Medication Guides

Medication Guides (MGs) are a type of labeling for patients and caregivers that are required by the FDA when:
The MG could help prevent serious side effects,
The medicine has serious side effects (relative to benefits) in which patients should be made aware of, or
Following directions for the use of the medicine is important for the medicine's effectiveness.
This database contains MGs for FDA-approved human prescription drugs and therapeutic biological products. Although this database does not include MGs for vaccines, allergenic products, blood products, plasma derivatives, and cellular and gene therapy products, such MGs can be found on FDALabel or DailyMed. For more information about MGs see "What are Medication Guides" on the Patient Labeling Resources webpage.
This database contains MGs for FDA-approved human prescription drugs and therapeutic biological products. Although this database does not include MGs for vaccines, allergenic products, blood products, plasma derivatives, and cellular and gene therapy products, such MGs can be found on FDALabel or DailyMed. For more information about MGs see "What are Medication Guides" on the Patient Labeling Resources webpage.
To find a MG, start typing the name of the drug or the active ingredient(s) in the drug in the "Search" box. Click on the drug name to view the MG in PDF format.
Click on drug name to view Medication Guide in PDF format.
Drug Name | Active Ingredient | Form;Route | Appl. No. | Company | Date | Link |
---|---|---|---|---|---|---|
Drug Name | Active Ingredient | Form;Route | Appl. No. | Company | Date | Link |
Abilify | Aripiprazole | TABLET;ORAL | 021436 | OTSUKA | 11/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021436s048lbl.pdf#page=47 |
Abilify | Aripiprazole | SOLUTION;ORAL | 021713 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
Abilify | Aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
Abilify | Aripiprazole | INJECTABLE;INTRAMUSCULAR | 021866 | OTSUKA | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021436s044s045,021713s035s036,021729s027s028,021866s029s030lbl.pdf#page=77 |
Abilify Maintena Kit | Aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971 | OTSUKA PHARM CO LTD | 02/05/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202971s013lbl.pdf#page=52 |
Abilify Mycite Kit | Aripiprazole | TABLET;ORAL | 207202 | OTSUKA | 11/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207202s006lbl.pdf#page=64 |
Abrilada | Adalimumab-Afzb | INJECTABLE;INJECTION | 761118 | PFIZER INC | 08/16/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s011lbl.pdf#page=53 |
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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020973s043lbl.pdf#page=34 |
Aciphex Sprinkle | Rabeprazole Sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736 | AYTU | 11/27/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf#page=21 |
Actemra | Tocilizumab | INJECTABLE; INJECTION | 125276 | GENENTECH | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125276s134lbl.pdf#page=50 |
Actemra | Tocilizumab | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 125472 | GENENTECH | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s046lbl.pdf#page=50 |
Acthar Gel | Corticotropin | INJECTABLE;INJECTION | 008372 | MALLINCKRODT ARD | 10/29/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s071lbl.pdf#page=17 |
Actiq | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 020747 | CEPHALON | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020747s056lbl.pdf#page=43 |
Actonel | Risedronate Sodium | TABLET;ORAL | 020835 | APIL | 11/05/2019 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020835s052lbl.pdf#page=38 |
Actonel With Calcium (Copackaged) | Calcium Carbonate; Risedronate Sodium | TABLET;ORAL | 021823 | WARNER CHILCOTT | 04/08/2015 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf#page=27 |
Actoplus MET | Metformin Hydrochloride; Pioglitazone Hydrochloride | TABLET;ORAL | 021842 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf#page=41 |
Actoplus MET XR | Metformin Hydrochloride; Pioglitazone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022024 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022024s014lbl.pdf#page=41 |
Actos | Pioglitazone Hydrochloride | TABLET;ORAL | 021073 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35 |
Adasuve | Loxapine | POWDER;INHALATION | 022549 | ALEXZA PHARMS | 02/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf#page=28 |
Adderall 10 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 12.5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 15 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 20 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 30 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall 7.5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | TABLET;ORAL | 011522 | TEVA WOMENS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011522s044lbl.pdf#page=15 |
Adderall XR 10 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021303s036lbl.pdf#page=23 |
Adderall XR 15 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
Adderall XR 20 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
Adderall XR 25 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
Adderall XR 30 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
Adderall XR 5 | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303 | TAKEDA PHARMS USA | 07/03/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021303s034lbl.pdf#page=24 |
Addyi | Flibanserin | TABLET;ORAL | 022526 | SPROUT PHARMS | 04/11/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf#page=23 |
Adempas | Riociguat | TABLET;ORAL | 204819 | BAYER HLTHCARE | 09/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204819s015lbl.pdf#page=24 |
Adhansia XR | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212038 | PURDUE PHARMA LP | 06/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf#page=25 |
Adlyxin | Lixisenatide | SOLUTION;SUBCUTANEOUS | 208471 | SANOFI-AVENTIS US | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf#page=24 |
Adzenys ER | Amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 204325 | NEOS THERAPS INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204325s003lbl.pdf#page=26 |
Adzenys XR-Odt | Amphetamine | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 204326 | NEOS THERAPS | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf#page=26 |
Afrezza | Insulin Recombinant Human | POWDER;INHALATION | 022472 | MANNKIND | 02/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022472s023lbl.pdf#page=19 |
Alkindi Sprinkle | Hydrocortisone | GRANULE;ORAL | 213876 | ETON | 12/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213876s002lbl.pdf#page=14 |
Ambien | Zolpidem Tartrate | TABLET;ORAL | 019908 | SANOFI AVENTIS US | 02/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf#page=24 |
Ambien CR | Zolpidem Tartrate | TABLET, EXTENDED RELEASE;ORAL | 021774 | SANOFI AVENTIS US | 02/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021774s021s025s028lbl.pdf#page=27 |
Amjevita | Adalimumab-Atto | INJECTABLE;INJECTION | 761024 | AMGEN INC | 08/14/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761024s015lbl.pdf#page=50 |
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 |
Aptryxol | Desvenlafaxine | TABLET,EXTENDED RELEASE;ORAL | 205583 | SUN PHARMACEUTICAL | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205583s014lbl.pdf#page=30 |
Aranesp | Darbepoetin Alfa | VIAL; INTRAVENOUS | 103951 | AMGEN | 01/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25 |
Aranesp | Darbepoetin Alfa | VIAL; SUBCUTANEOUS | 103951 | AMGEN | 01/30/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103951s5377lbl.pdf#page=25 |
Arcapta Neohaler | Indacaterol Maleate | POWDER;INHALATION | 022383 | NOVARTIS | 07/30/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf |
Arikayce Kit | Amikacin Sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356 | INSMED INC | 10/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356s004lbl.pdf#page=15 |
Aristada | Aripiprazole LAuroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207533 | ALKERMES INC | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=36 |
Aristada Initio Kit | Aripiprazole LAuroxil | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 209830 | ALKERMES INC | 03/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf#page=72 |
Arthrotec | Diclofenac Sodium; Misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607 | PFIZER | 08/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020607s040lbl.pdf#page33 |
Arymo ER | Morphine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 208603 | ZYLA | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf#page=34 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 204096 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf#page=91 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 050709 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf#page=91 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 050708 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050708s054,050709s047,204096s010lbl.pdf#page=91 |
Astagraf XL | Tacrolimus | CAPSULE, EXTENDED RELEASE;ORAL | 210115 | ASTELLAS | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210115s006lbl.pdf#page=33 |
Atelvia | Risedronate Sodium | TABLET, DELAYED RELEASE;ORAL | 022560 | APIL | 08/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022560s011lbl.pdf#page=24 |
Ativan | Lorazepam | TABLET;ORAL | 017794 | BAUSCH | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017794s049lbl.pdf#page=14 |
Aubagio | Teriflunomide | TABLET;ORAL | 202992 | SANOFI AVENTIS US | 04/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf#page=25 |
Austedo | Deutetrabenazine | TABLET;ORAL | 208082 | TEVA BRANDED PHARM | 05/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208082s011lbl.pdf#page=25 |
Austedo | Deutetrabenazine | TABLET;ORAL | 216354 | TEVA NEUROSCIENCE | 02/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216354s000lbl.pdf#page=29 |
Auvelity | Bupropion; Dextromethorphan | TABLET, EXTENDED RELEASE; ORAL | 215430 | AXSOME INC | 08/18/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215430s000lblCorrect3.pdf#page=25 |
Avandamet | Metformin Hydrochloride; Rosiglitazone Maleate | TABLET;ORAL | 021410 | SB PHARMCO | 04/05/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf#page=38 |
Avandaryl | Glimepiride; Rosiglitazone Maleate | TABLET;ORAL | 021700 | SB PHARMCO | 04/27/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217006s000lbl.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 | 07/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103628s5269lbl.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 | 02/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf#page=41 |
Benlysta | Belimumab | INJECTABLE; INJECTION | 125370 | HUMAN GENOME SCIENCES INC. | 02/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.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 | 07/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103471s5202lbl.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 | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf#page=41 |
Boniva | Ibandronate Sodium | INJECTABLE;INTRAVENOUS | 021858 | ROCHE | 01/11/2022 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18 |
Boniva | Ibandronate Sodium | TABLET;ORAL | 021455 | HOFFMANN LA ROCHE | 12/07/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf#page=19 |
Bonsity | Teriparatide | SOLUTION;SUBCUTANEOUS | 211939 | ALVOGEN | 10/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211939s000lbl.pdf#page=25 |
Botox | Onabotulinumtoxina | VIAL; SINGLE-USE | 103000 | ALLERGAN | 08/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000s5327lbl.pdf#page=49 |
Botox Cosmetic | Onabotulinumtoxina | VIAL; SINGLE-USE | 103000 | ALLERGAN | 08/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103000s5327lbl.pdf#page=49 |
Braftovi | Encorafenib | CAPSULE;ORAL | 210496 | ARRAY BIOPHARMA INC | 02/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210496s013lbl.pdf#page=22 |
Brenzavvy | Bexagliflozin | TABLET;ORAL | 214373 | THERACOS BIO | 01/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214373s000lbl.pdf#page=23 |
Brexafemme | Ibrexafungerp | TABLET;ORAL | 214900 | SCYNEXIS | 11/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214900s002lbl.pdf#page=18 |
Brilinta | Ticagrelor | TABLET;ORAL | 022433 | ASTRAZENECA | 05/09/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022433s034lbl.pdf#page=35 |
Brisdelle | Paroxetine Mesylate | CAPSULE;ORAL | 204516 | SEBELA IRELAND LTD | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204516s013lbl.pdf#page=18 |
Briumvi | Ublituximab-Xiiy | INJECTABLE;INJECTION | 761238 | TG Therapeutics | 12/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf#page=18 |
Briviact | Brivaracetam | TABLET;ORAL | 205836 | UCB INC | 05/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205836s014,205837s011,205838s011lbl.pdf#page=18 |
Briviact | Brivaracetam | SOLUTION;INTRAVENOUS | 205837 | UCB INC | 05/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205836s014,205837s011,205838s011lbl.pdf#page=18 |
Briviact | Brivaracetam | SOLUTION;ORAL | 205838 | UCB INC | 05/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205836s014,205837s011,205838s011lbl.pdf#page=18 |
Brixadi | Buprenorphine | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136 | BRAEBURN | 05/23/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136s000lbl.pdf#page=52 |
Brovana | Arformoterol Tartrate | SOLUTION;INHALATION | 021912 | SUNOVION | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf#page=22 |
Bunavail | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;BUCCAL | 205637 | BDSI | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf#page=33 |
Butrans | Buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306 | PURDUE PHARMA LP | 06/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021306s039lbl.pdf#page=43 |
Bydureon | Exenatide Synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf#page=37 |
Bydureon Bcise | Exenatide Synthetic | SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 209210 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209210s022lbl.pdf#page=36 |
Bydureon Pen | Exenatide Synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf#page=37 |
Byetta | Exenatide Synthetic | INJECTABLE; SUBCUTANEOUS | 021919 | AMYLIN | 10/30/2009 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf |
Byetta | Exenatide Synthetic | INJECTABLE;SUBCUTANEOUS | 021773 | ASTRAZENECA AB | 12/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf#page=33 |
Cambia | Diclofenac Potassium | FOR SOLUTION;ORAL | 022165 | ASSERTIO | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf#page=23 |
Camzyos | Mavacamten | CAPSULE;ORAL | 214998 | BRISTOL MYERS SQUIBB | 06/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214998s001lbl.pdf#page=29 |
Caplyta | Lumateperone Tosylate | CAPSULE;ORAL | 209500 | INTRA-CELLULAR | 06/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209500s011lbl.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 | 04/11/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020712s038lbl.pdf#page=23 |
Cassipa | Buprenorphine Hydrochloride; Naloxone Hydrochloride | FILM;SUBLINGUAL | 208042 | TEVA PHARMS USA | 03/23/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208042s009lbl.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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020822s054lbl.pdf#page=22 |
Cellcept | Mycophenolate Mofetil | CAPSULE;ORAL | 050722 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Cellcept | Mycophenolate Mofetil | TABLET;ORAL | 050723 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Cellcept | Mycophenolate Mofetil Hydrochloride | INJECTABLE;INJECTION | 050758 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Cellcept | Mycophenolate Mofetil | FOR SUSPENSION;ORAL | 050759 | ROCHE PALO | 08/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050722s050,050723s050,050758s048,050759s055lbl.pdf#page=39 |
Celontin | Methsuximide | CAPSULE;ORAL | 010596 | PARKE DAVIS | 06/15/2011 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf |
Cerdelga | Eliglustat Tartrate | CAPSULE;ORAL | 205494 | GENZYME CORP | 08/29/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf#page=19 |
Chantix | Varenicline Tartrate | TABLET;ORAL | 021928 | PF PRISM CV | 02/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021928s048lbl.pdf#page=22 |
Chlordiazepoxide and Amitriptyline Hydrochloride | Amitriptyline Hydrochloride; Chlordiazepoxide | TABLET;ORAL | 071297 | MYLAN PHARMS INC | 02/05/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf |
Cibinqo | Abrocitinib | TABLET; ORAL | 213871 | PFIZER INC | 01/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213871s000lbl.pdf#page=26 |
Cimzia | Certolizumab Pegol | INJECTABLE; INJECTION | 125160 | UCB INC | 12/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125160s305lbl.pdf#page=40 |
Cipro | Ciprofloxacin | INJECTABLE;INJECTION | 019847 | BAYER HLTHCARE | 03/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019847s063lbl.pdf#page=33 |
Cipro | Ciprofloxacin Hydrochloride | TABLET;ORAL | 019537 | BAYER HLTHCARE | 07/26/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s092lbl.pdf#page=39 |
Cipro | Ciprofloxacin | FOR SUSPENSION;ORAL | 020780 | BAYER HLTHCARE | 07/26/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s093,020780s049lbl.pdf#page=40 |
Cipro in Dextrose 5% in Plastic Container | Ciprofloxacin | INJECTABLE;INJECTION | 019857 | BAYER HLTHCARE | 03/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019857s073lbl.pdf#page=33 |
Cipro XR | Ciprofloxacin; Ciprofloxacin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021473 | BAYER HLTHCARE | 07/26/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021473s043lbl.pdf#page=30 |
Citalopram | Citalopram Hydrobromide | CAPSULE; ORAL | 215428 | ALMATICA | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215428s002lbl.pdf#page=24 |
Clenpiq | Citric Acid; Magnesium Oxide; Sodium Picosulfate | SOLUTION;ORAL | 209589 | FERRING PHARMS INC | 08/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209589s014lbl.pdf#page=14 |
Clinoril | Sulindac | TABLET;ORAL | 017911 | MERCK | 12/23/2010 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf |
Codeine Sulfate | Codeine Sulfate | TABLET;ORAL | 022402 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf#page=29 |
Codeine Sulfate | Codeine Sulfate | SOLUTION;ORAL | 202245 | HIKMA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202245s009lbl.pdf#page=29 |
Colcrys | Colchicine | TABLET; ORAL | 022353 | AR HOLDING CO INC | 10/16/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf#page=19 |
Colcrys | Colchicine | TABLET;ORAL | 022352 | TAKEDA PHARMS USA | 05/14/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf#page=25 |
Columvi | Glofitamab-Gxbm | INJECTABLE;INTRAVENOUS | 761309 | GENETECH | 06/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf#page=19 |
Combogesic | Acetaminophen; Ibuprofen | TABLET;ORAL | 209471 | AFT Pharmaceuticals | 03/01/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209471s000lbl.pdf#page=28 |
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 | 07/24/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf#page=27 |
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 | 06/30/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761058s018lbl.pdf#page=38 |
Cymbalta | Duloxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021427 | LILLY | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021427s055s057lbl.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 | 03/27/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210656s005lbl.pdf#page=20 |
Daxxify | Daxibotulinumtoxina-Lanm | INJECTABLE;INTRAMUSCULAR | 761127 | REVANCE THERAPEUTICS, INC | 08/11/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761127s002lbl.pdf#page=16 |
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 | 04/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212028s008lbl.pdf#page=22 |
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 | 02/24/2023 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018723s066lbledt.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 | 02/24/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021168s044lbl.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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204150s020lbl.pdf#page=33 |
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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022287s038lbl.pdf#page=24 |
Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | SOLUTION;ORAL | 040776 | OUTLOOK PHARMS | 01/04/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/40776MG.pdf#page=7 |
Diacomit | Stiripentol | FOR SUSPENSION;ORAL | 207223 | BIOCODEX SA | 08/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17 |
Diacomit | Stiripentol | CAPSULE;ORAL | 206709 | BIOCODEX SA | 08/20/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf#page=17 |
Dilantin | Phenytoin Sodium | CAPSULE;ORAL | 084349 | UPJOHN | 09/07/2022 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/084349s088lbl.pdf#page=21 |
Dilantin | Phenytoin | TABLET, CHEWABLE;ORAL | 084427 | PHARMACIA | 10/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf#page=17 |
Dilantin-125 | Phenytoin | SUSPENSION;ORAL | 008762 | UPJOHN | 03/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf#page=19 |
Dilantin-30 | Phenytoin | SUSPENSION;ORAL | 008762 | UPJOHN | 03/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/008762s066lbl.pdf#page=19 |
Dilaudid | Hydromorphone Hydrochloride | SOLUTION;ORAL | 019891 | RHODES PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf#page=30 |
Dilaudid | Hydromorphone Hydrochloride | TABLET;ORAL | 019892 | RHODES PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf#page=30 |
Dolophine Hydrochloride | Methadone Hydrochloride | SYRUP;ORAL | 006134 | HIKMA | 06/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf#page=36 |
Dolophine Hydrochloride | Methadone Hydrochloride | TABLET;ORAL | 006134 | HIKMA | 06/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/006134s050lbl.pdf#page=36 |
Doral | Quazepam | TABLET;ORAL | 018708 | GALT PHARMS | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018708s029lbl.pdf#page=11 |
Dotarem | Gadoterate Meglumine | SOLUTION;INTRAVENOUS | 204781 | GUERBET | 07/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204781s012lbl.pdf#page=17 |
Drizalma Sprinkle | Duloxetine Hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516 | SUN PHARMA GLOBAL | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212516s005lbl.pdf#page=45 |
Droxia | Hydroxyurea | CAPSULE;ORAL | 016295 | BRISTOL MYERS SQUIBB | 06/07/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016295s057lbl.pdf#page=16 |
Duetact | Glimepiride; Pioglitazone Hydrochloride | TABLET;ORAL | 021925 | TAKEDA PHARMS USA | 12/21/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021925s017lbl.pdf#page=39 |
Duexis | Famotidine; Ibuprofen | TABLET;ORAL | 022519 | HORIZON | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022519s013lbl.pdf#page=25 |
Duragesic-100 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
Duragesic-12 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
Duragesic-25 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
Duragesic-37 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
Duragesic-50 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
Duragesic-75 | Fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 019813 | JANSSEN PHARMS | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019813s081lbl.pdf#page=52 |
Duzallo | Allopurinol; Lesinurad | TABLET;ORAL | 209203 | IRONWOOD PHARMS INC | 08/18/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209203s000lbl.pdf#page=27 |
Dyanavel XR | Amphetamine | SUSPENSION, EXTENDED RELEASE;ORAL | 208147 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 10 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 15 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 20 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dyanavel XR 5 | Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526 | TRIS PHARMA INC | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208147Orig1s013,210526Orig1s003lbledt#page=25 |
Dysport | Abobotulinumtoxina | INJECTABLE; INJECTION | 125274 | IPSEN BIOPHARM LTD | 01/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125274s123lbl.pdf#page=30 |
EC-Naprosyn | Naproxen | TABLET, DELAYED RELEASE;ORAL | 020067 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf#page=23 |
Edluar | Zolpidem Tartrate | TABLET;SUBLINGUAL | 021997 | MYLAN SPECIALITY LP | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf#page=23 |
Effexor | Venlafaxine Hydrochloride | TABLET;ORAL | 020151 | WYETH PHARMS INC | 12/12/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020151s031s055s058s060lbl.pdf#page=34 |
Effexor XR | Venlafaxine Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020699 | UPJOHN | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020699s118lbl.pdf#page=41 |
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 |
Elrexfio | Elranatamab-Bcmm | INJECTABLE; SUBCUTANEOUS | 761345 | PFIZER | 08/14/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761345s000lbl.pdf#page=22 |
Elucirem | Gadopiclenol | INJECTABLE;INTRAVENOUS | 216986 | LIEBEL-FLARSHEIM COMPANY | 09/21/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf#page=17 |
Elyxyb | Celecoxib | SOLUTION;ORAL | 212157 | BDSI | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf#page=24 |
Embeda | Morphine Sulfate; Naltrexone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022321 | ALPHARMA PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022321s030lbl.pdf#page=30 |
Emsam | Selegiline | FILM, EXTENDED RELEASE;TRANSDERMAL | 021336 | SOMERSET | 07/14/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021336s014lbl.pdf#page=34 |
Enbrel | Etanercept | VIAL; SUBCUTANEOUS | 103795 | IMMUNEX | 06/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf#page=35 |
Enbrel | Etanercept | SYRINGE | 103795 | IMMUNEX | 06/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103795s5594lbl.pdf#page=35 |
Enhertu | Fam-Trastuzumab Deruxtecan-Nxki | INJECTABLE;INJECTION | 761139 | DAIICHI SANKYO | 08/11/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s022lbl.pdf#page=31 |
Enjaymo | Sutimlimab-Jome | INJECTABLE;INJECTION | 761164 | BIOVERATIV THERAPEUTICS INC | 02/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf#page=13 |
Enspryng | Satralizumab-Mwge | INJECTABLE;SUBCUTANEOUS | 761149 | GENETECH, INC | 09/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf#page=16 |
Entyvio | Vedolizumab | INJECTABLE;INJECTION | 125476 | TAKEDA PHARMS USA | 08/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125476s038s039lbl.pdf#page=20 |
Envarsus XR | Tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406 | VELOXIS PHARMS INC | 09/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206406s007lbl.pdf#page=29 |
Eovist | Gadoxetate Disodium | SOLUTION;INTRAVENOUS | 022090 | BAYER HLTHCARE | 12/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090s020lbledt.pdf#page=15 |
Epidiolex | Cannabidiol | SOLUTION;ORAL | 210365 | GW RES LTD | 02/24/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210365s015lbl.pdf#page=32 |
Epkinly | Epcoritamab-Bysp | INJECTABLE;SUBCUTANEOUS | 761324 | GENMAB US | 05/19/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf#page=26 |
Epogen | Epoetin Alfa | VIAL; SINGLE-USE | 103234 | AMGEN | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27 |
Epzicom | Abacavir Sulfate; LAmivudine | TABLET;ORAL | 021652 | VIIV HLTHCARE | 12/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021652s029lbl.pdf#page=28 |
Equetro | Carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710 | VALIDUS PHARMS | 10/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021710s018lbl.pdf#page=27 |
Erelzi | Etanercept-Szzs | INJECTABLE; INJECTION | 761042 | SANDOZ | 11/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761042s018lbl.pdf#page=41 |
Erivedge | Vismodegib | CAPSULE;ORAL | 203388 | GENENTECH | 03/27/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203388s017lbl.pdf#page=15 |
Esomeprazole Strontium | Esomeprazole Strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342 | BELCHER | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202342s007lbl.pdf#page=29 |
Estazolam | Estazolam | TABLET;ORAL | 074921 | MAYNE PHARMA | 02/05/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359235.pdf |
Eticovo | Etanercept-Ykro | INJECTABLE;INJECTION | 761066 | SAMSUNG BIOEPIS CO LTD | 04/25/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761066s000lbl.pdf#page=31 |
Evekeo ODT | Amphetamine Sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 209905 | ARBOR PHARMS LLC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209905s003MedGuide.pdf |
Evenity | Romosozumab-Aqqg | INJECTABLE;INJECTION | 761062 | AMGEN INC | 12/20/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761062s000lbl.pdf#page=19 |
Evista | Raloxifene Hydrochloride | TABLET; ORAL | 022042 | LILLY | 09/13/2007 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf |
Evista | Raloxifene Hydrochloride | TABLET;ORAL | 020815 | LILLY | 06/27/2018 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf |
Exalgo | Hydromorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021217 | SPECGX LLC | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021217s025lbl.pdf#page=31 |
Exjade | Deferasirox | TABLET, FOR SUSPENSION;ORAL | 021882 | NOVARTIS | 07/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021882s033lbl.pdf#page=28 |
Extavia | Interferon Beta-1b | INJECTABLE; SUBCUTANEOUS | 125290 | NOVARTIS PHARMS | 07/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125290s074lbl.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 | 05/08/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf#page=54 |
Farydak | Panobinostat LActate | CAPSULE;ORAL | 205353 | SECURA | 06/06/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf |
Felbatol | Felbamate | TABLET;ORAL | 020189 | MYLAN SPECIALITY LP | 08/31/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf |
Felbatol | Felbamate | SUSPENSION;ORAL | 020189 | MYLAN SPECIALITY LP | 08/31/2012 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf |
Feldene | Piroxicam | CAPSULE;ORAL | 018147 | PFIZER | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf#page=21 |
Fensolvi Kit | Leuprolide Acetate | POWDER;SUBCUTANEOUS | 213150 | TOLMAR | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213150s002lbl.pdf#page=15 |
Fentanyl Citrate | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 077312 | PAR PHARM | 09/07/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf |
Fentanyl Citrate | Fentanyl Citrate | TROCHE/LOZENGE;TRANSMUCOSAL | 078907 | SPECGX LLC | 12/03/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf |
Fentora | Fentanyl Citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | CEPHALON | 11/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021947s038lbl.pdf#page=42 |
Ferriprox | Deferiprone | TABLET;ORAL | 021825 | CHIESI | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf#page=17 |
Ferriprox | Deferiprone | TABLET;ORAL | 212269 | CHIESI | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212269s003lbl.pdf#page=17 |
Ferriprox | Deferiprone | SOLUTION;ORAL | 208030 | CHIESI | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s007lbl.pdf#page=13 |
Fetzima | Levomilnacipran Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 204168 | ALLERGAN | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204168s011lbl.pdf#page=29 |
Filspari | Sparsentan | TABLET;ORAL | 216403 | TRAVERE THERAPEUTICS | 02/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216403s000lbl.pdf#page=22 |
Fintepla | Fenfluramine Hydrochloride | SOLUTION;ORAL | 212102 | ZOGENIX INC | 01/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212102s006lbl.pdf#page=30 |
Fioricet W/ Codeine | Acetaminophen; Butalbital; Caffeine; Codeine Phosphate | CAPSULE;ORAL | 020232 | ACTAVIS LABS UT INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf#page=42 |
Fiorinal W/Codeine | Aspirin; Butalbital; Caffeine; Codeine Phosphate | CAPSULE;ORAL | 019429 | ALLERGAN | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019429s043lbl.pdf#page=39 |
Firdapse | Amifampridine Phosphate | TABLET;ORAL | 208078 | CATALYST PHARMS | 05/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208078s009lbl.pdf#page=12 |
Flector | Diclofenac Epolamine | SYSTEM;TOPICAL | 021234 | INST BIOCHEM | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021234s019lbl.pdf#page=24 |
Flowtuss | Guaifenesin; Hydrocodone Bitartrate | SOLUTION;ORAL | 022424 | BKK PHARMS | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022424s002lbl.pdf#page=26 |
Floxin | Ofloxacin | TABLET;ORAL | 019735 | JANSSEN PHARMS | 02/25/2011 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf |
Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | TABLET;ORAL | 202133 | ALMATICA | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202133s009s016lbl.pdf#page=36 |
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 | 05/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s026,204734s008lbl.pdf#page=12 |
Fosrenol | Lanthanum Carbonate | POWDER;ORAL | 204734 | TAKEDA PHARMS USA | 05/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s026,204734s008lbl.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 | 02/23/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208277s005lbl.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 | 08/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022527s038lbl.pdf#page=27 |
Gimoti | Metoclopramide Hydrochloride | SPRAY, METERED;NASAL | 209388 | EVOKE PHARMA INC | 01/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209388s001lbl.pdf#page=17 |
Gloperba | Colchicine | SOLUTION;ORAL | 210942 | ROMEG | 02/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210942Orig1s001lbl.pdf#page=12 |
Glyxambi | Empagliflozin; Linagliptin | TABLET;ORAL | 206073 | BOEHRINGER INGELHEIM | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s033lbl.pdf#page=32 |
Golytely | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous | FOR SOLUTION;ORAL | 019011 | BRAINTREE | 05/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019011s033lbl.pdf#page=9 |
Gralise | Gabapentin | TABLET;ORAL | 022544 | ALMATICA | 04/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022544Orig1s029lbl.pdf#page=21 |
H.P. Acthar Gel | Repository Corticotropin | INJECTABLE; INJECTION | 022432 | QUESTCOR PHARMA | 10/15/2010 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf |
Hadlima | Adalimumab-Bwwd | INJECTABLE;INJECTION | 761059 | SAMSUNG BIOEPIS CO LTD | 07/11/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059s008lbl.pdf#page=46 |
Halcion | Triazolam | TABLET;ORAL | 017892 | PFIZER | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017892s057lbl.pdf#page=20 |
Halflytely | Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | 021551 | BRAINTREE | 06/03/2013 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM220644.pdf |
Hemangeol | Propranolol Hydrochloride | SOLUTION;ORAL | 205410 | PIERRE FABRE DERMA | 06/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205410s006lbl.pdf#page=11 |
Hemlibra | Emicizumab | INJECTABLE;INJECTION | 761083 | GENENTECH INC | 06/06/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761083s015lbl.pdf#page=22 |
Horizant | Gabapentin Enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399 | ARBOR PHARMS LLC | 04/17/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022399s010lbl.pdf#page=27 |
Hulio | Adalimumab-Fkjp | INJECTABLE;INJECTION | 761154 | MYLAN PHARMS INC | 03/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s003lbl.pdf#page=46 |
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 | 04/14/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761071s015lbl.pdf#page=45 |
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 | 06/16/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761069s042lbl.pdf#page=51 |
Imipramine Hydrochloride | Imipramine Hydrochloride | TABLET;ORAL | 087846 | SPECGX LLC | 06/29/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf#page=3 |
Imjudo | Tremelimumab-Actl | INJECTABLE;INTRAVENOUS | 761289 | ASTRAZENECA | 06/14/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761289s002lbl.pdf#page=31 |
Imjudo | Tremelimumab-Actl | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 761270 | ASTRAZENECA | 11/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf#page=32 |
Incivek | Telaprevir | TABLET;ORAL | 201917 | VERTEX PHARMS | 03/25/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf |
Indocin | Indomethacin | SUPPOSITORY;RECTAL | 017814 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017814s044lbl.pdf#page=24 |
Indocin | Indomethacin | CAPSULE;ORAL | 016059 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016059s101lbl.pdf#page=24 |
Indocin | Indomethacin | SUSPENSION;ORAL | 018332 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018332s042lbl.pdf#page=24 |
Indocin SR | Indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185 | EGALET | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018185s058lbl.pdf#page=25 |
Indomethacin | Indomethacin | CAPSULE;ORAL | 018829 | CHARTWELL MOLECULES | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018829s023lbl.pdf#page=18 |
Indomethacin | Indomethacin | CAPSULE;ORAL | 018851 | HERITAGE | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018851s028lbl.pdf#page=23 |
Indomethacin | Indomethacin | CAPSULE;ORAL | 018858 | RISING | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018858s047lbl.pdf#page=26 |
Inflectra | Infliximab-Dyyb | INJECTABLE;INJECTION | 125544 | CELLTRION INC | 06/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125544s018lbl.pdf#page=61 |
Inpefa | Sotagliflozin | TABLET; ORAL | 216203 | LEXICON PHARMACEUTICALS | 05/26/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216203s000lbl.pdf#page=24 |
Inrebic | Fedratinib Hydrochloride | CAPSULE;ORAL | 212327 | IMPACT | 05/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212327s005lbl.pdf#page=21 |
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 | 07/05/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf#page=56 |
Invokamet XR | Canagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205879 | JANSSEN PHARMS | 07/05/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf#page=56 |
Invokana | Canagliflozin | TABLET;ORAL | 204042 | JANSSEN PHARMS | 07/05/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204042s040lbl.pdf#page=47 |
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 | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf#page=43 |
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 | 07/31/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf#page=34 |
Jentadueto | Linagliptin; METformin Hydrochloride | TABLET;ORAL | 201281 | BOEHRINGER INGELHEIM | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf#page=21 |
Jentadueto XR | Linagliptin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026 | BOEHRINGER INGELHEIM | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208026s024lbl.pdf#page=22 |
Jesduvroq | Daprodustat | TABLET;ORAL | 216951 | GLAXOSMITHKLINE | 02/01/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216951s000lbl.pdf#page=23 |
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 | 07/27/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203414s016lbl.pdf#page=32 |
Keppra | Levetiracetam | TABLET;ORAL | 021035 | UCB INC | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s112,021505s051lbl.pdf#page=31 |
Keppra | Levetiracetam | SOLUTION;ORAL | 021505 | UCB INC | 08/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021035s112,021505s051lbl.pdf#page=31 |
Keppra XR | Levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285 | UCB INC | 08/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022285s034lbl.pdf#page=26 |
Kesimpta | Ofatumumab | SOLUTION;SUBCUTANEOUS | 125326 | NOVARTIS | 09/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125326s075lbl.pdf#page=13 |
Ketek | Telithromycin | TABLET;ORAL | 021144 | SANOFI AVENTIS US | 11/04/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf#page=29 |
Kevzara | Sarilumab | INJECTABLE;INJECTION | 761037 | SANOFI SYNTHELABO | 02/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf#page=31 |
Keytruda | Pembrolizumab | SOLUTION;INTRAVENOUS | 125514 | MERCK SHARP DOHME | 04/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s136lbl.pdf#page=134 |
Khedezla | Desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204683 | OSMOTICA PHARM CORP | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204683s007lbl.pdf#page=24 |
Klonopin | Clonazepam | TABLET;ORAL | 017533 | CHEPLAPHARM | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf#page=24 |
Kombiglyze XR | Metformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678 | ASTRAZENECA AB | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf#page=47 |
Konvomep | Omeprazole; Sodium Bicarbonate | SUSPENSION;ORAL | 213593 | AZURITY | 08/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213593s000lbl.pdf#page=28 |
Korlym | Mifepristone | TABLET;ORAL | 202107 | CORCEPT THERAP | 11/05/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202107s008lbl.pdf#page=20 |
Krystexxa | Pegloticase | INJECTABLE; INJECTION | 125293 | HORIZON PHARMA | 07/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125293s104lbl.pdf#page=18 |
Kynamro | Mipomersen Sodium | SOLUTION;SUBCUTANEOUS | 203568 | KASTLE THERAPS LLC | 03/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf |
Lacosamide | Lacosamide | SOLUTION;ORAL | 204839 | AMNEAL PHARMS | 10/27/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LacosamideTabletsCVMedGuide.pdf |
Lacosamide | Lacosamide | TABLET;ORAL | 204855 | ACTAVIS LABS FL INC | 10/27/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE TABLETSMedGuide.pdf |
Lacosamide | Lacosamide | TABLET;ORAL | 204857 | AMNEAL PHARMS NY | 08/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE ORAL SOLUTIONMed Guide.pdf |
Lamictal | Lamotrigine | TABLET;ORAL | 020241 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65 |
Lamictal CD | Lamotrigine | TABLET, FOR SUSPENSION;ORAL | 020764 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65 |
Lamictal ODT | Lamotrigine | TABLET, ORALLY DISINTEGRATING;ORAL | 022251 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf#page=65 |
Lamictal XR | Lamotrigine | TABLET, EXTENDED RELEASE;ORAL | 022115 | GLAXOSMITHKLINE LLC | 03/31/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022115s029lbl.pdf#page=51 |
Lamictal XR | Lamotrigine | TABLET, EXTENDED RELEASE; ORAL | 022509 | SMITHKLINE BEECHAM | 01/29/2010 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.pdf#page=39 |
Lamisil | Terbinafine Hydrochloride | GRANULE;ORAL | 022071 | NOVARTIS | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf#page=10 |
Lamisil | Terbinafine Hydrochloride | TABLET;ORAL | 020539 | NOVARTIS | 03/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf#page=11 |
Lamivudine, Nevirapine and Zidovudine | Lamivudine; Nevirapine; Zidovudine | TABLET;ORAL | 205626 | MICRO LABS | 08/13/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205626s000lbl.pdf#page=50 |
Lariam | Mefloquine Hydrochloride | TABLET;ORAL | 019591 | ROCHE | 04/29/2011 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf#page=13 |
Latuda | Lurasidone Hydrochloride | TABLET;ORAL | 200603 | SUNOVION PHARMS INC | 12/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200603s035lbl.pdf#page=62 |
Lazanda | Fentanyl Citrate | SPRAY, METERED;NASAL | 022569 | BTCP PHARMA | 12/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022569s030lbl.pdf#page=35 |
Lemtrada | Alemtuzumab | INJECTABLE;INJECTION | 103948 | GENZYME | 05/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103948s5185lbl.pdf#page=30 |
Leqembi | Ecanemab-Irmb | INJECTABLE;INTRAVENOUS | 761269 | EISAI INC | 07/06/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s001lbl.pdf#page=21 |
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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s057,021365s040lbl.pdf#page=30 |
Lexapro | Escitalopram Oxalate | SOLUTION;ORAL | 021365 | ALLERGAN | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021323s057,021365s040lbl.pdf#page=30 |
Librax | Chlordiazepoxide Hydrochloride; Clidinium Bromide | CAPSULE;ORAL | 012750 | BAUSCH | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012750s068lbl.pdf#page=13 |
Librium | Chlordiazepoxide Hydrochloride | CAPSULE;ORAL | 012249 | VALEANT PHARM INTL | 12/16/2016 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf#page=8 |
Libtayo | Cemiplimab-Rwlc | INJECTABLE;INTRAVENOUS | 761097 | REGENERON PHARMACEUTICALS | 04/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761097s016lbl.pdf#page=36 |
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 | 06/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf#page=23 |
Lithium Carbonate | Lithium Carbonate | CAPSULE;ORAL | 017812 | HIKMA | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf#page=19 |
Lithium Carbonate | Lithium Carbonate | TABLET;ORAL | 018558 | HIKMA | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf#page=19 |
Lithium Citrate | Lithium Citrate | SYRUP;ORAL | 018421 | HIKMA | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017812s036,018421s035,018558s030lbl.pdf#page=19 |
Loreev XR | Lorazepam | CAPSULE, EXTENDED RELEASE;ORAL | 214826 | Almatica Pharma | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214826s003lbl.pdf#page=16 |
Lotronex | Alosetron Hydrochloride | TABLET;ORAL | 021107 | SEBELA IRELAND LTD | 04/03/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf |
Lumoxiti | Moxetumomab Pasudotox-Tdfk | INJECTABLE;INJECTION | 761104 | INNATE PHARMA | 08/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf#page=18 |
Lunesta | Eszopiclone | TABLET;ORAL | 021476 | SUNOVION PHARMS INC | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf#page=26 |
Lunsumio | Mosunetuzumab-Axgb | INJECTABLE;INTRAVENOUS | 761263 | GENENTECH, INC | 12/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761263s000lbl.pdf#page=21 |
Lupaneta Pack | Leuprolide Acetate for Depot Suspension, Norethindrone Acetate Usp | INJECTABLE;INTRAMUSCULAR; TABLET;ORAL | 203696 | GLENMARK PHARMACEUTICALS | 08/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203696s005s006lbl.pdf#page=30 |
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 | 04/14/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020263s053lbl.pdf#page=26 |
Luvox | Fluvoxamine Maleate | TABLET;ORAL | 021519 | ANI PHARMS | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021519s026lbl.pdf#page=32 |
Luvox CR | Fluvoxamine Maleate | CAPSULE, EXTENDED RELEASE;ORAL | 022033 | JAZZ PHARMS | 01/04/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf#page=26 |
Lybalvi | Olanzapine; Samidorphan L-Malate | TABLET;ORAL | 213378 | ALKERMES INC | 05/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf#page=40 |
Lynparza | Olaparib | TABLET;ORAL | 208558 | ASTRAZENECA | 08/26/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s026lbl.pdf#page=54 |
Lynparza | Olaparib | CAPSULE;ORAL | 206162 | ASTRAZENECA | 09/27/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16 |
Lyrica | Pregabalin | SOLUTION;ORAL | 022488 | UPJOHN | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56 |
Lyrica | Pregabalin | CAPSULE;ORAL | 021446 | UPJOHN | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021446s036,022488s014lbl.pdf#page=56 |
Lyrica CR | Pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501 | UPJOHN | 04/03/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29 |
Magnevist | Gadopentetate Dimeglumine | INJECTABLE;INJECTION | 021037 | BAYER HLTHCARE | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13 |
Magnevist | Gadopentetate Dimeglumine | INJECTABLE;INJECTION | 019596 | BAYER HLTHCARE | 07/25/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12 |
Marplan | Isocarboxazid | TABLET;ORAL | 011961 | VALIDUS PHARMS INC | 11/08/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf#page=16 |
Mavenclad | Cladribine | TABLET;ORAL | 022561 | EMD SERONO INC | 09/19/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022561s006lbl.pdf#page=29 |
Mayzent | Siponimod Fumaric Acid | TABLET;ORAL | 209884 | NOVARTIS | 08/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209884s016s018lbl.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 | 03/23/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s026lbl.pdf#page=16 |
Mircera | Methoxy Polyethylene Glycol-Epoetin Beta | INJECTABLE; SUBCUTANEOUS | 126164 | Vifor International Inc | 04/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/126164s087lbl.pdf#page=27 |
Mircera | Methoxy Polyethylene Glycol-Epoetin Beta | SOLUTION; INJECTION | 125164 | HOFFMAN-LA ROCHE | 03/31/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125164s087lblcorretion.pdf#page=23 |
Mitigare | Colchicine | CAPSULE;ORAL | 204820 | HIKMA AMERICAS | 09/26/2014 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204820s000lbl.pdf#page=11 |
Mitigare | Colchicine | CAPSULE;ORAL | 204820 | HIKMA INTL PHARMS | 09/26/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf |
Mobic | Meloxicam | SUSPENSION;ORAL | 021530 | AVONDALE PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021530s017lbl.pdf#page=16 |
Mobic | Meloxicam | TABLET;ORAL | 020938 | BOEHRINGER INGELHEIM | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf#page=16 |
Morphabond ER | Morphine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 206544 | DAIICHI SANKYO INC | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf#page=38 |
Morphine Sulfate | Morphine Sulfate | TABLET;ORAL | 022207 | HIKMA | 06/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022207s010lbl.pdf#page=26 |
Morphine Sulfate | Morphine Sulfate | SOLUTION;ORAL | 022195 | HIKMA | 07/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022195s019lbl.pdf#page=29 |
Morphine Sulfate | Morphine Sulfate | SOLUTION;ORAL | 201517 | LANNETT CO INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf#page=29 |
Motpoly XR | Lacosamide | CAPSULE, EXTENDED RELEASE;ORAL | 216185 | Aucta Pharmaceuticals | 05/04/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216185s000lbl.pdf#page=22 |
Motrin | Ibuprofen | TABLET;ORAL | 017463 | MCNEIL CONSUMER | 09/10/2007 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017463s104lbl.pdf#page=13 |
Mounjaro | Tirzepatide | INJECTABLE; SUBCUTANEOUS | 215866 | ELI LILLY AND COMPANY | 07/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215866s002s006lbl.pdf#page=20 |
Movantik | Naloxegol Oxalate | TABLET;ORAL | 204760 | REDHILL | 04/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf#page=16 |
Moviprep | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | FOR SOLUTION;ORAL | 021881 | SALIX PHARMS | 05/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021881s023lbl.pdf#page=13 |
Moxifloxacin Hydrochloride | Moxifloxacin Hydrochloride | SOLUTION;INTRAVENOUS | 205572 | FRESENIUS KABI USA | 07/26/2016 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205572s007lbl.pdf#page=49 |
MS Contin | Morphine Sulfate | TABLET, EXTENDED RELEASE;ORAL | 019516 | PURDUE PHARMA LP | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019516s057lbl.pdf#page=29 |
Multaq | Dronedarone Hydrochloride | TABLET;ORAL | 022425 | SANOFI AVENTIS US | 11/16/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=22 |
Multihance | Gadobenate Dimeglumine | INJECTABLE;INTRAVENOUS | 021357 | BRACCO | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34 |
Multihance Multipack | Gadobenate Dimeglumine | INJECTABLE;INTRAVENOUS | 021358 | BRACCO | 11/02/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s016s017,021358s015s016lbl.pdf#page=34 |
Myalept | Metreleptin | INJECTABLE;INJECTION | 125390 | AEGERION | 02/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125390s024lbl.pdf#page=16 |
Mydayis | Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 022063 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf#page=22 |
Myfortic | Mycophenolic Sodium | TABLET, DELAYED RELEASE;ORAL | 050791 | NOVARTIS | 03/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050791s035lbl.pdf#page=23 |
Myobloc | Botulinum Toxin Type B | VIAL | 103846 | ELAN PHARM | 03/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103846s5195lbl.pdf#page=17 |
Mysoline | Primidone | TABLET;ORAL | 009170 | VALEANT | 06/10/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009170Orig1s040lbl.pdf#page=7 |
Nalfon | Fenoprofen Calcium | CAPSULE;ORAL | 017604 | XSPIRE PHARMA | 04/28/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf |
Naprelan | Naproxen Sodium | TABLET, EXTENDED RELEASE;ORAL | 020353 | ALMATICA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf#page=23 |
Naprosyn | Naproxen | TABLET;ORAL | 017581 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s064lbl.pdf#page=23 |
Naprosyn | Naproxen | SUSPENSION;ORAL | 018965 | ATNAHS PHARMA US | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018965s027lbl.pdf#page=23 |
Nardil | Phenelzine Sulfate | TABLET;ORAL | 011909 | PARKE DAVIS | 08/02/2007 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088660.pdf |
Natpara | Parathyroid Hormone | INJECTABLE;INJECTION | 125511 | NPS PHARMS INC | 07/01/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s016lbl.pdf#page=18 |
Nayzilam | Midazolam | SPRAY;NASAL | 211321 | UCB INC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211321s008lbl.pdf#page=26 |
Nesina | Alogliptin Benzoate | TABLET;ORAL | 022271 | TAKEDA PHARMS USA | 07/27/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf#page=28 |
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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021153s060,021957s027,022101s024lbl.pdf#page=40 |
Nexium | Esomeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022101 | ASTRAZENECA | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021153s060,021957s027,022101s024lbl.pdf#page=40 |
Nexium | Esomeprazole Magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957 | ASTRAZENECA | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021153s060,021957s027,022101s024lbl.pdf#page=40 |
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 | 07/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022304s024lbl.pdf#page=36 |
Nucynta | Tapentadol Hydrochloride | SOLUTION;ORAL | 203794 | COLLEGIUM PHARM INC | 07/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203794s010lbl.pdf#page=35 |
Nucynta ER | Tapentadol Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | COLLEGIUM PHARM INC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200533s023lbl.pdf#page=37 |
Nulojix | Belatacept | INJECTABLE; INJECTION | 125288 | BRISTOL MYERS SQUIBB | 07/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49 |
Nulytely | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | FOR SOLUTION;ORAL | 019797 | BRAINTREE | 05/14/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf |
Nulytely-Flavored | Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | FOR SOLUTION;ORAL | 019797 | BRAINTREE | 05/14/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf |
Nuvigil | Armodafinil | TABLET;ORAL | 021875 | CEPHALON | 02/07/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf#page=24 |
Obredon | Guaifenesin; Hydrocodone Bitartrate | SOLUTION;ORAL | 205474 | SOVEREIGN PHARMS | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205474s005lbl.pdf#page=23 |
Ocaliva | Obeticholic Acid | TABLET;ORAL | 207999 | INTERCEPT PHARMS INC | 05/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207999s007lbl.pdf#page=22 |
Ocrevus | Ocrelizumab | INJECTABLE;INJECTION | 761053 | GENENTECH INC | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761053s031lbl.pdf#page=20 |
Odomzo | Sonidegib Phosphate | CAPSULE;ORAL | 205266 | SUN PHARMA GLOBAL | 05/13/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205266s006lbl.pdf#page=13 |
Oleptro | Trazodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022411 | ANGELINI PHARMA | 07/17/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf |
Olumiant | Baricitinib | TABLET;ORAL | 207924 | ELI LILLY AND CO | 05/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s006lbl.pdf#page=26 |
Omniscan | Gadodiamide | INJECTABLE;INJECTION | 022066 | GE HEALTHCARE | 10/23/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1 |
Omniscan | Gadodiamide | INJECTABLE;INJECTION | 020123 | GE HEALTHCARE | 11/07/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1 |
Omontys | Peginesatide Acetate | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 202799 | TAKEDA PHARMS USA | 12/04/2012 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf#page=15 |
Onfi | Clobazam | SUSPENSION;ORAL | 203993 | LUNDBECK PHARMS LLC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf#page=29 |
Onfi | Clobazam | TABLET;ORAL | 202067 | LUNDBECK PHARMS LLC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202067s007,203993s009lbl.pdf#page=29 |
Onglyza | Saxagliptin Hydrochloride | TABLET;ORAL | 022350 | ASTRAZENECA AB | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf#page=31 |
Onsolis | Fentanyl Citrate | FILM;BUCCAL | 022266 | BDSI | 12/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf#page=32 |
Opana | Oxymorphone Hydrochloride | TABLET;ORAL | 021611 | ENDO PHARMS | 10/25/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf#page=27 |
Opana ER | Oxymorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021610 | ENDO PHARMS | 04/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021610s030lbl.pdf#page=31 |
Opana ER | Oxymorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655 | ENDO PHARMS | 10/07/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf#page=26 |
Opdivo | Nivolumab | INJECTABLE;INJECTION | 125554 | BRISTOL MYERS SQUIBB | 02/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s119lbl.pdf#page=135 |
Opsumit | Macitentan | TABLET;ORAL | 204410 | ACTELION | 05/26/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204410s024lbl.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 | 03/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215309s004lbl.pdf#page=19 |
Oriahnn (Copackaged) | Elagolix Sodium,Estradiol,Norethindrone Acetate; Elagolix Sodium | CAPSULE;ORAL | 213388 | ABBVIE INC | 05/29/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213388s003lbl.pdf#page=29 |
Orilissa | Elagolix Sodium | TABLET;ORAL | 210450 | ABBVIE INC | 06/05/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210450s009lbl.pdf#page=27 |
Oseni | Alogliptin Benzoate; Pioglitazone Hydrochloride | TABLET;ORAL | 022426 | TAKEDA PHARMS USA | 07/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022426s012lbl.pdf#page=43 |
Osmoprep | Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | TABLET;ORAL | 021892 | SALIX PHARMS | 11/29/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf#page=13 |
Oxaydo | Oxycodone Hydrochloride | TABLET;ORAL | 202080 | ZYLA | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202080s012lbl.pdf#page=30 |
Oxtellar XR | Oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 202810 | SUPERNUS PHARMS | 12/13/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf |
Oxycodone Hydrochloride | Oxycodone Hydrochloride | SOLUTION;ORAL | 201194 | VISTAPHARM | 07/21/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf#page=33 |
Oxycodone Hydrochloride | Oxycodone Hydrochloride | SOLUTION;ORAL | 200535 | GENUS LIFESCIENCES | 07/21/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf#page=67 |
Oxycontin | Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272 | PURDUE PHARMA LP | 10/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s047lbl.pdf#page=48 |
Oxymorphone Hydrochloride | Oxymorphone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079046 | ACTAVIS ELIZABETH | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf |
Ozempic | Semaglutide | SOLUTION;SUBCUTANEOUS | 209637 | NOVO | 10/06/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf#page=27 |
Pacerone | Amiodarone Hydrochloride | TABLET;ORAL | 075135 | UPSHER SMITH LABS | 11/01/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf |
Palladone | Hydromorphone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021044 | PURDUE PHARMA LP | 04/16/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf |
Palynziq | Pegvaliase-Pqpz | INJECTABLE;INJECTION | 761079 | BIOMARIN PHARM | 11/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf#page=23 |
Pamelor | Nortriptyline Hydrochloride | SOLUTION;ORAL | 018012 | SPECGX LLC | 07/28/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf |
Pamelor | Nortriptyline Hydrochloride | CAPSULE;ORAL | 018013 | SPECGX LLC | 04/09/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf#page=15 |
Pancreaze | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022523 | VIVUS INC | 04/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022523s013lbl.pdf#page=16 |
Parnate | Tranylcypromine Sulfate | TABLET;ORAL | 012342 | CONCORDIA | 01/04/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012342s064lbl.pdf#page=18 |
Paxil | Paroxetine Hydrochloride | TABLET;ORAL | 020031 | APOTEX TECHNOLOGIES | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020031s082,020710s050lbl.pdf#page=39 |
Paxil | Paroxetine Hydrochloride | SUSPENSION;ORAL | 020710 | APOTEX TECHNOLOGIES | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020031s082,020710s050lbl.pdf#page=39 |
Paxil CR | Paroxetine Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020936 | APOTEX TECHNOLOGIES | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020936s057s064lbl.pdf#page=30 |
Peganone | Ethotoin | TABLET;ORAL | 010841 | RECORDATI RARE | 02/27/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf |
Pegasys | Peginterferon Alfa-2a | VIAL; SUBCUTANEOUS | 103964 | HOFFMAN-LA ROCHE | 03/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39 |
Pegasys | Peginterferon Alfa-2a | SYRINGE | 103964 | HOFFMAN-LA ROCHE | 03/24/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39 |
Pegintron | Peginterferon Alfa-2b | SYRINGE | 103949 | SCHERING | 12/21/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103949s5313lbl.pdf#page=29 |
Pennsaid | Diclofenac Sodium | SOLUTION;TOPICAL | 020947 | NUVO PHARMS INC | 05/09/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf |
Pennsaid | Diclofenac Sodium | SOLUTION;TOPICAL | 204623 | HORIZON | 06/07/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204623Orig1s010lbl.pdf#page=20 |
Percocet | Acetaminophen; Oxycodone Hydrochloride | TABLET;ORAL | 040330 | VINTAGE PHARMS LLC | 03/04/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/040330s052lbl.pdf |
Percodan | Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate | TABLET;ORAL | 007337 | ENDO PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf#page=30 |
Percodan | Aspirin; Oxycodone Hydrochloride | TABLET;ORAL | 007337 | ENDO PHARMS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007337s053lbl.pdf#page=30 |
Perforomist | Formoterol Fumarate | SOLUTION;INHALATION | 022007 | MYLAN SPECLT | 05/29/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf#page=19 |
Pertzye | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022175 | DIGESTIVE CARE INC | 09/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022175s008lbl.pdf#page=13 |
Pexeva | Paroxetine Mesylate | TABLET;ORAL | 021299 | SEBELA IRELAND LTD | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021299s035s038lbl.pdf#page=18 |
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 | 07/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.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 | 03/24/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204026s031lbl.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 | 08/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213498s004lbl.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 | 08/08/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.pdf#page=45 |
Prevacid | Lansoprazole | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 021428 | TAKEDA PHARMS USA | 08/08/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022056s026lbl.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 | 03/23/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204442s013lbl.pdf#page=48 |
Procrit | Epoetin Alfa | VIAL; SINGLE-USE | 103234 | AMGEN | 07/25/2018 | https://www.fda.gov/media/73511/download |
Prohance | Gadoteridol | INJECTABLE;INJECTION | 020131 | BRACCO | 12/19/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020131s035lbl.pdf#page16 |
Prohance Multipack | Gadoteridol | INJECTABLE;INJECTION | 021489 | BRACCO | 05/06/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf#page=16 |
Prolia | Denosumab | INJECTABLE; SUBCUTANEOUS | 125320 | AMGEN | 01/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125320s211lbl.pdf#page=31 |
Promacta | Eltrombopag Olamine | TABLET;ORAL | 022291 | NOVARTIS | 03/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291s037,207027s017lbl.pdf#page=35 |
Promacta Kit | Eltrombopag Olamine | FOR SUSPENSION;ORAL | 207027 | NOVARTIS | 03/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022291s037,207027s017lbl.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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020987s060,022020s023lbl.pdf#page=31 |
Protonix | Pantoprazole Sodium | TABLET, DELAYED RELEASE;ORAL | 020987 | WYETH PHARMS | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020987s060,022020s023lbl.pdf#page=31 |
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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018936 s112lbl.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 | 06/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022580s023lbl.pdf#page=44 |
Qtern | Dapagliflozin; Saxagliptin Hydrochloride | TABLET;ORAL | 209091 | ASTRAZENECA AB | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s006lbl.pdf#page=37 |
Qternmet XR | Dapagliflozin; METformin Hydrochloride; Saxagliptin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 210874 | ASTRAZENECA AB | 01/24/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210874s003lbl.pdf#page=47 |
Qualaquin | Quinine Sulfate | CAPSULE;ORAL | 021799 | SUN PHARM INDUSTRIES | 06/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021799s029lbl.pdf#page=26 |
Qudexy XR | Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122 | UPSHER SMITH LABS | 12/02/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205122s014lbl.pdf#page=54 |
Quillichew ER | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 207960 | NEXTWAVE PHARMS | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207960s012lbl.pdf#page=21 |
Quillivant XR | Methylphenidate Hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 202100 | NEXTWAVE | 06/25/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202100s018lbl.pdf#page=21 |
Quviviq | Daridorexant | TABLET; ORAL | 214985 | IDORSIA PHARMACEUTICALS LTD. | 11/08/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214985s002lbl.pdf#page=22 |
Rapamune | Sirolimus | SOLUTION;ORAL | 021083 | PF PRISM CV | 01/02/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021083s067,021110s085lbl.pdf#page=43 |
Rapamune | Sirolimus | TABLET;ORAL | 021110 | PF PRISM CV | 08/09/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021110s086lbl.pdf#page=43 |
Ravicti | Glycerol Phenylbutyrate | LIQUID;ORAL | 203284 | HORIZON THERAP | 09/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203284s012lbl.pdf#page=27 |
Rebetol | Ribavirin | CAPSULE;ORAL | 020903 | MERCK SHARP DOHME | 03/16/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf#page=26 |
Rebetol | Ribavirin | SOLUTION;ORAL | 021546 | SCHERING | 03/16/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020903s057,021546s013lbl.pdf#page=26 |
Rebif | Interferon Beta-1a | SYRINGE | 103780 | SERONO INC | 07/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103780s5214lbl.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 | 08/16/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214133s003lbl.pdf#page=3 |
Reglan | Metoclopramide Hydrochloride | TABLET;ORAL | 017854 | ANI PHARMS | 08/29/2017 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf |
Reglan | Metoclopramide Hydrochloride | INJECTABLE;INJECTION | 017862 | HIKMA | 11/18/2010 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf |
Reglan ODT | Metoclopramide Hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021793 | MEDA PHARMS | 11/30/2011 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf |
Regranex | Becaplermin | GEL; TOPICAL | 103691 | SMITH AND NEPHEW | 08/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf#page=8 |
Relistor | Methylnaltrexone Bromide | SOLUTION;SUBCUTANEOUS | 021964 | SALIX PHARMS | 03/14/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf#page=24 |
Relistor | Methylnaltrexone Bromide | TABLET;ORAL | 208271 | SALIX | 03/14/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf#page=24 |
Remeron | Mirtazapine | TABLET;ORAL | 020415 | ORGANON USA INC | 11/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23 |
Remeron Soltab | Mirtazapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021208 | ORGANON USA INC | 11/18/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23 |
Remicade | Infliximab | VIAL | 103772 | CENTOCOR INC | 10/05/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf#page=50 |
Renflexis | Infliximab-Abda | INJECTABLE;INJECTION | 761054 | SAMSUNG BIOEPIS CO LTD | 06/26/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf#page=52 |
Restoril | Temazepam | CAPSULE;ORAL | 018163 | SPECGX LLC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018163s071lbl.pdf#page=17 |
Retacrit | Epoetin Alfa-Epbx | INJECTABLE;INJECTION | 125545 | HOSPIRA INC | 06/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125545s005lbl.pdf#page=31 |
Revlimid | Lenalidomide | CAPSULE;ORAL | 021880 | CELGENE | 03/24/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf#page=48 |
Rexulti | Brexpiprazole | TABLET;ORAL | 205422 | OTSUKA | 05/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205422s009lbl.pdf#page=36 |
Reyvow | Lasmiditan Succinate | TABLET;ORAL | 211280 | ELI LILLY AND CO | 09/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211280s008lbl.pdf#page=15 |
Rezira | Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | SOLUTION;ORAL | 022442 | PERSION | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf#page=26 |
Riabni | Rituximab-Arrx | INJECTABLE;INJECTION | 761140 | AMGEN INC | 06/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761140s001lbl.pdf#page=41 |
Rinvoq | Upadacitinib | TABLET, EXTENDED RELEASE;ORAL | 211675 | ABBVIE INC | 06/22/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211675s017lbl.pdf#page=71 |
Ritalin | Methylphenidate Hydrochloride | TABLET;ORAL | 010187 | NOVARTIS | 06/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010187s093lbl.pdf#page=13 |
Ritalin LA | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021284 | NOVARTIS | 06/26/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021284s043lbl.pdf#page=17 |
Ritalin-SR | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 018029 | NOVARTIS | 11/19/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/010187s091,018029s059lbl.pdf#page=13 |
Rituxan | Rituximab | SOLUTION;INTRAVENOUS | 103705 | GENENTECH | 12/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf#page=56 |
Rituxan Hycela | Rituximab; Hyaluronidase (Human Recombinant) | SOLUTION;SUBCUTANEOUS | 761064 | GENENTECH INC | 06/10/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761064s013lbl.pdf#page=28 |
Roxicodone | Oxycodone Hydrochloride | TABLET;ORAL | 021011 | SPECGX LLC | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021011s011lbl.pdf#page=30 |
Roxybond | Oxycodone Hydrochloride | TABLET;ORAL | 209777 | OHEMO LIFE | 03/04/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf#page=39 |
Rozerem | Ramelteon | TABLET;ORAL | 021782 | TAKEDA PHARMS USA | 11/03/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021782s022lbl.pdf#page=17 |
Ruxience | Rituximab-Pvvr | INJECTABLE;INJECTION | 761103 | PFIZER INC | 11/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761103s005lbl.pdf#page=42 |
Ruzurgi | Amifampridine | TABLET;ORAL | 209321 | JACOBUS PHARM CO INC | 08/21/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf#page=15 |
Rybelsus | Semaglutide | TABLET;ORAL | 213051 | NOVO | 01/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213051s012lbl.pdf#page=24 |
Rybelsus | Semaglutide | TABLET;ORAL | 213182 | NOVO NORDISK INC | 01/16/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23 |
Sabril | Vigabatrin | FOR SOLUTION;ORAL | 022006 | LUNDBECK PHARMS LLC | 10/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf#page=26 |
Sabril | Vigabatrin | TABLET;ORAL | 020427 | LUNDBECK PHARMS LLC | 10/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020427s025,022006s026lbl.pdf#page=26 |
Samsca | Tolvaptan | TABLET;ORAL | 022275 | OTSUKA | 04/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022275s017lbl.pdf#page=19 |
Sarafem | Fluoxetine Hydrochloride | TABLET;ORAL | 021860 | APIL | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021860s015lbl.pdf#page=32 |
Savaysa | Edoxaban Tosylate | TABLET;ORAL | 206316 | DAIICHI SANKYO INC | 11/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206316s016lbl.pdf#page=35 |
Savella | Milnacipran Hydrochloride | TABLET;ORAL | 022256 | ALLERGAN | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022256s028lbl.pdf#page=31 |
Saxenda | Liraglutide Recombinant | SOLUTION;SUBCUTANEOUS | 206321 | NOVO | 04/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206321s016lbl.pdf#page=30 |
Seglentis | Celecoxib; Tramadol Hydrochloride | TABLET;ORAL | 213426 | KOWA PHARMS | 10/15/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213426s000lbl.pdf#page=56 |
Segluromet | Ertugliflozin; METformin Hydrochloride | TABLET;ORAL | 209806 | MERCK SHARP DOHME | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209806s009lbl.pdf#page=33 |
Selzentry | Maraviroc | SOLUTION;ORAL | 208984 | VIIV HLTHCARE | 10/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43 |
Selzentry | Maraviroc | TABLET;ORAL | 022128 | VIIV HLTHCARE | 10/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128s019,208984s002lbl.pdf#page=43 |
Serevent | Salmeterol Xinafoate | POWDER;INHALATION | 020692 | GLAXOSMITHKLINE | 07/22/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf#page=35 |
Seroquel | Quetiapine Fumarate | TABLET;ORAL | 020639 | ASTRAZENECA | 01/31/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020639s072lbl.pdf#page=49 |
Seroquel XR | Quetiapine Fumarate | TABLET, EXTENDED RELEASE;ORAL | 022047 | ASTRAZENECA | 01/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022047s046lbl.pdf#page=53 |
Sertraline | Sertraline Hydrochloride | CAPSULE;ORAL | 215133 | ALMATICA PHARMA | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215133s001lbl.pdf#page=27 |
Signifor | Pasireotide Diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | RECORDATI RARE | 01/15/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200677s006lbl.pdf#page=15 |
Signifor LAr Kit | Pasireotide Pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | RECORDATI RARE | 07/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf#page=27 |
Siklos | Hydroxyurea | TABLET;ORAL | 208843 | ADDMEDICA SAS | 12/07/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208843s003lbl.pdf#page=18 |
Silenor | Doxepin Hydrochloride | TABLET;ORAL | 022036 | CURRAX | 10/29/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf#page=19 |
Siliq | Brodalumab | INJECTABLE;INJECTION | 761032 | VALEANT LUXEMBOURG | 01/22/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf#page=13 |
Simponi | Golimumab | INJECTABLE; INJECTION | 125289 | CENTOCOR ORTHO BIOTECH INC | 09/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf#page=38 |
Simponi Aria | Golimumab | INJECTABLE; INJECTION | 125433 | JANSSEN BIOTECH | 02/01/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf#page=34 |
Sinequan | Doxepin Hydrochloride | CAPSULE;ORAL | 016798 | PFIZER | 07/14/2014 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089129.pdf |
Singulair | Montelukast Sodium | TABLET;ORAL | 020829 | MSD MERCK CO | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s076,021409s052lbl.pdf#page=25 |
Singulair | Montelukast Sodium | TABLET, CHEWABLE;ORAL | 020830 | MSD MERCK CO | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25 |
Singulair | Montelukast Sodium | GRANULE;ORAL | 021409 | MERCK | 02/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf#page=25 |
Sirturo | Bedaquiline Fumarate | TABLET;ORAL | 204384 | JANSSEN THERAP | 12/09/2015 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204384s016lbl.pdf#page=28 |
Skyrizi | Risankizumab-Rzaa | INJECTABLE;INJECTION | 761105 | ABBVIE INC | 09/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s018lbl.pdf#page=30 |
Skyrizi | Risankizumab-Rzaa | INJECTABLE;SUBCUTANEOUS | 761262 | ABBVIE INC | 09/23/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf#page=30 |
Sodium Oxybate | Sodium Oxybate | SOLUTION;ORAL | 202090 | HIKMA | 01/03/2022 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18 |
Sohonos | Paloverotene | CAPSULE;ORAL | 215559 | IPSEN BIOPHARMACEUTICALS | 08/16/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215559s000lbl.pdf#page=20 |
Solaraze | Diclofenac Sodium | GEL;TOPICAL | 021005 | FOUGERA PHARMS | 11/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021005s024lbl.pdf#page=22 |
Solaraze | Diclofenac Sodium | GEL;TOPICAL | 021005 | FOUGERA PHARMS | 04/28/2021 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf |
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 | 02/22/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019821s029lbl.pdf#page=30 |
Sotret | Isotretinoin | CAPSULE;ORAL | 076041 | SUN PHARM INDS LTD | 04/12/2012 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Sotret.pdf |
Sotyktu | Deucravacitinib | TABLET;ORAL | 214958 | BRISTOL MYERS SQUIBB | 09/09/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214958s000lbl.pdf#page=19 |
Spevigo | Spesolimab-Sbzo | INJECTABLE;INTRAVENOUS | 761244 | Boehringer Ingelheim Pharmaceuticals, Inc | 09/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf#page=11 |
Spravato | Esketamine Hydrochloride | SPRAY;NASAL | 211243 | JANSSEN PHARMS | 01/03/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s004lbl.pdf#page=42 |
Spritam | Levetiracetam | TABLET, FOR SUSPENSION;ORAL | 207958 | APRECIA PHARMS | 01/19/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207958s019lbl.pdf#page=36 |
Sprix | Ketorolac Tromethamine | SPRAY, METERED;NASAL | 022382 | ZYLA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022382s021lbl.pdf#page=22 |
Stavzor | Valproic Acid | CAPSULE, DELAYED RELEASE;ORAL | 022152 | BIONPHARMA INC | 11/30/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022152s009lbl.pdf#page=42 |
Steglatro | Ertugliflozin | TABLET;ORAL | 209803 | MERCK SHARP DOHME | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209803s006lbl.pdf#page=25 |
Steglujan | Ertugliflozin; Sitagliptin Phosphate | TABLET;ORAL | 209805 | MERCK SHARP DOHME | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209805s012lbl.pdf#page=31 |
Stelara | Ustekinumab | INJECTABLE;INJECTION | 761044 | JANSSEN BIOTECH | 03/06/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761044s009lbl.pdf#page=37 |
Stelara | Ustekinumab | INJECTABLE; INJECTION | 125261 | CENTOCOR ORTHO BIOTECH INC | 03/06/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125261s158,761044s009lbl.pdf#page=36 |
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 |
Suflave | Polyethylene Glycol 3350; Sodium Sulfate; Potassium Chloride; Magnesium Sulfate; Sodium Chloride | SOLUTION;ORAL | 215344 | BRAINTREE LABORATORIES | 06/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215344s000lbl.pdf#page=14 |
Sunosi | Solriamfetol Hydrochloride | TABLET;ORAL | 211230 | JAZZ | 06/28/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211230s009lbl.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 | 05/25/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022445s010lbl.pdf#page=17 |
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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021520s055lbl.pdf#page=42 |
Symlin | Pramlintide Acetate | INJECTABLE;SUBCUTANEOUS | 021332 | ASTRAZENECA AB | 12/18/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf |
Sympazan | Clobazam | FILM;ORAL | 210833 | AQUESTIVE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210833s004lbl.pdf#page=26 |
Symproic | Naldemedine Tosylate | TABLET;ORAL | 208854 | BDSI | 01/24/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf#page=13 |
Synalgos-DC | Aspirin; Caffeine; Dihydrocodeine Bitartrate | CAPSULE;ORAL | 011483 | SUN PHARM INDUSTRIES | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011483s034lbl.pdf#page=28 |
Synarel | Nafarelin Acetate | SPRAY, METERED;NASAL | 019886 | PFIZER | 01/31/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019886s039lbl.pdf#page=28 |
Synjardy | Empagliflozin; METformin Hydrochloride | TABLET;ORAL | 206111 | BOEHRINGER INGELHEIM | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf#page=42 |
Synjardy XR | Empagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658 | BOEHRINGER INGELHEIM | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf#page=42 |
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 | 05/26/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s026lbl.pdf#page=46 |
Tafinlar | Dabrafenib | TABLET;ORAL | 217514 | NOVARTIS PHARMACEUTICALS | 03/16/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217514s000lbl.pdf#page=46 |
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 |
Talvey | Talquetamab-Tgvs | INJECTABLE; SUBCUTANEOUS | 761342 | JANSSEN BIOTECH | 08/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf#page=30 |
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 | 05/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761034s049s051lbl.pdf#page=62 |
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 |
Tecvayli | Teclistamab-Cqyv | INJECTABLE; SUBCUTANEOUS | 761291 | JANSSEN BIOTECH | 08/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761291s004lbl.pdf#page=281 |
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 | 03/24/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020785s071lbl.pdf#page=21 |
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 | 07/26/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761208s005lbl.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 | 05/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020505s065,020844s056lbl.pdf#page=56 |
Topamax | Topiramate | TABLET;ORAL | 020505 | JANSSEN PHARMS | 05/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020505s065,020844s056lbl.pdf#page=56 |
Topamax Sprinkle | Topiramate | CAPSULE;ORAL | 020844 | JANSSEN PHARMS | 05/03/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020505s065,020844s056lbl.pdf#page=56 |
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 | 06/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf#page=16 |
Transderm Scop | Scopolamine | SYSTEM;TRANSDERMAL | 017874 | BAXTER HLTHCARE CORP | 03/01/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017874s043s044lbl.pdf#page=20 |
Tranxene | Clorazepate Dipotassium | CAPSULE;ORAL | 017105 | RECORDATI RARE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf#page=14 |
Tranxene | Clorazepate Dipotassium | TABLET;ORAL | 017105 | RECORDATI RARE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf#page=14 |
Tranxene SD | Clorazepate Dipotassium | TABLET;ORAL | 017105 | RECORDATI RARE | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017105s085lbl.pdf#page=14 |
Trazodone Hydrochloride | Trazodone Hydrochloride | TABLET;ORAL | 071196 | APOTEX INC | 04/20/2020 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf#page=3 |
Trelegy Ellipta | Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | POWDER;INHALATION | 209482 | GLAXOSMITHKLINE | 09/09/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf#page=33 |
Tremfya | Guselkumab | INJECTABLE;INJECTION | 761061 | JANSSEN BIOTECH | 07/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf#page=15 |
Treximet | Naproxen Sodium; Sumatriptan Succinate | TABLET;ORAL | 021926 | CURRAX | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021926s017s018lbl.pdf#page=32 |
Tridione | Trimethadione | SOLUTION;ORAL | 005856 | ABBVIE | 06/07/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf |
Tridione | Trimethadione | CAPSULE;ORAL | 005856 | ABBVIE | 06/07/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf |
Tridione | Trimethadione | TABLET;ORAL | 005856 | ABBVIE | 06/07/2016 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf |
Trijardy XR | Empagliflozin; Linagliptin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 212614 | BOEHRINGER INGELHEIM | 06/11/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212614s008s010lbl.pdf#page=42 |
Trileptal | Oxcarbazepine | SUSPENSION;ORAL | 021285 | NOVARTIS | 01/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26 |
Trileptal | Oxcarbazepine | TABLET;ORAL | 021014 | NOVARTIS | 01/04/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26 |
Trintellix | Vortioxetine Hydrobromide | TABLET;ORAL | 204447 | TAKEDA PHARMS USA | 09/20/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s024lbl.pdf#page=33 |
Triptodur Kit | Triptorelin Pamoate | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 208956 | ARBOR PHARMS LLC | 04/22/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208956s010lbl.pdf#page=12 |
Triumeq | Abacavir Sulfate; Dolutegravir Sodium; LAmivudine | TABLET;ORAL | 205551 | VIIV HLTHCARE | 06/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf#page=56 |
Triumeq Pd | Abacavir Sulfate; Dolutegravir Sodium; LAmivudine | SUSPENSION;ORAL | 215413 | VIIV HLTHCARE | 06/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205551s31,215413s02lbl.pdf#page=56 |
Trizivir | Abacavir Sulfate; LAmivudine; Zidovudine | TABLET;ORAL | 021205 | VIIV HLTHCARE | 02/17/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021205s038lbl.pdf#page=34 |
Trokendi XR | Topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 201635 | SUPERNUS PHARMS | 10/07/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201635s030lbl.pdf#page=52 |
Troxyca ER | Naltrexone Hydrochloride; Oxycodone Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621 | PFIZER | 05/26/2017 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf#page=32 |
Trudhesa | Dihydroergotamine Mesylate | SPRAY, METERED;NASAL | 213436 | IMPEL NEUROPHARMA | 09/02/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213436s000lbl.pdf#page=22 |
Trulance | Plecanatide | TABLET;ORAL | 208745 | SALIX | 04/13/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208745s011lbl.pdf#page=15 |
Trulicity | Dulaglutide | INJECTABLE;INJECTION | 125469 | ELI LILLY AND CO | 11/17/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf#page=16 |
Truvada | Emtricitabine; Tenofovir Disoproxil Fumarate | TABLET;ORAL | 021752 | GILEAD | 06/23/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021752s061lbl.pdf#page=35 |
Truxima | Rituximab-Abbs | INJECTABLE;INJECTION | 761088 | CELLTRION INC | 02/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf#page=49 |
Turalio | Pexidartinib Hydrochloride | CAPSULE;ORAL | 211810 | DAIICHI SANKYO INC | 10/14/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf#page=20 |
Tussionex Pennkinetic | Chlorpheniramine Polistirex; Hydrocodone Polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 019111 | UCB INC | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf#page=25 |
Tuxarin ER | Chlorpheniramine Maleate; Codeine Phosphate | TABLET, EXTENDED RELEASE;ORAL | 206323 | MAINPOINTE | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf#page=28 |
Tuzistra XR | Chlorpheniramine Polistirex; Codeine Polistirex | SUSPENSION, EXTENDED RELEASE;ORAL | 207768 | AYTU | 06/28/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf#page=27 |
Tymlos | Abaloparatide | SOLUTION;SUBCUTANEOUS | 208743 | RADIUS HEALTH INC | 12/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s009lbl.pdf#page=18 |
Tysabri | Natalizumab | VIAL; SINGLE-USE | 125104 | BIOGEN IDEC | 04/11/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104s976s979lbl.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 | 04/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021856s015lbl.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 | 02/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021123s015lbl.pdf#page=46 |
Ultram | Tramadol Hydrochloride | TABLET;ORAL | 020281 | JANSSEN PHARMS | 02/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020281s040lbl.pdf#page=42 |
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 | 03/14/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf#page=20 |
Valtoco | Diazepam | SPRAY;NASAL | 211635 | NEURELIS INC | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211635s008lbl.pdf#page=24 |
Vanflyta | Quizartinib | TABLET;ORAL | 216993 | DAIICHI SANKYO | 07/20/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216993s000lbl.pdf#page=20 |
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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215429s001lbl.pdf#page=33 |
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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022104s023lbl.pdf#page=35 |
Veopoz | Pozelimab-Bbfg | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 761339 | REGENERON PHARMACEUTICALS | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761339s000lbl.pdf#page=16 |
Verquvo | Vericiguat | TABLET;ORAL | 214377 | Bayer AG | 05/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214377s002lbl.pdf#page=16 |
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 | 07/05/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022567s024lbl.pdf#page=17 |
Vimovo | Esomeprazole Magnesium; Naproxen | TABLET, DELAYED RELEASE;ORAL | 022511 | HORIZON | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022511s029lbl.pdf#page=40 |
Vimpat | Lacosamide | TABLET;ORAL | 022253 | UCB INC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf#page=30 |
Vimpat | Lacosamide | SOLUTION;INTRAVENOUS | 022254 | UCB INC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf#page=30 |
Vimpat | Lacosamide | SOLUTION;ORAL | 022255 | UCB INC | 09/30/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf#page=30 |
Viokace | Pancrelipase (Amylase;Lipase;Protease) | TABLET;ORAL | 022542 | VIOKACE | 09/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542s007lbl.pdf#page=12 |
Viramune | Nevirapine | SUSPENSION;ORAL | 020933 | BOEHRINGER INGELHEIM | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf#page=19 |
Viramune | Nevirapine | TABLET;ORAL | 020636 | BOEHRINGER INGELHEIM | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020636s052,020933s043lbl.pdf#page=19 |
Viramune XR | Nevirapine | TABLET, EXTENDED RELEASE;ORAL | 201152 | BOEHRINGER INGELHEIM | 06/10/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf#page=18 |
Visicol | Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | TABLET;ORAL | 021097 | SALIX PHARMS | 03/07/2013 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021097s016lbl.pdf#page=11 |
Vituz | Chlorpheniramine Maleate; Hydrocodone Bitartrate | SOLUTION;ORAL | 204307 | PERSION | 06/28/2018 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf#page=25 |
Vivactil | Protriptyline Hydrochloride | TABLET;ORAL | 016012 | TEVA WOMENS | 07/17/2014 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Vivactil.pdf |
Vivitrol | Naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897 | ALKERMES | 05/06/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021897s052lbl.pdf#page=33 |
Vivlodex | Meloxicam | CAPSULE;ORAL | 207233 | ZYLA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207233s004lbl.pdf#page=24 |
Vogelxo | Testosterone | GEL;TRANSDERMAL | 204399 | UPSHER SMITH LABS | 04/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf#page=23 |
Vogelxo | Testosterone | GEL, METERED;TRANSDERMAL | 204399 | UPSHER SMITH LABS | 04/30/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204399s012lbl.pdf#page=23 |
Voltaren | Diclofenac Sodium | TABLET, DELAYED RELEASE;ORAL | 019201 | NOVARTIS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019201s048lbl.pdf#page=18 |
Voltaren Arthritis Pain | Diclofenac Sodium | GEL;TOPICAL | 022122 | GLAXOSMITHKLINE CONS | 11/03/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf#page=22 |
Voltaren-XR | Diclofenac Sodium | TABLET, EXTENDED RELEASE;ORAL | 020254 | NOVARTIS | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf#page=18 |
Votrient | Pazopanib Hydrochloride | TABLET;ORAL | 022465 | NOVARTIS | 09/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022465s031s032lbl.pdf#page=27 |
Vraylar | Cariprazine Hydrochloride | CAPSULE;ORAL | 204370 | ALLERGAN | 05/24/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204370s006lbl.pdf#page=39 |
Vyvanse | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE;ORAL | 208510 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38 |
Vyvanse | Lisdexamfetamine Dimesylate | CAPSULE;ORAL | 021977 | TAKEDA PHARMS USA | 02/25/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf#page=38 |
Wegovy | Semaglutide | SOLUTION;SUBCUTANEOUS | 215256 | NOVO | 07/21/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf#page=34 |
Welireg | Belzutifan | TABLET;ORAL | 215383 | MERCK SHARP DOHME | 08/13/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf#page=14 |
Wellbutrin | Bupropion Hydrochloride | TABLET;ORAL | 018644 | GLAXOSMITHKLINE | 10/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018644s057lbl.pdf#page=32 |
Wellbutrin SR | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020358 | GLAXOSMITHKLINE | 10/20/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020358s064lbl.pdf#page=34 |
Wellbutrin XL | Bupropion Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021515 | BAUSCH | 03/04/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021515s044lbl.pdf#page=29 |
Xalkori | Crizotinib | CAPSULE;ORAL | 202570 | PF PRISM CV | 09/22/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s031lbl.pdf#page=35 |
Xanax | Alprazolam | TABLET;ORAL | 018276 | UPJOHN | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf#page=22 |
Xanax XR | Alprazolam | TABLET, EXTENDED RELEASE;ORAL | 021434 | UPJOHN | 01/13/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021434s022lbl.pdf#page=23 |
Xarelto | Rivaroxaban | TABLET;ORAL | 022406 | JANSSEN PHARMS | 03/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77 |
Xarelto | Rivaroxaban | TABLET;ORAL | 202439 | JANSSEN PHARMS | 03/01/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022406s039,202439s038lbl.pdf#page=77 |
Xarelto | Rivaroxaban | FOR SUSPENSION;ORAL | 215859 | JANSSEN PHARMS | 12/20/2021 | http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf#page=77 |
Xartemis XR | Acetaminophen; Oxycodone Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204031 | MALLINCKRODT INC | 09/18/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf#page=34 |
Xcopri | Cenobamate | TABLET;ORAL | 212839 | SK LIFE | 06/27/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212839s006s007lbl.pdf#page=25 |
Xeljanz | Tofacitinib Citrate | SOLUTION;ORAL | 213082 | PFIZER | 12/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66 |
Xeljanz | Tofacitinib Citrate | TABLET;ORAL | 203214 | PF PRISM CV | 12/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66 |
Xeljanz XR | Tofacitinib Citrate | TABLET, EXTENDED RELEASE;ORAL | 208246 | PFIZER | 12/14/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf#page=66 |
Xenazine | Tetrabenazine | TABLET;ORAL | 021894 | BAUSCH | 09/13/2017 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf#page=24 |
Xeomin | Incobotulinumtoxina | INJECTABLE;INJECTION | 125360 | MERZ PHARMS | 08/13/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125360s093lbl.pdf#page=23 |
Xiaflex | Collagenase Clostridium Histolyticum | SOLUTION; INJECTION | 125338 | AUXILIUM PHARMS | 07/12/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125338s111lbl.pdf#page=33 |
Xigduo XR | Dapagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649 | ASTRAZENECA AB | 10/13/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s018lbl.pdf#page=60 |
Xolair | Omalizumab | VIAL | 103976 | GENENTECH | 03/17/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103976s5243lbl.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 | 07/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf#page=42 |
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 | 04/04/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021196s042lbl.pdf#page=26 |
Xywav | Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate | SOLUTION;ORAL | 212690 | JAZZ | 04/04/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212690s011lbl.pdf#page=29 |
Yervoy | Ipilimumab | INJECTABLE; INJECTION | 125377 | BRISTOL MYERS SQUIBB | 02/15/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205103s009lbl.pdf#page=30 |
Yuflyma | Adalimumab-Aaty | INJECTABLE;SUBCUTANEOUS | 761219 | CELLTRION | 05/23/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf#page=39 |
Yusimry | Adalimumab-Aqvh | INJECTABLE;INJECTION | 761216 | COHERUS BIOSCIENCES INC | 03/31/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761216s003lbl.pdf#page=40 |
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 | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf#page=31 |
Zegerid | Omeprazole; Sodium Bicarbonate | FOR SUSPENSION;ORAL | 021636 | SALIX | 07/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf#page=31 |
Zelboraf | Vemurafenib | TABLET;ORAL | 202429 | HOFFMANN LA ROCHE | 05/18/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf#page=21 |
Zenpep | Pancrelipase;Lipase;Protease;Amylase | CAPSULE, DELAYED RELEASE;ORAL | 022210 | AIMMUNE | 09/28/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210s024lbl.pdf#page=14 |
Zenpep | Pancrelipase (Amylase;Lipase;Protease) | CAPSULE, DELAYED RELEASE;ORAL | 022210 | ZENPEP | 03/20/2020 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf |
Zeposia | Ozanimod Hydrochloride | CAPSULE;ORAL | 209899 | CELGENE INTL | 08/10/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.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 | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf#page=37 |
Zoloft | Sertraline Hydrochloride | TABLET;ORAL | 019839 | UPJOHN | 08/18/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf#page=37 |
Zolpidem Tartrate | Zolpidem Tartrate | TABLET;ORAL | 076062 | STRIDES PHARMA | 04/23/2007 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Zolpidem.pdf |
Zolpidem Tartrate Capsules | Zolpidem Tartrate | CAPSULE;ORAL | 215721 | Almatica Pharma | 05/09/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215721s000lbl.pdf#page=27 |
Zolpimist | Zolpidem Tartrate | SPRAY, METERED;ORAL | 022196 | AYTU | 08/18/2019 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022196s012lbl.pdf#page=19 |
Zonegran | Zonisamide | CAPSULE;ORAL | 020789 | CONCORDIA | 04/13/2020 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf#page=25 |
Zonisade | Zonisamide | SUSPENSION;ORAL | 214273 | AZURITY | 07/15/2022 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214273s000lbl.pdf#page=27 |
Zontivity | Vorapaxar Sulfate | TABLET;ORAL | 204886 | XSPIRE PHARMA | 11/07/2019 | http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf |
Zortress | Everolimus | TABLET;ORAL | 021560 | NOVARTIS | 08/10/2018 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf#page=32 |
Zorvolex | Diclofenac | CAPSULE;ORAL | 204592 | ZYLA | 04/28/2021 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204592s013lbl.pdf#page=26 |
Ztalmy | Ganaxolone | SUSPENSION;ORAL | 215904 | MARINUS PHARMACEUTICALS | 06/21/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215904s003s004lbl.pdf#page=16 |
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 |
Zynyz | Retifanlimab-Dlwr | INJECTABLE;INTRAVENOUS | 761334 | INCYTE | 03/22/2023 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761334s000lbl.pdf#page=18 |
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 |