLET;ORAL 021158 LG CHEM LTD 07/26/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021158s026lbl.pdf#page=30
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 04/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf#page=50
Farydak Panobinostat LActate CAPSULE;ORAL 205353 SECURA 06/06/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf
Felbatol Felbamate TABLET;ORAL 020189 MYLAN SPECIALITY LP 08/31/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf
Felbatol Felbamate SUSPENSION;ORAL 020189 MYLAN SPECIALITY LP 08/31/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf
Feldene Piroxicam CAPSULE;ORAL 018147 PFIZER 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf#page=21
Fensolvi Kit Leuprolide Acetate POWDER;SUBCUTANEOUS 213150 TOLMAR 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s002lbl.pdf#page=15
Fentanyl Citrate Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312 PAR PHARM 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf
Fentanyl Citrate Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907 SPECGX LLC 12/03/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf
Fentora Fentanyl Citrate TABLET;BUCCAL, SUBLINGUAL 021947 CEPHALON 12/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021947s034lbl.pdf#page=42
Ferriprox Deferiprone TABLET;ORAL 021825 CHIESI 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf#page=17
Ferriprox Deferiprone TABLET;ORAL 212269 CHIESI 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212269s003lbl.pdf#page=17
Ferriprox Deferiprone SOLUTION;ORAL 208030 CHIESI 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s007lbl.pdf#page=13
Fetzima Levomilnacipran Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 ALLERGAN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204168s007lbl.pdf#page=28
Fintepla Fenfluramine Hydrochloride SOLUTION;ORAL 212102 ZOGENIX INC 06/16/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s005lbl.pdf#page=30
Fioricet W/ Codeine Acetaminophen; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 020232 ACTAVIS LABS UT INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf#page=42
Fiorinal W/Codeine Aspirin; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 019429 ALLERGAN 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf#page=39
Firdapse Amifampridine Phosphate TABLET;ORAL 208078 CATALYST PHARMS 03/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf#page=11
Flector Diclofenac Epolamine SYSTEM;TOPICAL 021234 INST BIOCHEM 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021234s019lbl.pdf#page=24
Flowtuss Guaifenesin; Hydrocodone Bitartrate SOLUTION;ORAL 022424 BKK PHARMS 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf#page=26
Floxin Ofloxacin TABLET;ORAL 019735 JANSSEN PHARMS 02/25/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf
Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET;ORAL 202133 ALMATICA 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202133s012lbl.pdf#page=35
Focalin Dexmethylphenidate Hydrochloride TABLET;ORAL 021278 NOVARTIS 06/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021278s029lbl.pdf#page=15
Focalin XR Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NOVARTIS 06/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021802s039lbl.pdf#page=18
Foradil Formoterol Fumarate POWDER;INHALATION 020831 NOVARTIS 03/02/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf
Foradil Certihaler Formoterol Fumarate POWDER;INHALATION 021592 NOVARTIS 06/02/2010 https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021592s003lbl.pdf#page=35
Forfivo XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 ALMATICA 12/10/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022497s008lbl.pdf#page=33
Forteo Teriparatide SOLUTION;SUBCUTANEOUS 021318 LILLY 09/07/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf#page=16
Fortesta Testosterone GEL, METERED;TRANSDERMAL 021463 ENDO PHARMS 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021463s025lbl.pdf#page=21
Fosamax Alendronate Sodium SOLUTION;ORAL 021575 MERCK 11/30/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24
Fosamax Alendronate Sodium TABLET;ORAL 020560 MERCK AND CO INC 08/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24
Fosamax Plus D Alendronate Sodium; Cholecalciferol TABLET;ORAL 021762 ORGANON 08/16/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf
Fosamax Plus D Alendronate Sodium; Cholecalciferol TABLET;ORAL 021762 ORGANON 08/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021762s022lbl.pdf#page=23
Fosrenol Lanthanum Carbonate TABLET, CHEWABLE;ORAL 021468 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf#page=12
Fosrenol Lanthanum Carbonate POWDER;ORAL 204734 TAKEDA PHARMS USA 05/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf#page=12
Fycompa Perampanel TABLET;ORAL 202834 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf#page=24
Fycompa Perampanel SUSPENSION;ORAL 208277 EISAI INC 05/30/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf#page=24
Gabitril Tiagabine Hydrochloride TABLET;ORAL 020646 CEPHALON 08/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229203.pdf
Gadavist Gadobutrol SOLUTION;INTRAVENOUS 201277 BAYER HLTHCARE 04/27/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201277s020lbl.pdf#page=42
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 02/11/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203441s018lbl.pdf#page=17
Gilenya Fingolimod Hydrochloride CAPSULE;ORAL 022527 NOVARTIS 12/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022527s029s030lbl.pdf#page=26
Gimoti Metoclopramide Hydrochloride SPRAY, METERED;NASAL 209388 EVOKE PHARMA INC 01/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209388s001lbl.pdf#page=17
Gloperba Colchicine SOLUTION;ORAL 210942 ROMEG 02/11/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210942Orig1s001lbl.pdf#page=12
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 03/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s031lbl.pdf#page=32
Golytely Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous FOR SOLUTION;ORAL 019011 BRAINTREE 05/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019011s033lbl.pdf#page=9
Gralise Gabapentin TABLET;ORAL 022544 ALMATICA 09/16/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022544s026lbl.pdf#page=19
H.P. Acthar Gel Repository Corticotropin INJECTABLE; INJECTION 022432 QUESTCOR PHARMA 10/15/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf
Hadlima Adalimumab-Bwwd INJECTABLE;INJECTION 761059 SAMSUNG BIOEPIS CO LTD 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf#page=40
Halcion Triazolam TABLET;ORAL 017892 PFIZER 10/27/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017892s056lbl.pdf#page=20
Halflytely Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 021551 BRAINTREE 06/03/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM220644.pdf
Hemangeol Propranolol Hydrochloride SOLUTION;ORAL 205410 PIERRE FABRE DERMA 06/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf#page=11
Hemlibra Emicizumab INJECTABLE;INJECTION 761083 GENENTECH INC 12/16/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761083s013lbl.pdf#page=22
Horizant Gabapentin Enacarbil TABLET, EXTENDED RELEASE;ORAL 022399 ARBOR PHARMS LLC 04/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s010lbl.pdf#page=27
Hulio Adalimumab-Fkjp INJECTABLE;INJECTION 761154 MYLAN PHARMS INC 07/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf#page=41
Humira Adalimumab SYRINGE 125057 ABBVIE INC 02/24/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf#page=60
Humira Adalimumab VIAL 125057 ABBVIE INC 02/24/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf#page=60
Hycodan Homatropine METhylbromide; Hydrocodone Bitartrate TABLET;ORAL 005213 GENUS 09/27/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213s044lbl.pdf#page=27
Hycodan Homatropine METhylbromide; Hydrocodone Bitartrate SYRUP;ORAL 005213 GENUS 09/27/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213s044lbl.pdf#page=27
Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 PADAGIS US 03/04/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf
Hyrimoz Adalimumab-Adaz INJECTABLE;INJECTION 761071 SANDOZ INC 07/18/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761071s010s012lbl.pdf#page=41
Hysingla ER Hydrocodone Bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 PURDUE PHARMA LP 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206627s012lbl.pdf#page=39
Ibsrela Tenapanor Hydrochloride TABLET;ORAL 211801 ARDELYX INC 04/05/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.pdf#page=14
Iclusig Ponatinib Hydrochloride TABLET;ORAL 203469 TAKEDA PHARMS USA 02/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203469s035lbl.pdf#page=34
Idhifa Enasidenib Mesylate TABLET;ORAL 209606 CELGENE CORP 07/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf#page=17
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf#page=19
Ilumya Tildrakizumab-Asmn INJECTABLE;INJECTION 761067 SUN PHARMA GLOBAL 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf#page=10
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 07/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761069s028lbl.pdf#page=26
Imipramine Hydrochloride Imipramine Hydrochloride TABLET;ORAL 087846 SPECGX LLC 06/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf#page=3
Incivek Telaprevir TABLET;ORAL 201917 VERTEX PHARMS 03/25/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf
Indocin Indomethacin SUPPOSITORY;RECTAL 017814 EGALET 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017814s044lbl.pdf#page=24
Indocin Indomethacin CAPSULE;ORAL 016059 EGALET 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016059s101lbl.pdf#page=24
Indocin Indomethacin SUSPENSION;ORAL 018332 EGALET 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018332s042lbl.pdf#page=24
Indocin SR Indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185 EGALET 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018185s058lbl.pdf#page=25
Indomethacin Indomethacin CAPSULE;ORAL 018829 CHARTWELL MOLECULES 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018829s023lbl.pdf#page=18
Indomethacin Indomethacin CAPSULE;ORAL 018851 HERITAGE 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf#page=23
Indomethacin Indomethacin CAPSULE;ORAL 018858 RISING 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018858s047lbl.pdf#page=26
Inflectra Infliximab-Dyyb INJECTABLE;INJECTION 125544 CELLTRION INC 06/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125544s018lbl.pdf#page=61
Inrebic Fedratinib Hydrochloride CAPSULE;ORAL 212327 IMPACT 12/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212327s003lbl.pdf#page=20
Intermezzo Zolpidem Tartrate TABLET;SUBLINGUAL 022328 PURDUE PHARMA 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf#page=20
Intron A Interferon Alfa-2b VIAL 103132 SCHERING 11/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf#page=40
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 09/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021785s025lbl.pdf#page=25
Invirase Saquinavir Mesylate CAPSULE;ORAL 020628 HOFFMANN LA ROCHE 03/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020628s047,021785s023lbl.pdf#page=24
Invokamet Canagliflozin; METformin Hydrochloride TABLET;ORAL 204353 JANSSEN PHARMS 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/2020/204353s039,205879s017lbl.pdf#page=58
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/2020/206910s015lbl.pdf#page=31
Jadenu Sprinkle Deferasirox GRANULE;ORAL 207968 NOVARTIS 07/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207968s009lbl.pdf#page=31
Janumet Metformin Hydrochloride; Sitagliptin Phosphate TABLET;ORAL 022044 MERCK SHARP DOHME 06/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf#page=33
Janumet XR Metformin Hydrochloride; Sitagliptin Phosphate TABLET, EXTENDED RELEASE;ORAL 202270 MERCK SHARP DOHME 06/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf#page=34
Januvia Sitagliptin Phosphate TABLET;ORAL 021995 MERCK SHARP DOHME 06/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf#page=27
Jardiance Empagliflozin TABLET;ORAL 204629 BOEHRINGER INGELHEIM 03/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s034lbl.pdf#page=40
Jemperli Dostarlimab-Gxly INJECTABLE;INJECTION 761223 GLAXOSMITHKLINE LLC 08/17/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761223s000lbl.pdf#page=25
Jemperli Dostarlimab-Gxly INJECTABLE;INJECTION 761174 GLAXOSMITHKLINE 04/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf#page=25
Jentadueto Linagliptin; METformin Hydrochloride TABLET;ORAL 201281 BOEHRINGER INGELHEIM 04/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201281s031lbl.pdf#page=21
Jentadueto XR Linagliptin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 BOEHRINGER INGELHEIM 10/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208026s020lbl.pdf#page=21
Jeuveau Prabotulinumtoxina-Xvfs INJECTABLE;INJECTION 761085 EVOLUS INC 07/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761085s000lbl.pdf#page=9
Jornay PM Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311 IRONSHORE PHARMS 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209311s008lbl.pdf#page=19
Juvisync Simvastatin; Sitagliptin Phosphate TABLET;ORAL 202343 MERCK SHARP DOHME 02/24/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf
Juxtapid Lomitapide Mesylate CAPSULE;ORAL 203858 AMRYT 05/27/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf#page=32
Jynarque Tolvaptan TABLET;ORAL 204441 OTSUKA 11/25/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf#page=18
Kadian Morphine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616 ALLERGAN 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020616s065lbl.pdf#page=36
Kalbitor Ecallantide INJECTABLE; INJECTION 125277 DYAX CORP. 12/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125277s081lbl.pdf#page=13
Kaletra Lopinavir; Ritonavir TABLET;ORAL 021906 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53
Kaletra Lopinavir; Ritonavir SOLUTION;ORAL 021251 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021251s059,021906s054lbl.pdf#page=53
Kaletra Lopinavir; Ritonavir CAPSULE;ORAL 021226 ABBVIE 10/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021226s049lbl.pdf#page=53
Kazano Alogliptin Benzoate; METformin Hydrochloride TABLET;ORAL 203414 TAKEDA PHARMS USA 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf#page=32
Keppra Levetiracetam TABLET;ORAL 021035 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf#page=31
Keppra Levetiracetam SOLUTION;ORAL 021505 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021035s104,021505s044lbl.pdf#page=31
Keppra XR Levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285 UCB INC 09/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022285s029lbl.pdf#page=26
Kesimpta Ofatumumab SOLUTION;SUBCUTANEOUS 125326 NOVARTIS 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 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf#page=29
Kevzara Sarilumab INJECTABLE;INJECTION 761037 SANOFI SYNTHELABO 04/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf#page=27
Keytruda Pembrolizumab SOLUTION;INTRAVENOUS 125514 MERCK SHARP DOHME 05/20/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s123lbl.pdf#page=126
Khedezla Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204683 OSMOTICA PHARM CORP 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204683s007lbl.pdf#page=24
Klonopin Clonazepam TABLET;ORAL 017533 CHEPLAPHARM 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017533s061lbl.pdf#page=22
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/2019/202107s008lbl.pdf#page=20
Krystexxa Pegloticase INJECTABLE; INJECTION 125293 HORIZON PHARMA 07/07/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125293s104lbl.pdf#page=18
Kynamro Mipomersen Sodium SOLUTION;SUBCUTANEOUS 203568 KASTLE THERAPS LLC 03/18/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf
Lacosamide Lacosamide SOLUTION;ORAL 204839 AMNEAL PHARMS 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LacosamideTabletsCVMedGuide.pdf
Lacosamide Lacosamide TABLET;ORAL 204855 ACTAVIS LABS FL INC 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE TABLETSMedGuide.pdf
Lacosamide Lacosamide TABLET;ORAL 204857 AMNEAL PHARMS NY 08/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE ORAL SOLUTIONMed Guide.pdf
Lamictal Lamotrigine TABLET;ORAL 020241 GLAXOSMITHKLINE LLC 03/31/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65
Lamictal CD Lamotrigine TABLET, FOR SUSPENSION;ORAL 020764 GLAXOSMITHKLINE LLC 03/31/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65
Lamictal ODT Lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 GLAXOSMITHKLINE LLC 03/31/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115 GLAXOSMITHKLINE LLC 03/31/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022115s029lbl.pdf#page=51
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE; ORAL 022509 SMITHKLINE BEECHAM 01/29/2010 https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.pdf#page=39
Lamisil Terbinafine Hydrochloride GRANULE;ORAL 022071 NOVARTIS 03/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf#page=10
Lamisil Terbinafine Hydrochloride TABLET;ORAL 020539 NOVARTIS 03/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf#page=11
Lamivudine, Nevirapine and Zidovudine Lamivudine; Nevirapine; Zidovudine TABLET;ORAL 205626 MICRO LABS 08/13/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205626s000lbl.pdf#page=50
Lariam Mefloquine Hydrochloride TABLET;ORAL 019591 ROCHE 04/29/2011 https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf#page=13
Latuda Lurasidone Hydrochloride TABLET;ORAL 200603 SUNOVION PHARMS INC 12/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf#page=62
Lazanda Fentanyl Citrate SPRAY, METERED;NASAL 022569 BTCP PHARMA 12/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022569s030lbl.pdf#page=35
Lemtrada Alemtuzumab INJECTABLE;INJECTION 103948 GENZYME 05/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5185lbl.pdf#page=30
Letairis Ambrisentan TABLET;ORAL 022081 GILEAD 06/08/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022081s041lbl.pdf#page=26
Levaquin Levofloxacin SOLUTION;ORAL 021721 JANSSEN PHARMS 02/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf#page=59
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 02/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020634s073lbl.pdf#page=54
Levaquin Levofloxacin INJECTABLE;INJECTION 020635 JANSSEN PHARMS 02/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf#page=59
Levaquin Levofloxacin INJECTABLE;INJECTION 020635 JANSSEN PHARMS 02/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf#page=59
Lexapro Escitalopram Oxalate TABLET;ORAL 021323 ALLERGAN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf#page=21
Lexapro Escitalopram Oxalate SOLUTION;ORAL 021365 ALLERGAN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038,021323s053lbl.pdf#page=21
Librax Chlordiazepoxide Hydrochloride; Clidinium Bromide CAPSULE;ORAL 012750 BAUSCH 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012750s067lbl.pdf#page=11
Librium Chlordiazepoxide Hydrochloride CAPSULE;ORAL 012249 VALEANT PHARM INTL 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf#page=8
Libtayo Cemiplimab-Rwlc INJECTABLE;INTRAVENOUS 761097 REGENERON PHARMACEUTICALS 02/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s007lbl.pdf#page=29
Licart Diclofenac Epolamine SYSTEM;TOPICAL 206976 IBSA INST BIO 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206976s007lbl.pdf#page=21
Limbitrol Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 016949 HERITAGE PHARMS INC 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016949s041lbl.pdf#page=14
Limbitrol DS Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 016949 HERITAGE PHARMS INC 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016949s041lbl.pdf#page=14
Lindane Lindane SHAMPOO;TOPICAL 087266 OLTA PHARMS 04/05/2004 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneLotionMedGuide.pdf
Lindane Lindane LOTION;TOPICAL 087313 OLTA PHARMS 09/04/2001 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneShampooMedGuide.pdf
Linzess Linaclotide CAPSULE;ORAL 202811 ALLERGAN 08/24/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf#page=21
Lithium Carbonate Lithium Carbonate CAPSULE;ORAL 017812 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20
Lithium Carbonate Lithium Carbonate TABLET;ORAL 018558 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20
Lithium Citrate Lithium Citrate SYRUP;ORAL 018421 HIKMA 02/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017812s034,018421s033,018558s028lbl.pdf#page=20
Lotronex Alosetron Hydrochloride TABLET;ORAL 021107 SEBELA IRELAND LTD 04/03/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf
Lumoxiti Moxetumomab Pasudotox-Tdfk INJECTABLE;INJECTION 761104 INNATE PHARMA 08/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf#page=18
Lunesta Eszopiclone TABLET;ORAL 021476 SUNOVION PHARMS INC 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf#page=26
Lupkynis Voclosporin CAPSULE;ORAL 213716 AURINIA 01/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf#page=23
Lupron Leuprolide Acetate INJECTABLE;INJECTION 019010 ABBVIE ENDOCRINE INC 12/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf#page=27
Lupron Depot-Ped Kit Leuprolide Acetate POWDER;INTRAMUSCULAR 020263 ABBVIE ENDOCRINE INC 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020263s050lbl.pdf#page=23
Luvox Fluvoxamine Maleate TABLET;ORAL 021519 ANI PHARMS 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021519s018lbl.pdf#page=31
Luvox CR Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE;ORAL 022033 JAZZ PHARMS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf#page=26
Lybalvi Olanzapine; Samidorphan L-Malate TABLET;ORAL 213378 ALKERMES INC 05/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf#page=40
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA 01/31/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s021lbl.pdf#page=52
Lynparza Olaparib CAPSULE;ORAL 206162 ASTRAZENECA 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16
Lyrica Pregabalin SOLUTION;ORAL 022488 UPJOHN 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56
Lyrica Pregabalin CAPSULE;ORAL 021446 UPJOHN 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56
Lyrica CR Pregabalin TABLET, EXTENDED RELEASE;ORAL 209501 UPJOHN 04/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29
Magnevist Gadopentetate Dimeglumine INJECTABLE;INJECTION 021037 BAYER HLTHCARE 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13
Magnevist Gadopentetate Dimeglumine INJECTABLE;INJECTION 019596 BAYER HLTHCARE 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12
Marplan Isocarboxazid TABLET;ORAL 011961 VALIDUS PHARMS INC 11/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf#page=16
Mavenclad Cladribine TABLET;ORAL 022561 EMD SERONO INC 03/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022561s000lbl.pdf#page=29
Mayzent Siponimod Fumaric Acid TABLET;ORAL 209884 NOVARTIS 06/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209884Orig1s011lbl.pdf#page=23
Meridia Sibutramine Hydrochloride CAPSULE;ORAL 020632 ABBOTT 08/04/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf
Metadate CD Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259 LANNETT CO INC 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021259s025lbl.pdf#page=16
Methylin Methylphenidate Hydrochloride TABLET, CHEWABLE;ORAL 021475 SPECGX LLC 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021475s011lbl.pdf#page=13
Methylin Methylphenidate Hydrochloride SOLUTION;ORAL 021419 SPECGX LLC 07/19/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021419s010lbl.pdf#page=16
Metoclopramide Hydrochloride Metoclopramide Hydrochloride SOLUTION;ORAL 074703 WOCKHARDT BIO AG 04/08/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM244086.pdf
Metozolv ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246 SALIX PHARMS 02/28/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022246s009lbl.pdf#page=18
Mifeprex Mifepristone TABLET; ORAL 020687 DANCO LABS LLC 05/14/2021 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 SUSPENSION;ORAL 021530 AVONDALE PHARMS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021530s017lbl.pdf#page=16
Mobic Meloxicam TABLET;ORAL 020938 BOEHRINGER INGELHEIM 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf#page=16
Morphabond ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 206544 DAIICHI SANKYO INC 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf#page=38
Morphine Sulfate Morphine Sulfate TABLET;ORAL 022207 HIKMA 06/02/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf#page=26
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 022195 HIKMA 07/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf#page=29
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 201517 LANNETT CO INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf#page=29
Motrin Ibuprofen TABLET;ORAL 017463 MCNEIL CONSUMER 09/10/2007 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/2020/204760s009lbl.pdf#page=16
Moviprep Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 021881 SALIX PHARMS 05/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021881s023lbl.pdf#page=13
Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 205572 FRESENIUS KABI USA 07/26/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205572s007lbl.pdf#page=49
MS Contin Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 019516 PURDUE PHARMA LP 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019516s057lbl.pdf#page=29
Multaq Dronedarone Hydrochloride TABLET;ORAL 022425 SANOFI AVENTIS US 11/16/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=22
Multihance Gadobenate Dimeglumine INJECTABLE;INTRAVENOUS 021357 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34
Multihance Multipack Gadobenate Dimeglumine INJECTABLE;INTRAVENOUS 021358 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34
Myalept Metreleptin INJECTABLE;INJECTION 125390 AEGERION 02/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125390s024lbl.pdf#page=16
Mydayis Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 TAKEDA PHARMS USA 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf#page=22
Myfortic Mycophenolic Sodium TABLET, DELAYED RELEASE;ORAL 050791 NOVARTIS 03/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050791s035lbl.pdf#page=23
Myobloc Botulinum Toxin Type B VIAL 103846 ELAN PHARM 03/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf#page=17
Mysoline Primidone TABLET;ORAL 009170 VALEANT 06/10/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf#page=7
Nalfon Fenoprofen Calcium CAPSULE;ORAL 017604 XSPIRE PHARMA 04/28/2021 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf
Naprelan Naproxen Sodium TABLET, EXTENDED RELEASE;ORAL 020353 ALMATICA 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf#page=23
Naprosyn Naproxen TABLET;ORAL 017581 ATNAHS PHARMA US 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s064lbl.pdf#page=23
Naprosyn Naproxen SUSPENSION;ORAL 018965 ATNAHS PHARMA US 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018965s027lbl.pdf#page=23
Nardil Phenelzine Sulfate TABLET;ORAL 011909 PARKE DAVIS 08/02/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088660.pdf
Natpara Parathyroid Hormone INJECTABLE;INJECTION 125511 NPS PHARMS INC 07/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s016lbl.pdf#page=18
Nayzilam Midazolam SPRAY;NASAL 211321 UCB INC 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211321s005lbl.pdf#page=27
Nesina Alogliptin Benzoate TABLET;ORAL 022271 TAKEDA PHARMS USA 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf#page=29
Neurontin Gabapentin CAPSULE;ORAL 020235 UPJOHN 12/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf#Page=28
Neurontin Gabapentin TABLET;ORAL 020882 UPJOHN 12/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf#Page=28
Neurontin Gabapentin SOLUTION;ORAL 021129 UPJOHN 12/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf#Page=28
Nexium Esomeprazole Magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153 ASTRAZENECA 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf#page=41
Nexium Esomeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101 ASTRAZENECA 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf#page=41
Nexium Esomeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957 ASTRAZENECA 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059,021957s026,022101s023lbl.pdf#page=41
Nizoral Ketoconazole TABLET;ORAL 018533 JANSSEN PHARMS 02/25/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf
Nocdurna Desmopressin Acetate TABLET;SUBLINGUAL 022517 FERRING PHARMS INC 06/21/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022517s000lbl.pdf#page=14
Noctiva Desmopressin Acetate SPRAY, METERED;NASAL 201656 SERENITY PHARMS LLC 03/03/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf#page=13
Nolvadex Tamoxifen Citrate TABLET;ORAL 017970 ASTRAZENECA 03/13/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088661.pdf
Norco Acetaminophen; Hydrocodone Bitartrate TABLET;ORAL 040099 APIL 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/040099s023lbl.pdf#page=23
Noroxin Norfloxacin TABLET;ORAL 019384 MERCK 07/26/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf
Norpramin Desipramine Hydrochloride TABLET;ORAL 014399 VALIDUS PHARMS 11/09/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf
Novantrone Mitoxantrone Hydrochloride INJECTABLE;INJECTION 019297 EMD SERONO 03/23/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035mg.pdf
Nplate Romiplostim INJECTABLE; SUBCUTANEOUS 125268 AMGEN 02/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s167lbl.pdf#page=18
Nucynta Tapentadol Hydrochloride TABLET;ORAL 022304 COLLEGIUM PHARM INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022304s023lbl.pdf#page=33
Nucynta Tapentadol Hydrochloride SOLUTION;ORAL 203794 COLLEGIUM PHARM INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203794s009lbl.pdf#page=35
Nucynta ER Tapentadol Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 COLLEGIUM PHARM INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200533s023lbl.pdf#page=37
Nulojix Belatacept INJECTABLE; INJECTION 125288 BRISTOL MYERS SQUIBB 07/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49
Nulytely Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION;ORAL 019797 BRAINTREE 05/14/2021 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf
Nulytely-Flavored Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION;ORAL 019797 BRAINTREE 05/14/2021 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf
Nuvigil Armodafinil TABLET;ORAL 021875 CEPHALON 02/07/2017 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 05/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207999s007lbl.pdf#page=22
Ocrevus Ocrelizumab INJECTABLE;INJECTION 761053 GENENTECH INC 12/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf#page=18
Odomzo Sonidegib Phosphate CAPSULE;ORAL 205266 SUN PHARMA GLOBAL 05/13/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205266s006lbl.pdf#page=13
Oleptro Trazodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411 ANGELINI PHARMA 07/17/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf
Olumiant Baricitinib TABLET;ORAL 207924 ELI LILLY AND CO 05/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s006lbl.pdf#page=26
Omniscan Gadodiamide INJECTABLE;INJECTION 022066 GE HEALTHCARE 10/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1
Omniscan Gadodiamide INJECTABLE;INJECTION 020123 GE HEALTHCARE 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1
Omontys Peginesatide Acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799 TAKEDA PHARMS USA 12/04/2012 https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf#page=15
Onfi Clobazam SUSPENSION;ORAL 203993 LUNDBECK PHARMS LLC 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf#page=30
Onfi Clobazam TABLET;ORAL 202067 LUNDBECK PHARMS LLC 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202067s006,203993s008lbl.pdf#page=30
Onglyza Saxagliptin Hydrochloride TABLET;ORAL 022350 ASTRAZENECA AB 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf#page=31
Onsolis Fentanyl Citrate FILM;BUCCAL 022266 BDSI 12/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf#page=32
Opana Oxymorphone Hydrochloride TABLET;ORAL 021611 ENDO PHARMS 10/25/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf#page=27
Opana ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610 ENDO PHARMS 04/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021610s030lbl.pdf#page=31
Opana ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655 ENDO PHARMS 10/07/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf#page=26
Opdivo Nivolumab INJECTABLE;INJECTION 125554 BRISTOL MYERS SQUIBB 07/14/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s114lbl.pdf#page=134
Opsumit Macitentan TABLET;ORAL 204410 ACTELION 10/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204410s022lbl.pdf#page=20
Optimark Gadoversetamide INJECTABLE;INJECTION 020937 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=14
Optimark Gadoversetamide INJECTABLE;INJECTION 020975 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf#page=13
Optimark in Plastic Container Gadoversetamide INJECTABLE;INJECTION 020976 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf#page=13
Opzelura Ruxolitinib Phosphate CREAM;TOPICAL 215309 INCYTE CORP 07/18/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf#page=19
Oriahnn (Copackaged) Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium CAPSULE;ORAL 213388 ABBVIE INC 08/02/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213388s001lbl.pdf#page=29
Orilissa Elagolix Sodium TABLET;ORAL 210450 ABBVIE INC 02/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf#page=27
Oseni Alogliptin Benzoate; Pioglitazone Hydrochloride TABLET;ORAL 022426 TAKEDA PHARMS USA 07/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf#page=43
Osmoprep Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate TABLET;ORAL 021892 SALIX PHARMS 11/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf#page=13
Oxaydo Oxycodone Hydrochloride TABLET;ORAL 202080 ZYLA 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202080s012lbl.pdf#page=30
Oxtellar XR Oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810 SUPERNUS PHARMS 12/13/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 201194 VISTAPHARM 07/21/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf#page=33
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 200535 GENUS LIFESCIENCES 07/21/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf#page=67
Oxycontin Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272 PURDUE PHARMA LP 10/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s047lbl.pdf#page=48
Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046 ACTAVIS ELIZABETH 03/04/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf
Ozempic Semaglutide SOLUTION;SUBCUTANEOUS 209637 NOVO 03/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s009lbl.pdf#page=27
Pacerone Amiodarone Hydrochloride TABLET;ORAL 075135 UPSHER SMITH LABS 11/01/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf
Palladone Hydromorphone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044 PURDUE PHARMA LP 04/16/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf
Palynziq Pegvaliase-Pqpz INJECTABLE;INJECTION 761079 BIOMARIN PHARM 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf#page=23
Pamelor Nortriptyline Hydrochloride SOLUTION;ORAL 018012 SPECGX LLC 07/28/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf
Pamelor Nortriptyline Hydrochloride CAPSULE;ORAL 018013 SPECGX LLC 04/09/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf#page=15
Pancreaze Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022523 VIVUS INC 04/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf#page=16
Parnate Tranylcypromine Sulfate TABLET;ORAL 012342 CONCORDIA 01/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012342s064lbl.pdf#page=18
Paxil Paroxetine Hydrochloride TABLET;ORAL 020031 APOTEX TECHNOLOGIES 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf#page=39
Paxil Paroxetine Hydrochloride SUSPENSION;ORAL 020710 APOTEX TECHNOLOGIES 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020031s079,020710s047lbl.pdf#page=39
Paxil CR Paroxetine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936 APOTEX TECHNOLOGIES 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020936s060lbl.pdf#page=29
Peganone Ethotoin TABLET;ORAL 010841 RECORDATI RARE 02/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf
Pegasys Peginterferon Alfa-2a VIAL; SUBCUTANEOUS 103964 HOFFMAN-LA ROCHE 03/24/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39
Pegasys Peginterferon Alfa-2a SYRINGE 103964 HOFFMAN-LA ROCHE 03/24/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39
Pegintron Peginterferon Alfa-2b SYRINGE 103949 SCHERING 12/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29
Pennsaid Diclofenac Sodium SOLUTION;TOPICAL 020947 NUVO PHARMS INC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf
Pennsaid Diclofenac Sodium SOLUTION;TOPICAL 204623 HORIZON 06/07/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623Orig1s010lbl.pdf#page=20
Percocet Acetaminophen; Oxycodone Hydrochloride TABLET;ORAL 040330 VINTAGE PHARMS LLC 03/04/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/040330s052lbl.pdf
Percodan Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf#page=30
Percodan Aspirin; Oxycodone Hydrochloride TABLET;ORAL 007337 ENDO PHARMS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf#page=30
Perforomist Formoterol Fumarate SOLUTION;INHALATION 022007 MYLAN SPECLT 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf#page=19
Pertzye Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022175 DIGESTIVE CARE INC 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022175s006lbl.pdf#page=13
Pexeva Paroxetine Mesylate TABLET;ORAL 021299 SEBELA IRELAND LTD 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021299s037lbl.pdf#page=19
Phenergan VC W/ Codeine Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride SYRUP;ORAL 008306 ANI PHARMS 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29
Phenergan W/ Codeine Codeine Phosphate; Promethazine Hydrochloride SYRUP;ORAL 008306 ANI PHARMS 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29
Plavix Clopidogrel Bisulfate TABLET;ORAL 020839 SANOFI AVENTIS US 03/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020839s074lbl.pdf#page=24
Plegridy Peginterferon Beta-1a INJECTABLE;INJECTION 125499 BIOGEN IDEC INC 03/29/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125499s025lbl.pdf#page=20
Plenvu Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 209381 SALIX 05/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209381s002lbl.pdf#page=17
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 08/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf#page=33
Ponstel Mefenamic Acid CAPSULE;ORAL 015034 AVION PHARMS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/015034s045lbl.pdf#page=19
Ponvory Ponesimod TABLET;ORAL 213498 JANSSEN PHARMS 10/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213498s001lbl.pdf#page=30
Potiga Ezogabine TABLET;ORAL 022345 GLAXOSMITHKLINE 05/20/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf
Pradaxa Dabigatran Etexilate Mesylate CAPSULE;ORAL 022512 BOEHRINGER INGELHEIM 06/21/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022512s041lbl.pdf#page=27
Pradaxa Dabigatran Etexilate Mesylate PELLETS;ORAL 214358 BOEHRINGER INGELHEIM 03/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214358Orig1s001lbl.pdf#page=14
Prepopik Citric Acid; Magnesium Oxide; Sodium Picosulfate FOR SOLUTION;ORAL 202535 FERRING PHARMS INC 08/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202535s005lbl.pdf#page=15
Pretomanid Pretomanid TABLET;ORAL 212862 MYLAN IRELAND LTD 08/14/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212862s000lbl.pdf#page=19
Prevacid Lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406 TAKEDA PHARMS USA 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf#page=45
Prevacid Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 TAKEDA PHARMS USA 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020406s094,021428s041lbl.pdf#page=45
Prevacid Naprapac 250 (Copackaged) Lansoprazole; Naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507 TAKEDA PHARMS NA 07/31/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
Prevacid Naprapac 375 (Copackaged) Lansoprazole; Naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507 TAKEDA PHARMS NA 07/31/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
Prevacid Naprapac 500 (Copackaged) Lansoprazole; Naproxen CAPSULE, DELAYED REL PELLETS, TABLET;ORAL 021507 TAKEDA PHARMS NA 07/31/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088694.pdf
Priftin Rifapentine TABLET;ORAL 021024 SANOFI AVENTIS US 07/01/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021024s017s018lbl.pdf#page=28
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA 12/19/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf#page=34
Prilosec Omeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 COVIS 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022056s025lbl.pdf#page=34
Pristiq Desvenlafaxine Succinate TABLET, EXTENDED RELEASE;ORAL 021992 PF PRISM CV 11/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021992s047lbl.pdf#page=36
Probuphine Buprenorphine Hydrochloride IMPLANT;IMPLANTATION 204442 TITAN PHARMS 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204442s012lbl.pdf#page=48
Procrit Epoetin Alfa VIAL; SINGLE-USE 103234 AMGEN 07/25/2018 https://www.fda.gov/media/73511/download
Prohance Gadoteridol INJECTABLE;INJECTION 020131 BRACCO 12/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020131s035lbl.pdf#page16
Prohance Multipack Gadoteridol INJECTABLE;INJECTION 021489 BRACCO 05/06/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf#page=16
Prolia Denosumab INJECTABLE; SUBCUTANEOUS 125320 AMGEN 05/19/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125320s210lbl.pdf#page=31
Promacta Eltrombopag Olamine TABLET;ORAL 022291 NOVARTIS 03/31/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf#page=35
Promacta Kit Eltrombopag Olamine FOR SUSPENSION;ORAL 207027 NOVARTIS 03/31/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf#page=35
Propulsid Cisapride Monohydrate TABLET;ORAL 020210 JANSSEN PHARMS 03/06/2000 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Propulsid.pdf
Propylthiouracil Propylthiouracil TABLET;ORAL 006188 DAVA PHARMS INC 09/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf#page=7
Proquin XR Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744 DEPOMED INC 08/15/2011 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Proquin XR.pdf
Protonix Pantoprazole Sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020 WYETH PHARMS 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf#page=32
Protonix Pantoprazole Sodium TABLET, DELAYED RELEASE;ORAL 020987 WYETH PHARMS 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf#page=32
Protopic Tacrolimus OINTMENT;TOPICAL 050777 LEO PHARMA AS 02/25/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088996.pdf
Provigil Modafinil TABLET;ORAL 020717 CEPHALON 01/15/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020717s030s034s036MedGuide.pdf
Prozac Fluoxetine Hydrochloride CAPSULE;ORAL 018936 ELI LILLY AND CO 06/22/2009 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf#page=26
Prozac Weekly Fluoxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235 LILLY 03/24/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28
Qdolo Tramadol Hydrochloride SOLUTION;ORAL 214044 ATHENA 09/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214044s000lbl.pdf#page=27
Qelbree Viloxazine Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 211964 SUPERNUS PHARMS 04/29/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211964s003lbl.pdf#page=21
Qmiiz ODT Meloxicam TABLET, ORALLY DISINTEGRATING;ORAL 211210 TERSERA 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211210s002lbl.pdf#page=37
Qsymia Phentermine Hydrochloride; Topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580 VIVUS 06/24/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022580s021lbl.pdf#page=44
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s006lbl.pdf#page=37
Qternmet XR Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874 ASTRAZENECA AB 01/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210874s003lbl.pdf#page=47
Qualaquin Quinine Sulfate CAPSULE;ORAL 021799 SUN PHARM INDUSTRIES 06/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021799s029lbl.pdf#page=26
Qudexy XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 UPSHER SMITH LABS 02/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s012lbl.pdf#page=60
Quillichew ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NEXTWAVE PHARMS 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207960s012lbl.pdf#page=21
Quillivant XR Methylphenidate Hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100 NEXTWAVE 06/25/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202100s018lbl.pdf#page=21
Quviviq Daridorexant TABLET; ORAL 214985 IDORSIA PHARMACEUTICALS LTD. 01/07/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214985s000lbl.pdf#page=22
Rapamune Sirolimus SOLUTION;ORAL 021083 PF PRISM CV 01/02/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf#page=43
Rapamune Sirolimus TABLET;ORAL 021110 PF PRISM CV 08/09/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021110s086lbl.pdf#page=43
Ravicti Glycerol Phenylbutyrate LIQUID;ORAL 203284 HORIZON THERAP 09/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203284s012lbl.pdf#page=27
Rebetol Ribavirin CAPSULE;ORAL 020903 MERCK SHARP DOHME 03/16/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf#page=26
Rebetol Ribavirin SOLUTION;ORAL 021546 SCHERING 03/16/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf#page=26
Rebif Interferon Beta-1a SYRINGE 103780 SERONO INC 11/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103780s5210lbl.pdf#page=16
Reclast Zoledronic Acid INJECTABLE;INTRAVENOUS 021817 NOVARTIS 04/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021817s028lbl.pdf#page=25
Recorlev Levoketoconazole TABLET;ORAL 214133 STRONGBRIDGE 12/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214133s000lbl.pdf#page=24
Reglan Metoclopramide Hydrochloride TABLET;ORAL 017854 ANI PHARMS 08/29/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf
Reglan Metoclopramide Hydrochloride INJECTABLE;INJECTION 017862 HIKMA 11/18/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf
Reglan ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793 MEDA PHARMS 11/30/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf
Regranex Becaplermin GEL; TOPICAL 103691 SMITH AND NEPHEW 08/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf#page=8
Relistor Methylnaltrexone Bromide SOLUTION;SUBCUTANEOUS 021964 SALIX PHARMS 03/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf#page=24
Relistor Methylnaltrexone Bromide TABLET;ORAL 208271 SALIX 03/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf#page=24
Remeron Mirtazapine TABLET;ORAL 020415 ORGANON USA INC 11/18/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23
Remeron Soltab Mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 ORGANON USA INC 11/18/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23
Remicade Infliximab VIAL 103772 CENTOCOR INC 10/05/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf#page=50
Renflexis Infliximab-Abda INJECTABLE;INJECTION 761054 SAMSUNG BIOEPIS CO LTD 06/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf#page=52
Restoril Temazepam CAPSULE;ORAL 018163 SPECGX LLC 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018163s067lbl.pdf#page=16
Retacrit Epoetin Alfa-Epbx INJECTABLE;INJECTION 125545 HOSPIRA INC 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf#page=31
Revlimid Lenalidomide CAPSULE;ORAL 021880 CELGENE 05/24/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880s065lbl.pdf#page=48
Rexulti Brexpiprazole TABLET;ORAL 205422 OTSUKA 12/27/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205422s005lbl.pdf#page=27
Reyvow Lasmiditan Succinate TABLET;ORAL 211280 ELI LILLY AND CO 07/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211280s007lbl.pdf#page=15
Rezira Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride SOLUTION;ORAL 022442 PERSION 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf#page=26
Riabni Rituximab-Arrx INJECTABLE;INJECTION 761140 AMGEN INC 06/03/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761140s001lbl.pdf#page=41
Rinvoq Upadacitinib TABLET, EXTENDED RELEASE;ORAL 211675 ABBVIE INC 03/16/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211675s007lbl.pdf#page=56
Ritalin Methylphenidate Hydrochloride TABLET;ORAL 010187 NOVARTIS 06/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf#page=13
Ritalin LA Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NOVARTIS 06/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021284s043lbl.pdf#page=17
Ritalin-SR Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 018029 NOVARTIS 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf#page=13
Rituxan Rituximab SOLUTION;INTRAVENOUS 103705 GENENTECH 12/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf#page=56
Rituxan Hycela Rituximab; Hyaluronidase (Human Recombinant) SOLUTION;SUBCUTANEOUS 761064 GENENTECH INC 06/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761064s013lbl.pdf#page=28
Roxicodone Oxycodone Hydrochloride TABLET;ORAL 021011 SPECGX LLC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021011s011lbl.pdf#page=30
Roxybond Oxycodone Hydrochloride TABLET;ORAL 209777 OHEMO LIFE 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf#page=39
Rozerem Ramelteon TABLET;ORAL 021782 TAKEDA PHARMS USA 11/03/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021782s022lbl.pdf#page=17
Ruxience Rituximab-Pvvr INJECTABLE;INJECTION 761103 PFIZER INC 11/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf#page=42
Ruzurgi Amifampridine TABLET;ORAL 209321 JACOBUS PHARM CO INC 08/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf#page=15
Rybelsus Semaglutide TABLET;ORAL 213051 NOVO 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf#page=24
Rybelsus Semaglutide TABLET;ORAL 213182 NOVO NORDISK INC 01/16/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23
Sabril Vigabatrin FOR SOLUTION;ORAL 022006 LUNDBECK PHARMS LLC 10/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf#page=26
Sabril Vigabatrin TABLET;ORAL 020427 LUNDBECK PHARMS LLC 10/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf#page=26
Samsca Tolvaptan TABLET;ORAL 022275 OTSUKA 04/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022275s017lbl.pdf#page=19
Sarafem Fluoxetine Hydrochloride TABLET;ORAL 021860 APIL 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021860s015lbl.pdf#page=32
Savaysa Edoxaban Tosylate TABLET;ORAL 206316 DAIICHI SANKYO INC 11/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf#page=35
Savella Milnacipran Hydrochloride TABLET;ORAL 022256 ALLERGAN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022256s025lbl.pdf#page=31
Saxenda Liraglutide Recombinant SOLUTION;SUBCUTANEOUS 206321 NOVO 06/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206321s015lbl.pdf#page=30
Seglentis Celecoxib; Tramadol Hydrochloride TABLET;ORAL 213426 KOWA PHARMS 10/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213426s000lbl.pdf#page=56
Segluromet Ertugliflozin; METformin Hydrochloride TABLET;ORAL 209806 MERCK SHARP DOHME 03/02/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s008lbl.pdf#page=33
Selzentry Maraviroc SOLUTION;ORAL 208984 VIIV HLTHCARE 10/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43
Selzentry Maraviroc TABLET;ORAL 022128 VIIV HLTHCARE 10/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43
Serevent Salmeterol Xinafoate POWDER;INHALATION 020692 GLAXOSMITHKLINE 07/22/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf#page=35
Seroquel Quetiapine Fumarate TABLET;ORAL 020639 ASTRAZENECA 01/31/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020639s072lbl.pdf#page=49
Seroquel XR Quetiapine Fumarate TABLET, EXTENDED RELEASE;ORAL 022047 ASTRAZENECA 01/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022047s046lbl.pdf#page=53
Signifor Pasireotide Diaspartate SOLUTION;SUBCUTANEOUS 200677 RECORDATI RARE 01/15/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200677s006lbl.pdf#page=15
Signifor LAr Kit Pasireotide Pamoate FOR SUSPENSION;INTRAMUSCULAR 203255 RECORDATI RARE 07/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf#page=27
Siklos Hydroxyurea TABLET;ORAL 208843 ADDMEDICA SAS 12/07/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208843s003lbl.pdf#page=18
Silenor Doxepin Hydrochloride TABLET;ORAL 022036 CURRAX 10/29/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf#page=19
Siliq Brodalumab INJECTABLE;INJECTION 761032 VALEANT LUXEMBOURG 01/22/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf#page=13
Simponi Golimumab INJECTABLE; INJECTION 125289 CENTOCOR ORTHO BIOTECH INC 09/24/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf#page=38
Simponi Aria Golimumab INJECTABLE; INJECTION 125433 JANSSEN BIOTECH 02/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf#page=34
Sinequan Doxepin Hydrochloride CAPSULE;ORAL 016798 PFIZER 07/14/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089129.pdf
Singulair Montelukast Sodium TABLET;ORAL 020829 MSD MERCK CO 02/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s076,021409s052lbl.pdf#page=25
Singulair Montelukast Sodium TABLET, CHEWABLE;ORAL 020830 MSD MERCK CO 02/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25
Singulair Montelukast Sodium GRANULE;ORAL 021409 MERCK 02/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25
Sirturo Bedaquiline Fumarate TABLET;ORAL 204384 JANSSEN THERAP 12/09/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204384s016lbl.pdf#page=28
Skyrizi Risankizumab-Rzaa INJECTABLE;INJECTION 761105 ABBVIE INC 01/26/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf#page=19
Skyrizi Risankizumab-Rzaa INJECTABLE;SUBCUTANEOUS 761262 ABBVIE INC 06/16/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lbl.pdf#page=29
Sodium Oxybate Sodium Oxybate SOLUTION;ORAL 202090 HIKMA 01/03/2022 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18
Solaraze Diclofenac Sodium GEL;TOPICAL 021005 FOUGERA PHARMS 04/28/2021 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf
Solaraze Diclofenac Sodium GEL;TOPICAL 021005 FOUGERA PHARMS 04/05/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s023lbl.pdf#page=21
Soliqua 100/33 Insulin Glargine; Lixisenatide SOLUTION;SUBCUTANEOUS 208673 SANOFI-AVENTIS US 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf#page=29
Soliris Eculizumab INJECTABLE; IV (INFUSION) 125166 ALEXION PHARM 11/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf#page=40
Soltamox Tamoxifen Citrate SOLUTION;ORAL 021807 MAYNE PHARMA INC 04/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf#page=36
Sonata Zaleplon CAPSULE;ORAL 020859 PFIZER 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020859s016lbl.pdf#page=21
Soriatane Acitretin CAPSULE;ORAL 019821 STIEFEL LABS INC 09/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018mg.pdf
Sotret Isotretinoin CAPSULE;ORAL 076041 SUN PHARM INDS LTD 04/12/2012 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Sotret.pdf
Spravato Esketamine Hydrochloride SPRAY;NASAL 211243 JANSSEN PHARMS 01/03/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf#page=42
Spritam Levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 APRECIA PHARMS 01/19/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207958s019lbl.pdf#page=36
Sprix Ketorolac Tromethamine SPRAY, METERED;NASAL 022382 ZYLA 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022382s021lbl.pdf#page=22
Stavzor Valproic Acid CAPSULE, DELAYED RELEASE;ORAL 022152 BIONPHARMA INC 11/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022152s009lbl.pdf#page=42
Steglatro Ertugliflozin TABLET;ORAL 209803 MERCK SHARP DOHME 09/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf#page=25
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 06/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s011lbl.pdf#page=31
Stelara Ustekinumab INJECTABLE;INJECTION 761044 JANSSEN BIOTECH 07/29/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761044s010lbl.pdf#page=37
Stelara Ustekinumab INJECTABLE; INJECTION 125261 CENTOCOR ORTHO BIOTECH INC 07/29/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf#page=37
Strattera Atomoxetine Hydrochloride CAPSULE;ORAL 021411 LILLY 01/06/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021411s050lbl.pdf#page=20
Striverdi Respimat Olodaterol Hydrochloride SPRAY, METERED;INHALATION 203108 BOEHRINGER INGELHEIM 05/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/striverdi respimatMedGuide2016.pdf
Sublocade Buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 INDIVIOR INC 09/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf#page=45
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 020733 INDIVIOR INC 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020733s031s032lbl.pdf#page=32
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 INDIVIOR INC 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf#page=35
Subsys Fentanyl SPRAY;SUBLINGUAL 202788 BTCP PHARMA 12/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf#page=40
Subutex Buprenorphine Hydrochloride TABLET;SUBLINGUAL 020732 INDIVIOR INC 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.pdf#page=29
Suclear Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Potassium Sulfate; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate SOLUTION;ORAL 203595 BRAINTREE LABS 08/15/2013 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203595s000lbl.pdf#page=13
Sunosi Solriamfetol Hydrochloride TABLET;ORAL 211230 JAZZ 03/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230_Orig1Orig2s000lbl.pdf#page=23
Supprelin LA Histrelin Acetate IMPLANT;SUBCUTANEOUS 022058 ENDO PHARM 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022058s017lbl.pdf#page=20
Suprep Bowel Prep Kit Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate SOLUTION;ORAL 022372 BRAINTREE LABS 08/05/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022372s013lbl.pdf#page=13
Surmontil Trimipramine Maleate CAPSULE;ORAL 016792 ODYSSEY PHARMS 09/30/2014 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf#page=12
Sustol Granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445 HERON THERAPS INC 08/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524796.pdf
Sutab Magnesium Sulfate; Potassium Chloride; Sodium Sulfate TABLET;ORAL 213135 BRAINTREE LABS 02/01/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213135s003lbl.pdf#page=15
Sutent Sunitinib Malate CAPSULE;ORAL 021938 CPPI CV 08/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021938s039lbledt.pdf#page=34
Sylatron Peginterferon Alfa-2b VIAL 103949 SCHERING 12/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5312lbl.pdf#page=13
Symbyax Fluoxetine Hydrochloride; Olanzapine CAPSULE;ORAL 021520 LILLY 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021520s054lbl.pdf#page=42
Symlin Pramlintide Acetate INJECTABLE;SUBCUTANEOUS 021332 ASTRAZENECA AB 12/18/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf
Sympazan Clobazam FILM;ORAL 210833 AQUESTIVE 03/16/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210833s002lbl.pdf#page=27
Symproic Naldemedine Tosylate TABLET;ORAL 208854 BDSI 01/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf#page=13
Synalgos-DC Aspirin; Caffeine; Dihydrocodeine Bitartrate CAPSULE;ORAL 011483 SUN PHARM INDUSTRIES 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011483s034lbl.pdf#page=28
Synarel Nafarelin Acetate SPRAY, METERED;NASAL 019886 PFIZER 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019886s038lbl.pdf#page=28
Synjardy Empagliflozin; METformin Hydrochloride TABLET;ORAL 206111 BOEHRINGER INGELHEIM 03/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s031lbl.pdf#page=35
Synjardy XR Empagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658 BOEHRINGER INGELHEIM 03/21/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208658s017lbl.pdf#page=36
Synribo Omacetaxine Mepesuccinate POWDER;SUBCUTANEOUS 203585 TEVA PHARMS INTL 05/12/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203585Orig1s008lbl.pdf#page=18
Tafinlar Dabrafenib Mesylate CAPSULE;ORAL 202806 NOVARTIS 06/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s022lbl.pdf#page=40
Taltz Ixekizumab INJECTABLE;INJECTION 125521 ELI LILLY AND CO 07/27/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf#page=21
Tanzeum Albiglutide INJECTABLE;INJECTION 125431 GLAXOSMITHKLINE LLC 12/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf#page=36
Targiniq Naloxone Hydrochloride; Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777 PURDUE PHARMA LP 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf#page=47
Tasigna Nilotinib Hydrochloride CAPSULE;ORAL 022068 NOVARTIS 09/23/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf#page=36
Tavneos Avacopan CAPSULE;ORAL 214487 CHEMOCENTRYX 10/07/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214487s000lbl.pdf#page=17
Tazverik Tazemetostat Hydrobromide TABLET;ORAL 213400 EPIZYME INC 06/18/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213400s000lbl.pdf#page=17
Tazverik Tazemetostat Hydrobromide TABLET;ORAL 211723 EPIZYME INC 01/23/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211723s000lbl.pdf#page=14
Tecentriq Atezolizumab INJECTABLE;INJECTION 761034 GENENTECH INC 01/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s043lbl.pdf#page=61
Tecentriq Atezolizumab INJECTABLE; INJECTION 761041 GENENTECH INC 10/18/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041s000lbl.pdf#page=22
Technivie Ombitasvir; Paritaprevir; Ritonavir TABLET;ORAL 207931 ABBVIE INC 12/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207931s013lbl.pdf#page=39
Tegretol Carbamazepine SUSPENSION;ORAL 018927 NOVARTIS 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19
Tegretol Carbamazepine TABLET, CHEWABLE;ORAL 018281 NOVARTIS 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19
Tegretol Carbamazepine TABLET;ORAL 016608 NOVARTIS 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19
Tegretol-XR Carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234 NOVARTIS 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf#page=19
Tegsedi Inotersen Sodium SOLUTION;SUBCUTANEOUS 211172 AKCEA THERAPS 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211172s010lbl.pdf#page=28
Testim Testosterone GEL;TRANSDERMAL 021454 AUXILIUM PHARMS LLC 08/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021454s030s031lbl.pdf#page=21
Testosterone Testosterone GEL;TRANSDERMAL 202763 ANI PHARMS 10/25/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000mg.pdf
Testosterone Cypionate Injection Testosterone Cypionate INJECTABLE;INTRAMUSCULAR 216318 SLAYBACK PHARMA LLC 06/02/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216318s000lbl.pdf#page=14
Thalomid Thalidomide CAPSULE;ORAL 020785 CELGENE 08/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020785s068lbl.pdf#page=23
Tibsovo Ivosidenib TABLET;ORAL 211192 SERVIER 05/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf#page=34
Tikosyn Dofetilide CAPSULE;ORAL 020931 PFIZER 08/08/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020931s017lbl.pdf#page=27
Tivdak Tisotumab Vedotin-Tftv INJECTABLE;INJECTION 761208 SEAGEN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761208Orig1s000lbledt.pdf#page=21
Tivorbex Indomethacin CAPSULE;ORAL 204768 GENUS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204768s008lbl.pdf#page=25
Tofranil Imipramine Hydrochloride TABLET;ORAL 087846 SPECGX LLC 06/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf#page=3
Tofranil-Pm Imipramine Pamoate CAPSULE;ORAL 017090 SPECGX LLC 07/28/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326090.pdf
Tolectin Tolmetin Sodium TABLET;ORAL 017628 ORTHO MCNEIL JANSSEN 01/22/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf
Tolectin 600 Tolmetin Sodium TABLET;ORAL 017628 ORTHO MCNEIL JANSSEN 01/22/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf
Tolectin DS Tolmetin Sodium CAPSULE;ORAL 018084 ORTHO MCNEIL JANSSEN 01/22/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf
Topamax Topiramate CAPSULE;ORAL 020844 JANSSEN PHARMS 01/13/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf#page=54
Topamax Topiramate TABLET;ORAL 020505 JANSSEN PHARMS 01/13/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf#page=54
Topamax Sprinkle Topiramate CAPSULE;ORAL 020844 JANSSEN PHARMS 01/13/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020505s062,020844s053lbl.pdf#page=54
Toradol Ketorolac Tromethamine TABLET;ORAL 019645 ROCHE PALO 03/26/2013 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf#page=23
Tracleer Bosentan TABLET;ORAL 021290 ACTELION 05/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf#page=30
Tracleer Bosentan TABLET, FOR SUSPENSION;ORAL 209279 ACTELION 05/16/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021290s039,209279s005lbl.pdf#page=30
Tradjenta Linagliptin TABLET;ORAL 201280 BOEHRINGER INGELHEIM 04/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201280s025lbl.pdf#page=16
Transderm Scop Scopolamine SYSTEM;TRANSDERMAL 017874 BAXTER HLTHCARE CORP 03/01/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf#page=20
Tranxene Clorazepate Dipotassium CAPSULE;ORAL 017105 RECORDATI RARE 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017105s084lbl.pdf#page=13
Tranxene Clorazepate Dipotassium TABLET;ORAL 017105 RECORDATI RARE 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017105s084lbl.pdf#page=13
Tranxene SD Clorazepate Dipotassium TABLET;ORAL 017105 RECORDATI RARE 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017105s084lbl.pdf#page=13
Trazodone Hydrochloride Trazodone Hydrochloride TABLET;ORAL 071196 APOTEX INC 04/20/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf#page=3
Trelegy Ellipta Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate POWDER;INHALATION 209482 GLAXOSMITHKLINE 09/09/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf#page=33
Tremfya Guselkumab INJECTABLE;INJECTION 761061 JANSSEN BIOTECH 07/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf#page=15
Treximet Naproxen Sodium; Sumatriptan Succinate TABLET;ORAL 021926 CURRAX 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf#page=32
Tridione Trimethadione SOLUTION;ORAL 005856 ABBVIE 06/07/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf
Tridione Trimethadione CAPSULE;ORAL 005856 ABBVIE 06/07/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf
Tridione Trimethadione TABLET;ORAL 005856 ABBVIE 06/07/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf
Trijardy XR Empagliflozin; Linagliptin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614 BOEHRINGER INGELHEIM 06/11/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf#page=42
Trileptal Oxcarbazepine SUSPENSION;ORAL 021285 NOVARTIS 01/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26
Trileptal Oxcarbazepine TABLET;ORAL 021014 NOVARTIS 01/04/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26
Trintellix Vortioxetine Hydrobromide TABLET;ORAL 204447 TAKEDA PHARMS USA 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s024lbl.pdf#page=33
Triptodur Kit Triptorelin Pamoate FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 208956 ARBOR PHARMS LLC 04/22/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208956s010lbl.pdf#page=12
Triumeq Abacavir Sulfate; Dolutegravir Sodium; LAmivudine TABLET;ORAL 205551 VIIV HLTHCARE 03/30/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205551Orig1s028lbl.pdf#page=53
Triumeq Pd Abacavir Sulfate; Dolutegravir Sodium; LAmivudine SUSPENSION;ORAL 215413 VIIV HLTHCARE 03/30/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215413s000lbl.pdf#page=53
Trizivir Abacavir Sulfate; LAmivudine; Zidovudine TABLET;ORAL 021205 VIIV HLTHCARE 02/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf#page=34
Trokendi XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635 SUPERNUS PHARMS 02/03/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s029lbl.pdf#page=49
Troxyca ER Naltrexone Hydrochloride; Oxycodone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621 PFIZER 05/26/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf#page=32
Trudhesa Dihydroergotamine Mesylate SPRAY, METERED;NASAL 213436 IMPEL NEUROPHARMA 09/02/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213436s000lbl.pdf#page=22
Trulance Plecanatide TABLET;ORAL 208745 SALIX 04/13/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf#page=15
Trulicity Dulaglutide INJECTABLE;INJECTION 125469 ELI LILLY AND CO 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf#page=27
Truvada Emtricitabine; Tenofovir Disoproxil Fumarate TABLET;ORAL 021752 GILEAD 06/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf#page=35
Truxima Rituximab-Abbs INJECTABLE;INJECTION 761088 CELLTRION INC 02/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf#page=49
Turalio Pexidartinib Hydrochloride CAPSULE;ORAL 211810 DAIICHI SANKYO INC 07/14/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s010lbl.pdf#page=22
Tussionex Pennkinetic Chlorpheniramine Polistirex; Hydrocodone Polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111 UCB INC 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf#page=25
Tuxarin ER Chlorpheniramine Maleate; Codeine Phosphate TABLET, EXTENDED RELEASE;ORAL 206323 MAINPOINTE 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf#page=28
Tuzistra XR Chlorpheniramine Polistirex; Codeine Polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768 AYTU 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf#page=27
Tymlos Abaloparatide SOLUTION;SUBCUTANEOUS 208743 RADIUS HEALTH INC 12/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf#page=18
Tysabri Natalizumab VIAL; SINGLE-USE 125104 BIOGEN IDEC 12/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125104s973s975lbl.pdf#page=32
Tyzeka Telbivudine SOLUTION;ORAL 022154 NOVARTIS 12/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf#page=19
Tyzeka Telbivudine TABLET;ORAL 022011 NOVARTIS 12/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011s022,022154s019lbl.pdf#page=19
Ukoniq Umbralisib Tosylate TABLET;ORAL 213176 TG THERAPS 02/05/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213176s000lbl.pdf#page=19
Uloric Febuxostat TABLET;ORAL 021856 TAKEDA PHARMS USA 02/21/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021856s013lbl.pdf#page=19
Ultomiris Ravulizumab-Cwvz INJECTABLE;INJECTION 761108 ALEXION PHARM 04/27/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761108s023lbl.pdf#page=41
Ultracet Acetaminophen; Tramadol Hydrochloride TABLET;ORAL 021123 JANSSEN PHARMS 09/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021123s021lbl.pdf#page=46
Ultram Tramadol Hydrochloride TABLET;ORAL 020281 JANSSEN PHARMS 09/10/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020281s049lbl.pdf#page=43
Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692 VALEANT PHARMS 08/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf#page=36
Uplizna Inebilizumab-Cdon INJECTABLE;INJECTION 761142 VIELA BIO 06/11/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761142s000lbl.pdf#page=17
Valchlor Mechlorethamine Hydrochloride GEL;TOPICAL 202317 HELSINN 05/01/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s009lbl.pdf#page=10
Valium Diazepam TABLET;ORAL 013263 ROCHE 02/05/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf#page=14
Valtoco Diazepam SPRAY;NASAL 211635 NEURELIS INC 02/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211635s007lbl.pdf#page=22
Vantrela ER Hydrocodone Bitartrate TABLET, EXTENDED RELEASE;ORAL 207975 TEVA BRANDED PHARM 05/26/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207975s000lbl.pdf#page=39
Venbysi XR Venlafaxine Besylate TABLET, EXTENDED RELEASE; ORAL 215429 ALMATICA 06/29/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215429s000lbl.pdf#page=31
Venclexta Venetoclax TABLET;ORAL 208573 ABBVIE INC 10/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s026lbl.pdf#page=54
Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104 OSMOTICA PHARM 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022104s021lbl.pdf#page=35
Vibativ Telavancin Hydrochloride POWDER;INTRAVENOUS 022110 CUMBERLAND PHARMS 05/06/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf
Vibativ Telavancin INJECTABLE; INJECTION 022407 THERAVANCE INC 06/21/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf
Viberzi Eluxadoline TABLET;ORAL 206940 ALLERGAN HOLDINGS 06/17/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206940s007lbl.pdf#page=20
Vicoprofen Hydrocodone Bitartrate; Ibuprofen TABLET;ORAL 020716 ABBVIE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf#page=36
Victoza Liraglutide Recombinant SOLUTION;SUBCUTANEOUS 022341 NOVO NORDISK INC 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf#page=31
Victrelis Boceprevir CAPSULE;ORAL 202258 MERCK SHARP DOHME 01/30/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202258MG.pdf#page=27
Videx Didanosine FOR SOLUTION;ORAL 020156 BRISTOL-MYERS SQUIBB 12/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s054lbl.pdf#page=34
Videx EC Didanosine CAPSULE, DELAYED REL PELLETS;ORAL 021183 BRISTOL MYERS SQUIBB 12/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021183s029lbl.pdf#page=33
Viekira Pak (Copackaged) Dasabuvir Sodium; Ombitasvir, Paritaprevir, Ritonavir TABLET;ORAL 206619 ABBVIE INC 12/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206619s020lbl.pdf#page=49
Viekira XR Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir TABLET, EXTENDED RELEASE;ORAL 208624 ABBVIE INC 12/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208624s008lbl.pdf#page=49
Viibryd Vilazodone Hydrochloride TABLET;ORAL 022567 ALLERGAN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022567s022lbl.pdf#page=17
Vimovo Esomeprazole Magnesium; Naproxen TABLET, DELAYED RELEASE;ORAL 022511 HORIZON 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022511s028lbl.pdf#page=40
Vimpat Lacosamide TABLET;ORAL 022253 UCB INC 10/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s049,022254s039,022255s031lbl.pdf#page=31
Vimpat Lacosamide SOLUTION;INTRAVENOUS 022254 UCB INC 10/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s049,022254s039,022255s031lbl.pdf#page=31
Vimpat Lacosamide SOLUTION;ORAL 022255 UCB INC 10/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s049,022254s039,022255s031lbl.pdf#page=31
Viokace Pancrelipase (Amylase;Lipase;Protease) TABLET;ORAL 022542 VIOKACE 03/20/2020 http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf#page=12
Viramune Nevirapine SUSPENSION;ORAL 020933 BOEHRINGER INGELHEIM 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf#page=19
Viramune Nevirapine TABLET;ORAL 020636 BOEHRINGER INGELHEIM 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf#page=19
Viramune XR Nevirapine TABLET, EXTENDED RELEASE;ORAL 201152 BOEHRINGER INGELHEIM 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf#page=18
Visicol Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate TABLET;ORAL 021097 SALIX PHARMS 03/07/2013 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf#page=11
Vituz Chlorpheniramine Maleate; Hydrocodone Bitartrate SOLUTION;ORAL 204307 PERSION 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf#page=25
Vivactil Protriptyline Hydrochloride TABLET;ORAL 016012 TEVA WOMENS 07/17/2014 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Vivactil.pdf
Vivitrol Naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897 ALKERMES 05/06/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021897s052lbl.pdf#page=33
Vivlodex Meloxicam CAPSULE;ORAL 207233 ZYLA 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207233s004lbl.pdf#page=24
Vogelxo Testosterone GEL;TRANSDERMAL 204399 UPSHER SMITH LABS 04/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf#page=23
Vogelxo Testosterone GEL, METERED;TRANSDERMAL 204399 UPSHER SMITH LABS 04/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf#page=23
Voltaren Diclofenac Sodium TABLET, DELAYED RELEASE;ORAL 019201 NOVARTIS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019201s048lbl.pdf#page=18
Voltaren Arthritis Pain Diclofenac Sodium GEL;TOPICAL 022122 GLAXOSMITHKLINE CONS 11/03/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf#page=22
Voltaren-XR Diclofenac Sodium TABLET, EXTENDED RELEASE;ORAL 020254 NOVARTIS 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf#page=18
Votrient Pazopanib Hydrochloride TABLET;ORAL 022465 NOVARTIS 09/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf#page=27
Vraylar Cariprazine Hydrochloride CAPSULE;ORAL 204370 ALLERGAN 05/24/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf#page=39
Vyvanse Lisdexamfetamine Dimesylate TABLET, CHEWABLE;ORAL 208510 TAKEDA PHARMS USA 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38
Vyvanse Lisdexamfetamine Dimesylate CAPSULE;ORAL 021977 TAKEDA PHARMS USA 02/25/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38
Wegovy Semaglutide SOLUTION;SUBCUTANEOUS 215256 NOVO 06/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf#page=26
Welireg Belzutifan TABLET;ORAL 215383 MERCK SHARP DOHME 08/13/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf#page=14
Wellbutrin Bupropion Hydrochloride TABLET;ORAL 018644 GLAXOSMITHKLINE 10/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018644s057lbl.pdf#page=32
Wellbutrin SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358 GLAXOSMITHKLINE 10/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020358s064lbl.pdf#page=34
Wellbutrin XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515 BAUSCH 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021515s044lbl.pdf#page=29
Xalkori Crizotinib CAPSULE;ORAL 202570 PF PRISM CV 09/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s031lbl.pdf#page=35
Xanax Alprazolam TABLET;ORAL 018276 UPJOHN 03/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018276s058lbl.pdf#page=27
Xanax XR Alprazolam TABLET, EXTENDED RELEASE;ORAL 021434 UPJOHN 03/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021434s021lbl.pdf#page=26
Xarelto Rivaroxaban TABLET;ORAL 022406 JANSSEN PHARMS 03/01/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77
Xarelto Rivaroxaban TABLET;ORAL 202439 JANSSEN PHARMS 03/01/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77
Xarelto Rivaroxaban FOR SUSPENSION;ORAL 215859 JANSSEN PHARMS 12/20/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf#page=77
Xartemis XR Acetaminophen; Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031 MALLINCKRODT INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf#page=34
Xcopri Cenobamate TABLET;ORAL 212839 SK LIFE 06/27/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212839s006s007lbl.pdf#page=25
Xeljanz Tofacitinib Citrate SOLUTION;ORAL 213082 PFIZER 12/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66
Xeljanz Tofacitinib Citrate TABLET;ORAL 203214 PF PRISM CV 12/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66
Xeljanz XR Tofacitinib Citrate TABLET, EXTENDED RELEASE;ORAL 208246 PFIZER 12/14/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66
Xenazine Tetrabenazine TABLET;ORAL 021894 BAUSCH 09/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf#page=24
Xeomin Incobotulinumtoxina INJECTABLE;INJECTION 125360 MERZ PHARMS 08/13/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s093lbl.pdf#page=23
Xiaflex Collagenase Clostridium Histolyticum SOLUTION; INJECTION 125338 AUXILIUM PHARMS 01/11/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s117lbl.pdf#page=33
Xigduo XR Dapagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649 ASTRAZENECA AB 04/11/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s017lbl.pdf#page=59
Xolair Omalizumab VIAL 103976 GENENTECH 04/09/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf#page=36
Xospata Gilteritinib Fumarate TABLET;ORAL 211349 ASTELLAS 01/12/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf#page=18
Xpovio Selinexor TABLET;ORAL 212306 KARYOPHARM THERAPS 03/28/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s010lbl.pdf#page=31
Xtampza ER Oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 COLLEGIUM PHARM INC 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208090s015lbl.pdf#page=39
Xultophy 100/3.6 Insulin Degludec; Liraglutide SOLUTION;SUBCUTANEOUS 208583 NOVO 06/10/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf#page=40
Xyosted (Autoinjector) Testosterone Enanthate SOLUTION;SUBCUTANEOUS 209863 ANTARES PHARMA INC 11/19/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf#page=16
Xyrem Sodium Oxybate SOLUTION;ORAL 021196 JAZZ PHARMS 12/09/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s032lbl.pdf#page=26
Xywav Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate SOLUTION;ORAL 212690 JAZZ 12/09/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s036,212690s001s006lbl.pdf#page=29
Yervoy Ipilimumab INJECTABLE; INJECTION 125377 BRISTOL MYERS SQUIBB 05/27/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s122lbl.pdf#page=72
Yondelis Trabectedin POWDER;INTRAVENOUS 207953 JANSSEN PRODS 06/03/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf#page=20
Yosprala Aspirin; Omeprazole TABLET, DELAYED RELEASE;ORAL 205103 GENUS LIFESCIENCES 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205103s008lbl.pdf#page=29
Yusimry Adalimumab-Aqvh INJECTABLE;INJECTION 761216 COHERUS BIOSCIENCES INC 12/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761216s000lbl.pdf#page=38
Zarontin Ethosuximide CAPSULE;ORAL 012380 PARKE DAVIS 10/28/2021 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034mg.pdf
Zegerid Omeprazole; Sodium Bicarbonate CAPSULE;ORAL 021849 SALIX 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf#page=31
Zegerid Omeprazole; Sodium Bicarbonate FOR SUSPENSION;ORAL 021636 SALIX 03/04/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf#page=31
Zelboraf Vemurafenib TABLET;ORAL 202429 HOFFMANN LA ROCHE 05/18/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf#page=21
Zenpep Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022210 ZENPEP 03/20/2020 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf
Zeposia Ozanimod Hydrochloride CAPSULE;ORAL 209899 CELGENE INTL 12/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209899s003lbl.pdf#page=25
Zerit Stavudine FOR SOLUTION;ORAL 020413 BRISTOL-MYERS SQUIBB 12/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020412s041,020413s033lbl.pdf#page=29
Ziagen Abacavir Sulfate SOLUTION;ORAL 020978 VIIV HLTHCARE 11/24/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020977s035,020978s038lbl.pdf#page=27
Zinbryta Daclizumab INJECTABLE;INJECTION 761029 BIOGEN 11/01/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf#page=24
Zipsor Diclofenac Potassium CAPSULE;ORAL 022202 ASSERTIO 05/25/2021 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243355.pdf
Zohydro ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880 RECRO GAINESVILLE 03/04/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202880s020lbl.pdf#page=30
Zoloft Sertraline Hydrochloride CONCENTRATE;ORAL 020990 UPJOHN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf#page=27
Zoloft Sertraline Hydrochloride TABLET;ORAL 019839 UPJOHN 09/20/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf#page=27
Zolpidem Tartrate Zolpidem Tartrate TABLET;ORAL 076062 STRIDES PHARMA 04/23/2007 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Zolpidem.pdf
Zolpimist Zolpidem Tartrate SPRAY, METERED;ORAL 022196 AYTU 08/18/2019 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s012lbl.pdf#page=19
Zonegran Zonisamide CAPSULE;ORAL 020789 CONCORDIA 04/13/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf#page=25
Zonisade Zonisamide SUSPENSION;ORAL 214273 AZURITY 07/15/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214273s000lbl.pdf#page=27
Zontivity Vorapaxar Sulfate TABLET;ORAL 204886 XSPIRE PHARMA 11/07/2019 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf
Zortress Everolimus TABLET;ORAL 021560 NOVARTIS 08/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf#page=32
Zorvolex Diclofenac CAPSULE;ORAL 204592 ZYLA 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204592s013lbl.pdf#page=26
Zubsolv Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 204242 OREXO US INC 06/17/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf#page=20
Zulresso Brexanolone SOLUTION;INTRAVENOUS 211371 SAGE THERAP 06/16/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211371s007lbl.pdf#page=20
Zurampic Lesinurad TABLET;ORAL 207988 IRONWOOD PHARMS INC 08/04/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf#page=17
Zutripro Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride SOLUTION;ORAL 022439 PERSION 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022439s010lbl.pdf#page=28
Zyban Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711 GLAXOSMITHKLINE 03/09/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020711s052lbl.pdf#page=38
Zydelig Idelalisib TABLET;ORAL 205858 GILEAD SCIENCES INC 02/18/2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205858s016lbl.pdf#page=25
Zyprexa Olanzapine TABLET;ORAL 020592 LILLY 04/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf#page=37
Zyprexa Olanzapine INJECTABLE;INTRAMUSCULAR 021253 LILLY 04/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf#page=37
Zyprexa Relprevv Olanzapine Pamoate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022173 ELI LILLY CO 04/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022173s036lbl.pdf#page=29
Zyprexa Zydis Olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086 LILLY 04/23/2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s075,021086s049,021253s062lbl.pdf#page=37
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