Medication Guides

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

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Drug Name Active Ingredient Form;Route Appl. No. Company Date Link
Drug Name Active Ingredient Form;Route Appl. No. Company Date Link
Adderall 10 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 15 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall XR 20 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 SHIRE 07/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf#page=23
Adempas Riociguat TABLET;ORAL 204819 BAYER HLTHCARE 01/11/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf#page=24
Adzenys ER Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 204325 NEOS THERAPS INC 09/15/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204325s000lbl.pdf#page=26
Anaprox DS Naproxen Sodium TABLET;ORAL 018164 ATNAHS PHARMA US 03/10/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22
Aptiom Eslicarbazepine Acetate TABLET;ORAL 022416 SUNOVION PHARMS INC 09/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022416s009lbl.pdf#page=26
Atelvia Risedronate Sodium TABLET, DELAYED RELEASE;ORAL 022560 APIL 04/08/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf#page=23
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
Bavencio Avelumab INJECTABLE;INJECTION 761049 EMD SERONO INC 10/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf#page=23
Aciphex Sprinkle Rabeprazole Sodium CAPSULE, DELAYED RELEASE;ORAL 204736 CERECOR INC 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf#page=21
Actonel With Calcium (Copackaged) Calcium Carbonate; Risedronate Sodium TABLET, TABLET;ORAL 021823 WARNER CHILCOTT 04/08/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf#page=27
Actoplus MET Metformin Hydrochloride; Pioglitazone Hydrochloride TABLET;ORAL 021842 TAKEDA PHARMS USA 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021842s022lbl.pdf#page=41
Adderall XR 10 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 SHIRE 07/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf#page=23
Androgel Testosterone GEL, METERED;TRANSDERMAL 021015 ABBVIE 10/25/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188474.pdf
Androgel Testosterone GEL;TRANSDERMAL 021015 ABBVIE 10/25/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188474.pdf
Aplenzin Bupropion Hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108 VALEANT PHARMS NORTH 05/04/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022108s014lbl.pdf#page=28
Arcapta Neohaler Indacaterol Maleate POWDER;INHALATION 022383 SUNOVION PHARMS INC 02/25/2013 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000MedG.pdf
Arymo ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 208603 EGALET 10/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s001lbl.pdf#page=34
Benlysta Belimumab INJECTABLE; INJECTION 125370 HUMAN GENOME SCIENCES INC. 06/22/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062lbl.pdf#page=29
Abilify Aripiprazole SOLUTION;ORAL 021713 OTSUKA 02/23/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83
Absorica Isotretinoin CAPSULE;ORAL 021951 SUN PHARM INDS INC 08/31/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021951s014lbl.pdf#page=12
Aciphex Rabeprazole Sodium TABLET, DELAYED RELEASE;ORAL 020973 EISAI INC 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s039lbl.pdf#page=34
Adderall 5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Afrezza Insulin Recombinant Human POWDER;INHALATION 022472 MANNKIND 10/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf#page=12
Aranesp Darbepoetin Alfa VIAL; INTRAVENOUS 103951 AMGEN 10/31/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf#page=25
Banzel Rufinamide SUSPENSION;ORAL 201367 EISAI INC 10/06/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088564.pdf
Belsomra Suvorexant TABLET;ORAL 204569 MERCK SHARP DOHME 07/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204569s005lbl.pdf#page=22
Binosto Alendronate Sodium TABLET, EFFERVESCENT;ORAL 202344 MISSION PHARMA 12/30/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/BinostoMedGuide.pdf
Bydureon Exenatide Synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 ASTRAZENECA AB 04/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf#page=31
Actemra Tocilizumab INJECTABLE; INJECTION 125276 GENENTECH 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf#page=43
Actemra Tocilizumab INJECTABLE; INJECTION 125276 GENENTECH 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf#page=45
Actonel Risedronate Sodium TABLET;ORAL 020835 APIL 10/22/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf#page=38
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
Adderall 12.5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 30 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Amjevita Adalimumab-Atto INJECTABLE;INJECTION 761024 AMGEN INC 03/15/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524671.pdf
Ampyra Dalfampridine TABLET, EXTENDED RELEASE;ORAL 022250 ACORDA 09/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf#page=15
Anafranil Clomipramine Hydrochloride CAPSULE;ORAL 019906 SPECGX LLC 08/22/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019906s040lbl.pdf#page=27
Arymo ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 208603 EGALET 10/12/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf#page=32
Actemra Tocilizumab INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 125472 GENENTECH 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf#page=43
Actemra Tocilizumab INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 125472 GENENTECH 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf#page=45
Actiq Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747 CEPHALON 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020747s043s044lbl.pdf#page=21
Adasuve Loxapine POWDER;INHALATION 022549 GALEN UK 02/23/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf#page=26
Adderall 20 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adderall 7.5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate TABLET;ORAL 011522 TEVA WOMENS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf
Adlyxin Lixisenatide SOLUTION;SUBCUTANEOUS 208471 SANOFI-AVENTIS US 07/27/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf#page=31
Anoro Ellipta Umeclidinium Bromide; Vilanterol Trifenatate POWDER;INHALATION 203975 GLAXOSMITHKLINE 10/17/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf#page=27
Austedo Deutetrabenazine TABLET;ORAL 208082 TEVA BRANDED PHARM 06/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208082s000lbl.pdf#page=21
Avandia Rosiglitazone Maleate TABLET;ORAL 021071 SB PHARMCO 09/19/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf#page=39
Abilify Aripiprazole TABLET;ORAL 021436 OTSUKA 02/23/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83
Abstral Fentanyl Citrate TABLET;SUBLINGUAL 022510 SENTYNL THERAPS INC 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf#page=29
Adderall XR 15 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 SHIRE 07/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf#page=23
Adderall XR 5 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 SHIRE 07/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf#page=23
Ambien CR Zolpidem Tartrate TABLET, EXTENDED RELEASE;ORAL 021774 SANOFI AVENTIS US 09/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf#page=25
Arthrotec Diclofenac Sodium; Misoprostol TABLET, DELAYED RELEASE;ORAL 020607 GD SEARLE LLC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085919.pdf
Astagraf XL Tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096 ASTELLAS 12/16/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362199.pdf
Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 021277 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021085s064,021277s060lbl.pdf#page=31
Bavencio Avelumab INJECTABLE;INJECTION 761049 EMD SERONO INC 10/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf
Baxdela Delafloxacin Meglumine TABLET;ORAL 208610 MELINTA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf#page=23
Abilify Aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729 OTSUKA 02/23/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83
Abilify Aripiprazole INJECTABLE;INTRAMUSCULAR 021866 OTSUKA 02/23/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021436s042,021713s033,021729s025,021866s027lbl.pdf#page=83
Abilify Maintena Kit Aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 OTSUKA PHARM CO LTD 07/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202971s010lbl.pdf#page=56
Adderall XR 25 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 SHIRE 07/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf#page=23
Adderall XR 30 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303 SHIRE 07/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021303s029lbl.pdf#page=23
Addyi Flibanserin TABLET;ORAL 022526 SPROUT PHARMS 06/16/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM459254.pdf
Ambien Zolpidem Tartrate TABLET;ORAL 019908 SANOFI AVENTIS US 09/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019908s042lbl.pdf#page=22
Anaprox Naproxen Sodium TABLET;ORAL 018164 ATNAHS PHARMA US 03/10/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22
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 KEMPHARM 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208653s000lbl.pdf#page=35
Bevespi Aerosphere Formoterol Fumarate; Glycopyrrolate AEROSOL, METERED;INHALATION 208294 ASTRAZENECA PHARMS 04/25/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501636.pdf
Bevyxxa Betrixaban CAPSULE;ORAL 208383 PORTOLA PHARMS INC 07/14/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20
Botox Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf#page=38
Byetta Exenatide Synthetic INJECTABLE; SUBCUTANEOUS 021919 AMYLIN 10/30/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf
Cambia Diclofenac Potassium FOR SOLUTION;ORAL 022165 ASSERTIO 03/20/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM169077.pdf
Cellcept Mycophenolate Mofetil CAPSULE;ORAL 050722 ROCHE PALO 08/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cellcept Mycophenolate Mofetil SUSPENSION;ORAL 050759 ROCHE PALO 08/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Clenpiq Citric Acid; Magnesium Oxide; Sodium Picosulfate SOLUTION;ORAL 209589 FERRING PHARMS INC 11/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209589s000lbl.pdf#page=12
Cosentyx Secukinumab INJECTABLE;INJECTION 125504 NOVARTIS PHARMS CORP 06/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf#page=18
Darvocet-N 50 Acetaminophen; Propoxyphene Napsylate TABLET;ORAL 017122 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf
Accutane Isotretinoin CAPSULE;ORAL 018662 HOFFMANN LA ROCHE 10/22/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedGuide.pdf
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
Aranesp Darbepoetin Alfa VIAL; SUBCUTANEOUS 103951 AMGEN 10/31/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf#page=25
Aristada Aripiprazole LAuroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207533 ALKERMES INC 01/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207533s004lbl.pdf#page=35
Aveed Testosterone Undecanoate INJECTABLE;INTRAMUSCULAR 022219 ENDO PHARMS INC 09/01/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/AveedMedGuide.pdf
Avelox in Sodium Chloride 0.8% in Plastic Container Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 021277 BAYER HLTHCARE 10/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021085s061s062,021277s057s058lbl.pdf#page=33
Baxdela Delafloxacin Meglumine TABLET;ORAL 208610 MELINTA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf#page=24
Belbuca Buprenorphine Hydrochloride FILM;BUCCAL 207932 BDSI 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207932s002lbl.pdf#page=28
Betaseron Interferon Beta-1b VIAL; SUBCUTANEOUS 103471 BAYER HEALTHCARE PHARMS 08/31/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103471s5193lbl.pdf#page=18
Blincyto Blinatumomab INJECTABLE;INJECTION 125557 AMGEN 04/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf#page=33
Arymo ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 208603 EGALET 10/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf#page=32
Ativan Lorazepam TABLET;ORAL 017794 VALEANT INTL 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf#page=9
Banzel Rufinamide TABLET;ORAL 021911 EISAI INC 06/17/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf#page=18
Bavencio Avelumab INJECTABLE;INTRAVENOUS 761078 EMD SERONO INC 05/09/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf#page=23
Baxdela Delafloxacin Meglumine POWDER;INTRAVENOUS 208611 MELINTA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208610s005,208611s004lbl.pdf#page=23
Boniva Ibandronate Sodium TABLET;ORAL 021455 HOFFMANN LA ROCHE 12/07/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf#page=19
Boniva Ibandronate Sodium INJECTABLE;INTRAVENOUS 021858 ROCHE 12/07/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf#page=18
Briviact Brivaracetam SOLUTION;INTRAVENOUS 205837 UCB INC 05/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17
Brovana Arformoterol Tartrate SOLUTION;INHALATION 021912 SUNOVION 12/12/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf#page=22
Bydureon Bcise Exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210 ASTRAZENECA AB 10/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209210s000lbl.pdf#page=23
Binosto Alendronate Sodium TABLET, EFFERVESCENT;ORAL 202344 MISSION PHARMA 12/30/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202344s008lbl.pdf#page=33
Brilinta Ticagrelor TABLET;ORAL 022433 ASTRAZENECA PHARMS 03/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022433s022lbl.pdf#page=25
Briviact Brivaracetam TABLET;ORAL 205836 UCB INC 05/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17
Bunavail Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL 205637 BDSI 10/31/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205637s016lbl.pdf#page=33
Cambia Diclofenac Potassium FOR SOLUTION;ORAL 022165 ASSERTIO 03/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf#page=19
Caprelsa Vandetanib TABLET;ORAL 022405 GENZYME CORP 10/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022405s014lbl.pdf#page=20
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 10/18/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf
Conzip Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022370 CIPHER PHARMS INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022370s016s017lbl.pdf#page=34
Demerol Meperidine Hydrochloride SYRUP;ORAL 005010 US PHARM HOLDINGS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30
Dexilant Dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 022287 TAKEDA PHARMS USA 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022287s029s030lbl.pdf#page=24
Briviact Brivaracetam SOLUTION;ORAL 205838 UCB INC 05/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205836s005,205837s004,205838s003lbl.pdf#page=17
Celebrex Celecoxib CAPSULE;ORAL 020998 GD SEARLE 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020998s050lbl.pdf#page=21
Celexa Citalopram Hydrobromide SOLUTION;ORAL 021046 FOREST LABS 12/03/2012 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088568.pdf
Celontin Methsuximide CAPSULE;ORAL 010596 PARKE DAVIS 06/15/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf
Cipro Ciprofloxacin INJECTABLE;INJECTION 019847 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019847s059lbl.pdf#page=32
Cipro Ciprofloxacin FOR SUSPENSION;ORAL 020780 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019537s088,020780s045lbl.pdf#page=39
Cipro in Dextrose 5% in Plastic Container Ciprofloxacin INJECTABLE;INJECTION 019857 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019857s066lbl.pdf#page=33
Codeine Sulfate Codeine Sulfate SOLUTION;ORAL 202245 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202245s006s007lbl.pdf#page=27
Colcrys Colchicine TABLET;ORAL 022352 TAKEDA PHARMS USA 12/22/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf#page=24
Cordarone Amiodarone Hydrochloride TABLET;ORAL 018972 WYETH PHARMS 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.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
Aubagio Teriflunomide TABLET;ORAL 202992 SANOFI AVENTIS US 12/19/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202992s003lbl.pdf#page=25
Avandamet Metformin Hydrochloride; Rosiglitazone Maleate TABLET;ORAL 021410 SB PHARMCO 04/05/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021410s040lbl.pdf#page=38
Avandaryl Glimepiride; Rosiglitazone Maleate TABLET;ORAL 021700 SB PHARMCO 12/16/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf#page=39
Avelox Moxifloxacin Hydrochloride TABLET;ORAL 021085 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021085s064,021277s060lbl.pdf#page=31
Avonex Interferon Beta-1a VIAL 103628 BIOGEN 12/22/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103628s5258lbl.pdf#page=21
Baxdela Delafloxacin Meglumine POWDER;INTRAVENOUS 208611 MELINTA 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf#page=24
Celexa Citalopram Hydrobromide TABLET;ORAL 020822 ALLERGAN SALES LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf#page=33
Cerdelga Eliglustat Tartrate CAPSULE;ORAL 205494 GENZYME CORP 08/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494s003lbl.pdf#page=19
Chlordiazepoxide and Amitriptyline Hydrochloride Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 071297 MYLAN PHARMS INC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/071297Orig1s026MG.pdf
Cipro XR Ciprofloxacin; Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021473s038lbl.pdf#page=27
Caprelsa Vandetanib TABLET;ORAL 022405 GENZYME CORP 10/12/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250399.pdf
Carbatrol Carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712 SHIRE 08/26/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf
Cataflam Diclofenac Potassium TABLET;ORAL 020142 NOVARTIS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135935.pdf
Cellcept Mycophenolate Mofetil TABLET;ORAL 050723 ROCHE PALO 08/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cellcept Mycophenolate Mofetil Hydrochloride INJECTABLE;INJECTION 050758 ROCHE PALO 08/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050722s035,050723s035,050758s033,050759s041lbl.pdf#page=39
Cimzia Certolizumab Pegol INJECTABLE; INJECTION 125160 UCB INC 06/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf#page=37
Codeine Sulfate Codeine Sulfate TABLET;ORAL 022402 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf#page=26
Conzip Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022370 CIPHER PHARMS INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022370s015lbl.pdf#page=33
Creon Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 020725 ABBVIE 06/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf#page=16
Dalmane Flurazepam Hydrochloride CAPSULE;ORAL 016721 VALEANT PHARM INTL 03/27/2009 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016721s077lbl.pdf
Dolophine Hydrochloride Methadone Hydrochloride SYRUP;ORAL 006134 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf#page=33
Doral Quazepam TABLET;ORAL 018708 GALT PHARMS 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf#page=12
Dotarem Gadoterate Meglumine SOLUTION;INTRAVENOUS 204781 GUERBET 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s009lbl.pdf#page=29
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
Duragesic-100 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48
Duragesic-50 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48
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
Enbrel Etanercept VIAL; SUBCUTANEOUS 103795 IMMUNEX 10/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34
Estazolam Estazolam TABLET;ORAL 074921 MAYNE PHARMA 12/16/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM359235.pdf
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf#page=32
Felbatol Felbamate TABLET;ORAL 020189 MYLAN SPECIALITY LP 08/31/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf
Avelox Moxifloxacin Hydrochloride TABLET;ORAL 021085 BAYER HLTHCARE 10/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021085s061s062,021277s057s058lbl.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
Butrans Buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 PURDUE PHARMA LP 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021306s027lbl.pdf#page=40
Byetta Exenatide Synthetic INJECTABLE;SUBCUTANEOUS 021773 ASTRAZENECA AB 02/25/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf
Celebrex Celecoxib CAPSULE;ORAL 021156 GD SEARLE LLC 02/04/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003MedG.pdf
Cipro Ciprofloxacin Hydrochloride TABLET;ORAL 019537 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019537s088,020780s045lbl.pdf#page=39
Clinoril Sulindac TABLET;ORAL 017911 MERCK 12/23/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf
Combunox Ibuprofen; Oxycodone Hydrochloride TABLET;ORAL 021378 FOREST LABS 09/02/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088574.pdf
Cotempla XR-Odt Methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NEOS THERAPS INC 06/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf#page=21
Cymbalta Duloxetine Hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021427 LILLY 12/19/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf#page=32
Desoxyn Methamphetamine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378 RECORDATI RARE 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf#page=13
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
Duragesic-37 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48
Dysport Abobotulinumtoxina INJECTABLE; INJECTION 125274 IPSEN BIOPHARM LTD 11/05/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125274s109lbl.pdf#page=30
Effexor XR Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020699 WYETH PHARMS 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s110s111lbl.pdf#page=36
Eovist Gadoxetate Disodium SOLUTION;INTRAVENOUS 022090 BAYER HLTHCARE 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf#page=51
Epzicom Abacavir Sulfate; LAmivudine TABLET;ORAL 021652 VIIV HLTHCARE 04/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021652s023lbl.pdf#page=28
Factive Gemifloxacin Mesylate TABLET;ORAL 021158 LG CHEM LTD 10/18/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152723.pdf
Felbatol Felbamate SUSPENSION;ORAL 020189 MYLAN SPECIALITY LP 08/31/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027mg.pdf
Fioricet W/ Codeine Acetaminophen; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 020232 ACTAVIS LABS UT INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf#page=39
Colcrys Colchicine TABLET; ORAL 022353 AR HOLDING CO INC 10/16/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf
Contrave Bupropion Hydrochloride; Naltrexone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063 NALPROPION 06/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200063s013lbl.pdf#page=39
Copegus Ribavirin TABLET;ORAL 021511 ROCHE 08/11/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021511s029lbl.pdf#page=27
Cyltezo Adalimumab-Adbm INJECTABLE;INJECTION 761058 BOEHRINGER INGELHEIM 08/25/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf#page=30
Depakene Valproic Acid CAPSULE;ORAL 018081 ABBVIE 03/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018081Orig1s068%20018082Orig1s051lbl.pdf#page=38
Dilantin Phenytoin Sodium CAPSULE;ORAL 084349 PARKE-DAVIS 12/22/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084349s081s082s084lbl.pdf#page=19
Dilantin Phenytoin TABLET, CHEWABLE;ORAL 084427 PFIZER 12/22/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/084427s039s041lbl.pdf#page=17
Duragesic-100 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51
Duragesic-12 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48
Duragesic-50 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51
Bydureon Pen Exenatide Synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200 ASTRAZENECA AB 04/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf#page=31
Cerdelga Eliglustat Tartrate CAPSULE;ORAL 205494 GENZYME CORP 08/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205494Orig1s000lbl.pdf
Chantix Varenicline Tartrate TABLET;ORAL 021928 PF PRISM CV 06/01/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021928s045_046lbl.pdf#page=22
Cipro XR Ciprofloxacin; Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021473 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 021473s039lbl.pdf#page=27
Codeine Sulfate Codeine Sulfate TABLET;ORAL 022402 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf#page=26
Concerta Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 JANSSEN PHARMS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf#page=30
Cordarone Amiodarone Hydrochloride TABLET;ORAL 018972 WYETH PHARMS 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf#page=13
Corlanor Ivabradine Hydrochloride TABLET;ORAL 206143 AMGEN INC 01/10/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206143Orig1s002lbl.pdf#page=20
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
Darvocet-N 100 Acetaminophen; Propoxyphene Napsylate TABLET;ORAL 017122 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187067.pdf
Duragesic-75 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51
Dysport Abobotulinumtoxina INJECTABLE; INJECTION 125274 IPSEN BIOPHARM LTD 11/05/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125274s112lbl.pdf#page=30
EC-Naprosyn Naproxen TABLET, DELAYED RELEASE;ORAL 020067 ATNAHS PHARMA US 03/10/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22
Effient Prasugrel Hydrochloride TABLET;ORAL 022307 ELI LILLY AND CO 03/09/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM238428.pdf
Elidel Pimecrolimus CREAM;TOPICAL 021302 VALEANT BERMUDA 06/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088587.pdf
Enbrel Etanercept SYRINGE 103795 IMMUNEX 10/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 103795s5569lbl.pdf#page=34
Epogen/Procrit Epoetin Alfa VIAL; MULTIDOSE 103234 AMGEN 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27
Evista Raloxifene Hydrochloride TABLET; ORAL 022042 LILLY 09/13/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
Exalgo Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217 SPECGX LLC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004mg.pdf
Ferriprox Deferiprone TABLET;ORAL 021825 APOPHARMA INC 02/24/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf#page=8
Fortesta Testosterone GEL, METERED;TRANSDERMAL 021463 ENDO PHARMS 10/25/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM239932.pdf
Focalin XR Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NOVARTIS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf#page=17
Foradil Formoterol Fumarate POWDER;INHALATION 020831 NOVARTIS 03/02/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088602.pdf
Forteo Teriparatide Recombinant Human INJECTABLE;SUBCUTANEOUS 021318 LILLY 04/28/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088604.pdf
Fosamax Plus D Alendronate Sodium; Cholecalciferol TABLET;ORAL 021762 MERCK 11/30/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241521.pdf
H.P. Acthar Gel Repository Corticotropin INJECTABLE; INJECTION 022432 QUESTCOR PHARMA 10/15/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf
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
Hycodan Homatropine METhylbromide; Hydrocodone Bitartrate SYRUP;ORAL 005213 GENUS LIFESCIENCES 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27
Hysingla Hydrocodone Bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 PURDUE PHARMA LP 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf#page=36
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
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 03/15/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf
Botox Cosmetic Onabotulinumtoxina VIAL; SINGLE-USE 103000 ALLERGAN 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103000s5307lbl.pdf#page=38
Braftovi Encorafenib CAPSULE;ORAL 210496 ARRAY BIOPHARMA INC 06/27/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf#page=17
Brisdelle Paroxetine Mesylate CAPSULE;ORAL 204516 SEBELA IRELAND LTD 04/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204516s005lbl.pdf#page=22
Butrans Buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 PURDUE PHARMA LP 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021306s032s034lbl.pdf#page=40
Cassipa Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;SUBLINGUAL 208042 TEVA PHARMS USA 09/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208042s000lbl.pdf#page=34
Cipro Ciprofloxacin Hydrochloride TABLET;ORAL 019537 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf#page=41
Cipro Ciprofloxacin FOR SUSPENSION;ORAL 020780 BAYER HLTHCARE 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf#page=41
Codeine Sulfate Codeine Sulfate SOLUTION;ORAL 202245 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202245s005lbl.pdf#page=26
Demerol Meperidine Hydrochloride INJECTABLE;INJECTION 005010 US PHARM HOLDINGS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30
Demerol Meperidine Hydrochloride TABLET;ORAL 005010 US PHARM HOLDINGS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005010s056s057lbl.pdf#page=30
Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204150 ALEMBIC PHARMS LTD 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204150s007lbl.pdf#page=30
Dextroamphetamine Sulfate Dextroamphetamine Sulfate SOLUTION;ORAL 040776 OUTLOOK PHARMS 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088583.pdf
Duexis Famotidine; Ibuprofen TABLET;ORAL 022519 HORIZON 06/07/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022519s011lbl.pdf#page=22
Duragesic-25 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48
Evista Raloxifene Hydrochloride TABLET;ORAL 020815 LILLY 06/27/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
Exubera Insulin Recombinant Human POWDER;INHALATION 021868 PFIZER 09/29/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088594.pdf
Feldene Piroxicam CAPSULE;ORAL 018147 PFIZER 05/09/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf#page=16
Fentanyl Citrate Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907 SPECGX LLC 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078907MedGuide.pdf
Flector Diclofenac Epolamine PATCH;TOPICAL 021234 INST BIOCHEM 08/30/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021234s015lbl.pdf#page=21
Forfivo XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 ALVOGEN 05/04/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022497s004lbl.pdf#page=32
Fosrenol Lanthanum Carbonate TABLET, CHEWABLE;ORAL 021468 SHIRE LLC 11/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf#page=12
Daliresp Roflumilast TABLET;ORAL 022522 ASTRAZENECA PHARMS 01/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022522s009lbl.pdf#page=17
Darvon-N Propoxyphene Napsylate TABLET;ORAL 016862 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf
Depakene Valproic Acid SYRUP;ORAL 018082 ABBVIE 03/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018081Orig1s068%20018082Orig1s051lbl.pdf#page=38
Desoxyn Methamphetamine Hydrochloride TABLET;ORAL 005378 RECORDATI RARE 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf#page=13
Desyrel Trazodone Hydrochloride TABLET;ORAL 018207 PRAGMA PHARMS LLC 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf#page=14
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-30 Phenytoin SUSPENSION;ORAL 008762 PARKE DAVIS 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18
Embeda Morphine Sulfate; Naltrexone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 ALPHARMA PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022321s028s029lbl.pdf#page=28
Equetro Carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710 VALIDUS PHARMS 09/23/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf#page=22
Esomeprazole Strontium Esomeprazole Strontium CAPSULE, DELAYED RELEASE;ORAL 202342 R2 PHARMA LLC 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202342s005lbl.pdf#page=29
Extraneal Icodextrin SOLUTION;INTRAPERITONEAL 021321 BAXTER HLTHCARE 12/16/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135933.pdf
Farxiga Dapagliflozin TABLET;ORAL 202293 ASTRAZENECA AB 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf#page=29
Farydak Panobinostat LActate CAPSULE;ORAL 205353 NOVARTIS PHARMS CORP 06/06/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM436377.pdf
Fentanyl Citrate Fentanyl Citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312 PAR PHARM 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf
Fiorinal W/Codeine Aspirin; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 019429 ALLERGAN SALES LLC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019429s041s042lbl.pdf#page=42
Fosamax Alendronate Sodium TABLET;ORAL 020560 MERCK AND CO INC 11/30/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24
Fosamax Alendronate Sodium SOLUTION;ORAL 021575 MERCK 11/30/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf#page=24
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf#page=32
Gralise Gabapentin TABLET;ORAL 022544 ASSERTIO 03/06/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM245196.pdf
Hemlibra Emicizumab INJECTABLE;INJECTION 761083 GENENTECH INC 10/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf#page=21
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 12/22/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352352.pdf
Desyrel Trazodone Hydrochloride TABLET;ORAL 018207 PRAGMA PHARMS LLC 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf#page=13
Duragesic-37 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51
Duragesic-75 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s072s073lbl.pdf#page=48
Embeda Morphine Sulfate; Naltrexone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321 ALPHARMA PHARMS 09/18/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM179172.pdf
Enbrel Etanercept VIAL; SUBCUTANEOUS 103795 IMMUNEX 10/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34
Entyvio Vedolizumab INJECTABLE;INJECTION 125476 TAKEDA PHARMS USA 02/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125476s022lbl.pdf#page=20
Factive Gemifloxacin Mesylate TABLET;ORAL 021158 LG CHEM LTD 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021158s025lbl.pdf#page=11
Ferriprox Deferiprone SOLUTION;ORAL 208030 APOPHARMA INC 04/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf#page=11
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
Fosamax Plus D Alendronate Sodium; Cholecalciferol TABLET;ORAL 021762 MERCK 11/30/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021762s020lbl.pdf#page=22
Fycompa Perampanel SUSPENSION;ORAL 208277 EISAI INC 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24
Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf#page=31
Humira Adalimumab SYRINGE 125057 ABBVIE INC 10/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53
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
Invirase Saquinavir Mesylate TABLET;ORAL 021785 HOFFMANN-LA ROCHE 03/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf#page=25
Juxtapid Lomitapide Mesylate CAPSULE;ORAL 203858 AEGERION 06/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf#page=32
Ketek Telithromycin TABLET;ORAL 021144 SANOFI AVENTIS US 11/04/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088615.pdf
Kevzara Sarilumab INJECTABLE;INJECTION 761037 SANOFI SYNTHELABO 04/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf#page=27
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s046lbl.pdf#page=54
Lamictal Lamotrigine TABLET;ORAL 020241 GLAXOSMITHKLINE LLC 07/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64
Imfinzi Durvalumab INJECTABLE;INJECTION 761069 ASTRAZENECA UK LTD 02/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf#page=24
Intermezzo Zolpidem Tartrate TABLET;SUBLINGUAL 022328 PURDUE PHARMA 11/13/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM281854.pdf
Invirase Saquinavir Mesylate CAPSULE;ORAL 020628 HOFFMANN LA ROCHE 03/15/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf
Kalbitor Ecallantide INJECTABLE; INJECTION 125277 DYAX CORP. 09/08/2014 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125277MedGuide.pdf
Kazano Alogliptin Benzoate; METformin Hydrochloride TABLET;ORAL 203414 TAKEDA PHARMS USA 02/15/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203414s007lbl.pdf#page=32
Ketek Telithromycin TABLET;ORAL 021144 SANOFI AVENTIS US 11/04/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf#page=29
Korlym Mifepristone TABLET;ORAL 202107 CORCEPT THERAP 05/16/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf#page=19
Lacosamide Lacosamide SOLUTION;ORAL 204839 AMNEAL PHARMS 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LacosamideTabletsCVMedGuide.pdf
Lamictal CD Lamotrigine TABLET, CHEWABLE;ORAL 020764 GLAXOSMITHKLINE LLC 07/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64
Levaquin Levofloxacin INJECTABLE;INJECTION 020635 JANSSEN PHARMS 02/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
Librax Chlordiazepoxide Hydrochloride; Clidinium Bromide CAPSULE;ORAL 012750 VALEANT PHARMS 01/13/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012750s065lbl.pdf#page=8
Fycompa Perampanel TABLET;ORAL 202834 EISAI INC 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf#page=24
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 03/21/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333533.pdf
Halcion Triazolam TABLET;ORAL 017892 PHARMACIA AND UPJOHN 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017892s049lbl.pdf#page=13
Humira Adalimumab VIAL 125057 ABBVIE INC 10/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125057s403lbl.pdf#page=53
Ilaris Canakinumab INJECTABLE; SUBCUTANEOUS 125319 NOVARTIS PHARMS 12/22/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf#page=20
Indocin Indomethacin SUSPENSION;ORAL 018332 IROKO PHARMS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088612.pdf
Indocin SR Indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185 IROKO PHARMS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501640.pdf
Invokamet Canagliflozin; METformin Hydrochloride TABLET;ORAL 204353 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf#page=53
Invokamet XR Canagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf#page=57
Jornay PM Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311 IRONSHORE PHARMS 08/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf#page=19
Keytruda Pembrolizumab POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER 125514 MERCK SHARP DOHME 11/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 125514s041lbl.pdf#page=56
Iclusig Ponatinib Hydrochloride TABLET;ORAL 203469 ARIAD 10/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf#page=24
Jynarque Tolvaptan TABLET;ORAL 204441 OTSUKA PHARM CO LTD 07/30/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf#page=18
Kaletra Lopinavir; Ritonavir CAPSULE;ORAL 021226 ABBVIE 06/15/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021226s045lbl.pdf#page=50
Kaletra Lopinavir; Ritonavir SOLUTION;ORAL 021251 ABBVIE 10/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51
Klonopin Clonazepam TABLET;ORAL 017533 ROCHE 10/25/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf#page=19
Krystexxa Pegloticase INJECTABLE; INJECTION 125293 HORIZON PHARMA 07/13/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227568.pdf
Lacosamide Lacosamide TABLET;ORAL 204857 AMNEAL PHARMS NY 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE ORAL SOLUTIONMed Guide.pdf
Levaquin Levofloxacin SOLUTION;ORAL 021721 JANSSEN PHARMS 02/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
Lexapro Escitalopram Oxalate SOLUTION;ORAL 021365 ALLERGAN SALES LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24
Lupron Depot-Ped Leuprolide Acetate INJECTABLE;INJECTION 020263 ABBVIE ENDOCRINE INC 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020263s042lbl.pdf#page=20
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 09/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf#page=23
Darvon Propoxyphene Hydrochloride CAPSULE;ORAL 010997 XANODYNE PHARM 09/25/2009 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187068.pdf
Daypro Oxaprozin TABLET;ORAL 018841 GD SEARLE 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501638.pdf
Daytrana Methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NOVEN PHARMS INC 11/06/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021514s028lbl.pdf#page=23
Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE;ORAL 021168 ABBVIE 03/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021168s038lbl.pdf#page=44
Dexedrine Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 017078 IMPAX LABS INC 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf#page=9
Dilantin-125 Phenytoin SUSPENSION;ORAL 008762 PARKE DAVIS 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008762s060s061lbl.pdf#page=18
Dolophine Hydrochloride Methadone Hydrochloride TABLET;ORAL 006134 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s046s048lbl.pdf#page=33
Dotarem Gadoterate Meglumine SOLUTION;INTRAVENOUS 204781 GUERBET 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204781s008lbl.pdf#page=29
Duragesic-12 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51
Duragesic-25 Fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019813s075s076lbl.pdf#page=51
Daypro Alta Oxaprozin Potassium TABLET;ORAL 020776 GD SEARLE 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088580.pdf
Depakote Divalproex Sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680 ABBVIE 03/06/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019680s047lbl.pdf#page=39
Desvenlafaxine Desvenlafaxine Fumarate TABLET, EXTENDED RELEASE;ORAL 205208 TEVA PHARMS USA 07/18/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372058.pdf
Desvenlafaxine Desvenlafaxine Fumarate TABLET, EXTENDED RELEASE;ORAL 205583 SUN PHARMA GLOBAL 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205583s006lbl.pdf#page=30
Dilaudid Hydromorphone Hydrochloride TABLET;ORAL 019892 RHODES PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf#page=27
Droxia Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 12/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf#page=15
Dyanavel XR Amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147 TRIS PHARMA INC 10/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208147s003lbl.pdf#page=15
Edluar Zolpidem Tartrate TABLET;SUBLINGUAL 021997 MYLAN SPECIALITY LP 10/24/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135937.pdf
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
Eliquis Apixaban TABLET;ORAL 202155 BRISTOL MYERS SQUIBB 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202155s020lbl.pdf#page=40
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE; ORAL 022509 SMITHKLINE BEECHAM 01/29/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm254322.pdf
Lexapro Escitalopram Oxalate TABLET;ORAL 021323 ALLERGAN SALES LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf#page=24
Lithium Carbonate Lithium Carbonate TABLET;ORAL 018558 WEST-WARD PHARMS INT 10/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19
Lupron Leuprolide Acetate INJECTABLE;INJECTION 019010 ABBVIE ENDOCRINE INC 07/11/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019010s038lbl.pdf#page=27
Lynparza Olaparib CAPSULE;ORAL 206162 ASTRAZENECA PHARMS 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf#page=16
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 022195 WEST-WARD PHARMS INT 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022195s011lbl.pdf#page=26
Naprelan Naproxen Sodium TABLET, EXTENDED RELEASE;ORAL 020353 ALVOGEN MALTA 09/06/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280324.pdf
Neurontin Gabapentin CAPSULE;ORAL 020235 PFIZER PHARMS 10/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32
Neurontin Gabapentin SOLUTION;ORAL 021129 PARKE DAVIS 10/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32
Noctiva Desmopressin Acetate SPRAY, METERED;NASAL 201656 AVADEL SPECLT 03/03/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf#page=13
Invokamet Canagliflozin; METformin Hydrochloride TABLET;ORAL 204353 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf#page=57
Janumet XR Metformin Hydrochloride; Sitagliptin Phosphate TABLET, EXTENDED RELEASE;ORAL 202270 MERCK SHARP DOHME 02/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf#page=32
Januvia Sitagliptin Phosphate TABLET;ORAL 021995 MERCK SHARP DOHME 02/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf#page=24
Juvisync Simvastatin; Sitagliptin Phosphate TABLET;ORAL 202343 MERCK SHARP DOHME 02/24/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM275945.pdf
Kadian Morphine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616 ALLERGAN SALES LLC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020616s057lbl.pdf#page=33
Klonopin Rapidly Disintegrating Clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 020813 ROCHE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s058lbl.pdf#page=20
Lamisil Terbinafine Hydrochloride GRANULE;ORAL 022071 NOVARTIS 01/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020539s029,022071s013lbl.pdf#page=10
Lithium Carbonate Lithium Carbonate CAPSULE;ORAL 017812 WEST-WARD PHARMS INT 10/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19
Lynparza Olaparib TABLET;ORAL 208558 ASTRAZENECA PHARMS 09/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s005lbl.pdf#page=27
Lyrica Pregabalin SOLUTION;ORAL 022488 PF PRISM CV 05/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54
Kombiglyze XR Metformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 ASTRAZENECA AB 02/27/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280360.pdf
Krystexxa Pegloticase INJECTABLE; INJECTION 125293 HORIZON PHARMA 07/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf#page=14
Kynamro Mipomersen Sodium SOLUTION;SUBCUTANEOUS 203568 KASTLE THERAPS LLC 10/25/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337730.pdf
Lamictal ODT Lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251 GLAXOSMITHKLINE LLC 07/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s056,020764s049,022251s020lbl.pdf#page=64
Latuda Lurasidone Hydrochloride TABLET;ORAL 200603 SUNOVION PHARMS INC 03/05/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200603s029lbl.pdf#page=66
Lazanda Fentanyl Citrate SPRAY, METERED;NASAL 022569 ELEFSEE PHARMS INTL 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022569s024lbl.pdf#page=35
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf#page=51
Lindane Lindane SHAMPOO;TOPICAL 087266 OLTA PHARMS 04/05/2004 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneLotionMedGuide.pdf
Lotronex Alosetron Hydrochloride TABLET;ORAL 021107 SEBELA IRELAND LTD 01/07/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088624.pdf
Methylin Methylphenidate Hydrochloride TABLET, CHEWABLE;ORAL 021475 SPECGX LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021475s010lbl.pdf#page=13
Limbitrol DS Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 016949 HERITAGE PHARMS INC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf#page=12
Lindane Lindane LOTION;TOPICAL 087313 OLTA PHARMS 09/04/2001 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneShampooMedGuide.pdf
Marplan Isocarboxazid TABLET;ORAL 011961 VALIDUS PHARMS INC 11/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011961s045lbl.pdf#page=16
Mifeprex Mifepristone TABLET;ORAL 020687 DANCO LABS LLC 08/05/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 201517 LANNETT CO INC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf#page=26
Motrin Ibuprofen TABLET;ORAL 017463 MCNEIL CONSUMER 09/10/2007 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088647.pdf
Movantik Naloxegol Oxalate TABLET;ORAL 204760 ASTRAZENECA PHARMS 02/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf#page=16
Multaq Dronedarone Hydrochloride TABLET;ORAL 022425 SANOFI AVENTIS US 02/12/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf#page=22
Multihance Gadobenate Dimeglumine INJECTABLE;INTRAVENOUS 021357 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021357s014,021358s013lbl.pdf#page=34
Myfortic Mycophenolic Acid TABLET, DELAYED RELEASE;ORAL 050791 NOVARTIS 12/23/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172735.pdf
Nesina Alogliptin Benzoate TABLET;ORAL 022271 TAKEDA PHARMS USA 12/12/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337732.pdf
Fiorinal W/Codeine Aspirin; Butalbital; Caffeine; Codeine Phosphate CAPSULE;ORAL 019429 ALLERGAN SALES LLC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019429s040lbl.pdf#page=36
Fosamax Alendronate Sodium TABLET;ORAL 020560 MERCK AND CO INC 11/30/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf
Fosamax Alendronate Sodium SOLUTION;ORAL 021575 MERCK 11/30/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241519.pdf
Fosrenol Lanthanum Carbonate POWDER;ORAL 204734 SHIRE DEV LLC 11/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf#page=12
Golytely Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous FOR SOLUTION;ORAL 019011 BRAINTREE 05/06/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370635.pdf
Inflectra Infliximab-Dyyb INJECTABLE;INJECTION 125544 CELLTRION INC 07/27/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM497384.pdf
Intron A Interferon Alfa-2b VIAL 103132 SCHERING 05/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103132s5196lbl.pdf#page=40
Janumet Metformin Hydrochloride; Sitagliptin Phosphate TABLET;ORAL 022044 MERCK SHARP DOHME 02/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022044s043lbl.pdf#page=32
Jentadueto Linagliptin; METformin Hydrochloride TABLET;ORAL 201281 BOEHRINGER INGELHEIM 08/10/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf#page=20
Kadian Morphine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616 ALLERGAN SALES LLC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020616s061s062lbl.pdf#page=34
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 SYRINGE 103795 IMMUNEX 10/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103795s5563s5564lbl.pdf#page=34
Epidiolex Cannabidiol SOLUTION; ORAL 210365 GW RESEARCH LTD 06/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf#page=23
Epogen/Procrit Epoetin Alfa VIAL; SINGLE-USE 103234 AMGEN 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf#page=27
Erivedge Vismodegib CAPSULE;ORAL 203388 GENENTECH 08/01/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf#page=12
Exalgo Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217 SPECGX LLC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021217s023s024lbl.pdf#page=30
Extavia Interferon Beta-1b INJECTABLE; SUBCUTANEOUS 125290 NOVARTIS PHARMS 05/12/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125290s062lbl.pdf#page=16
Fetzima Levomilnacipran Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 ALLERGAN SALES LLC 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204168s005lbl.pdf#page=27
Fycompa Perampanel TABLET;ORAL 202834 EISAI INC 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24
Gadavist Gadobutrol SOLUTION;INTRAVENOUS 201277 BAYER HLTHCARE 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022090s015,201277s015lbl.pdf#page=51
Lyrica Pregabalin CAPSULE;ORAL 021446 PF PRISM CV 05/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021446s032,022488s011lbl.pdf#page=50
Magnevist Gadopentetate Dimeglumine INJECTABLE;INJECTION 021037 BAYER HLTHCARE 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf#page=13
Metadate CD Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259 LANNETT CO INC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021259s030lbl.pdf#page=20
Mitigare Colchicine CAPSULE;ORAL 204820 HIKMA INTL PHARMS 09/26/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM417495.pdf
Moviprep Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 021881 SALIX PHARMS 12/17/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM253840.pdf
Nalfon Fenoprofen Calcium CAPSULE;ORAL 017604 XSPIRE PHARMA 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf
Naprosyn Naproxen SUSPENSION;ORAL 018965 ATNAHS PHARMA US 03/10/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018965s025lbl.pdf#page=21
Nulytely-Flavored Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION;ORAL 019797 BRAINTREE 09/23/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf
Omniscan Gadodiamide INJECTABLE;INJECTION 022066 GE HEALTHCARE 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf#page=1
Opana ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655 ENDO PHARMS 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201655s021lbl.pdf#page=25
Nolvadex Tamoxifen Citrate TABLET;ORAL 017970 ASTRAZENECA 03/09/2006 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088661.pdf
Nulytely Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride FOR SOLUTION;ORAL 019797 BRAINTREE 09/23/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM370636.pdf
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
Pacerone Amiodarone Hydrochloride TABLET;ORAL 075135 UPSHER SMITH LABS 08/13/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf
Parnate Tranylcypromine Sulfate TABLET;ORAL 012342 CONCORDIA PHARMS INC 01/04/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088674.pdf
Pegasys Peginterferon Alfa-2a SYRINGE 103964 HOFFMAN-LA ROCHE 10/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39
Potiga Ezogabine TABLET;ORAL 022345 GLAXOSMITHKLINE 05/20/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA PHARMS 12/19/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf#page=34
Prohance Gadoteridol INJECTABLE;INJECTION 020131 BRACCO 04/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020131s028lbl.pdf#page=1
Promacta Kit Eltrombopag Olamine FOR SUSPENSION;ORAL 207027 NOVARTIS PHARMS CORP 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf#page=29
Qualaquin Quinine Sulfate CAPSULE;ORAL 021799 SUN PHARM INDUSTRIES 07/02/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM192698.pdf
Metoclopramide Hydrochloride Metoclopramide Hydrochloride SOLUTION;ORAL 074703 WOCKHARDT BIO AG 04/08/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM244086.pdf
Mobic Meloxicam TABLET;ORAL 020938 BOEHRINGER INGELHEIM 06/30/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf
Morphabond ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 206544 DAIICHI SANKYO INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf#page=36
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 201517 LANNETT CO INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf#page=26
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
Nucynta Tapentadol Hydrochloride TABLET;ORAL 022304 DEPO NF 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf#page=32
Nucynta ER Tapentadol Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 DEPO NF 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf#page=32
Ocaliva Obeticholic Acid TABLET;ORAL 207999 INTERCEPT PHARMS INC 02/01/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf#page=23
Omontys Peginesatide Acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799 TAKEDA PHARMS USA 12/04/2012 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf
Onsolis Fentanyl Citrate FILM;BUCCAL 022266 BDSI 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf#page=32
Opdivo Nivolumab INJECTABLE;INJECTION 125554 BRISTOL MYERS SQUIBB 08/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s067lbl.pdf#page=87
Lyrica CR Pregabalin TABLET, EXTENDED RELEASE;ORAL 209501 PF PRISM CV 10/11/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209501s000lbl.pdf#page=29
Nexium Esomeprazole Magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153 ASTRAZENECA PHARMS 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33
Nizoral Ketoconazole TABLET;ORAL 018533 JANSSEN PHARMS 02/25/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362592.pdf
Norpramin Desipramine Hydrochloride TABLET;ORAL 014399 US PHARM HOLDINGS 11/09/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf
Novantrone Mitoxantrone Hydrochloride INJECTABLE;INJECTION 019297 EMD SERONO 03/23/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035mg.pdf
Nucynta Tapentadol Hydrochloride SOLUTION;ORAL 203794 DEPOMED INC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000mg.pdf
Nuvigil Armodafinil TABLET;ORAL 021875 CEPHALON 02/07/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231717.pdf
Ocrevus Ocrelizumab INJECTABLE;INJECTION 761053 GENENTECH INC 11/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf#page=17
Omontys Preservative Free Peginesatide Acetate SOLUTION;INTRAVENOUS, SUBCUTANEOUS 202799 TAKEDA PHARMS USA 12/04/2012 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297877.pdf
Onfi Clobazam TABLET;ORAL 202067 LUNDBECK PHARMS LLC 06/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29
Opana ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655 ENDO PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf#page26
Gilenya Fingolimod Hydrochloride CAPSULE;ORAL 022527 NOVARTIS 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022527s024lbl.pdf#page=25
Humira Adalimumab VIAL 125057 ABBVIE INC 10/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=56
Hycodan Homatropine METhylbromide; Hydrocodone Bitartrate TABLET;ORAL 005213 GENUS LIFESCIENCES 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf#page=27
Incivek Telaprevir TABLET;ORAL 201917 VERTEX PHARMS 03/25/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM256383.pdf
Invokamet Canagliflozin; METformin Hydrochloride TABLET;ORAL 204353 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s031lbl.pdf#page=53
Invokamet XR Canagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205879s006lbl.pdf#page=53
Ixifi Infliximab-Qbtx INJECTABLE;INJECTION 761072 PFIZER INC 12/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf#page=33
Jentadueto XR Linagliptin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026 BOEHRINGER INGELHEIM 08/10/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s005lbl.pdf
Keppra Levetiracetam TABLET;ORAL 021035 UCB INC 10/24/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf#page=28
Limbitrol Amitriptyline Hydrochloride; Chlordiazepoxide TABLET;ORAL 016949 HERITAGE PHARMS INC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s040lbl.pdf#page=12
Reglan Metoclopramide Hydrochloride INJECTABLE;INJECTION 017862 WEST-WARD PHARMS INT 11/18/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf
Reglan ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793 MEDA PHARMS 11/30/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf
Renflexis Infliximab-Abda INJECTABLE;INJECTION 761054 SAMSUNG BIOEPSIS CO LTD 04/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054lbl.pdf#page=51
Ritalin LA Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NOVARTIS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021284s034lbl.pdf#page=18
Ritalin-SR Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 018029 NOVARTIS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018029s055lbl.pdf#page=14
Roxicodone Oxycodone Hydrochloride TABLET;ORAL 021011 SPECGX LLC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf#page=27
Rozerem Ramelteon TABLET;ORAL 021782 TAKEDA PHARMS USA 07/13/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011Medguide.pdf
Sabril Vigabatrin TABLET;ORAL 020427 LUNDBECK PHARMS LLC 08/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26
Sarafem Fluoxetine Hydrochloride TABLET;ORAL 021860 APIL 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf#page=33
Selzentry Maraviroc SOLUTION;ORAL 208984 VIIV HLTHCARE 07/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43
Optimark Gadoversetamide INJECTABLE;INJECTION 020937 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s027lbl.pdf#page=13
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 201194 VISTAPHARM 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf#page=29
Oxycontin Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272 PURDUE PHARMA LP 09/26/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM208530.pdf
Palynziq Pegvaliase-Pqpz INJECTABLE;INJECTION 761079 BIOMARIN PHARM 05/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf#page=23
Pamelor Nortriptyline Hydrochloride CAPSULE;ORAL 018013 SPECGX LLC 07/28/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf
Paxil Paroxetine Hydrochloride SUSPENSION;ORAL 020710 APOTEX TECHNOLOGIES 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43
Percodan Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24
Pertzye Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022175 DIGESTIVE CARE INC 07/12/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022175s004lbl.pdf#page=13
Plegridy Peginterferon Beta-1a INJECTABLE;INJECTION 125499 BIOGEN IDEC INC 07/14/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM475804.pdf
Qudexy XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122 UPSHER SMITH LABS 03/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205122s003s005lbl.pdf#page=69
Neurontin Gabapentin TABLET;ORAL 020882 PFIZER PHARMS 10/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf#page=32
Nplate Romiplostim INJECTABLE; SUBCUTANEOUS 125268 AMGEN 06/05/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088667.pdf
Nucynta ER Tapentadol Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 DEPO NF 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf#page=33
Odomzo Sonidegib Phosphate CAPSULE;ORAL 205266 SUN PHARMA GLOBAL 09/18/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205266s002lbl.pdf#page=12
Opana Oxymorphone Hydrochloride TABLET;ORAL 021611 ENDO PHARMS 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf#page=25
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
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 200535 GENUS LIFESCIENCES 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf#page=29
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 201194 VISTAPHARM 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf#page=29
Oxycontin Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272 PURDUE PHARMA LP 09/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf#page=45
Oxycontin Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272 PURDUE PHARMA LP 09/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf#page=45
Oseni Alogliptin Benzoate; Pioglitazone Hydrochloride TABLET;ORAL 022426 TAKEDA PHARMS USA 12/21/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022426s009lbl.pdf#page=42
Oxtellar XR Oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810 SUPERNUS PHARMS 06/17/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202810s000mg.pdf
Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046 ACTAVIS ELIZABETH 09/21/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/079046s000mg.pdf
Pennsaid Diclofenac Sodium SOLUTION;TOPICAL 020947 NUVO PHARMS INC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf
Percodan Aspirin; Oxycodone Hydrochloride TABLET;ORAL 007337 ENDO PHARMS 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24
Percodan Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25
Plavix Clopidogrel Bisulfate TABLET;ORAL 020839 SANOFI AVENTIS US 10/11/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020839s070lbl.pdf#page=23
Prilosec Omeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 COVIS PHARMA BV 08/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf#page=34
Prilosec Omeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 COVIS PHARMA BV 08/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf#page=34
Prolia Denosumab INJECTABLE; SUBCUTANEOUS 125320 AMGEN 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125320s181lbl.pdf#page=27
Kaletra Lopinavir; Ritonavir TABLET;ORAL 021906 ABBVIE 10/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021251s055,021906s050lbl.pdf#page=51
Khedezla Desvenlafaxine TABLET, EXTENDED RELEASE;ORAL 204683 OSMOTICA PHARM CORP 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204683s005lbl.pdf#page=24
Kombiglyze XR Metformin Hydrochloride; Saxagliptin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 ASTRAZENECA AB 02/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf#page=47
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
Lumoxiti Moxetumomab Pasudotox-Tdfk INJECTABLE;INJECTION 761104 ASTRAZENECA AB 09/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf#page=18
Lunesta Eszopiclone TABLET;ORAL 021476 SUNOVION PHARMS INC 11/07/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134691.pdf
Lunesta Eszopiclone TABLET;ORAL 021476 SUNOVION PHARMS INC 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf#page=23
Luvox Fluvoxamine Maleate TABLET;ORAL 021519 ANI PHARMS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021519s009lbl.pdf#page=30
Luvox Fluvoxamine Maleate TABLET; ORAL 022235 JAZZ 04/14/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249169.pdf
Luvox CR Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE;ORAL 022033 JAZZ PHARMS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf#page=26
Sodium Oxybate Sodium Oxybate SOLUTION;ORAL 202090 WEST-WARD PHARMS INT 01/17/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202090lbl.pdf#page=18
Stiolto Respimat Olodaterol Hydrochloride; Tiotropium Bromide SPRAY, METERED;INHALATION 206756 BOEHRINGER INGELHEIM 10/05/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf#page=14
Sutent Sunitinib Malate CAPSULE;ORAL 021938 CPPI CV 11/16/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM219111.pdf
Synalgos-DC Aspirin; Caffeine; Dihydrocodeine Bitartrate CAPSULE;ORAL 011483 SUN PHARM INDUSTRIES 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011483s030lbl.pdf#page=26
Synjardy Empagliflozin; METformin Hydrochloride TABLET;ORAL 206111 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf#page=39
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
Tecentriq Atezolizumab INJECTABLE; INJECTION 761041 GENENTECH INC 10/18/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm530718.pdf
Tivorbex Indomethacin CAPSULE;ORAL 204768 IROKO PHARMS LLC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501662.pdf
Tolectin 600 Tolmetin Sodium TABLET;ORAL 017628 ORTHO MCNEIL JANSSEN 01/22/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf
Trazodone Hydrochloride Trazodone Hydrochloride TABLET;ORAL 071196 APOTEX INC 06/02/2015 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/071196s062lbl.pdf#page=3
Methylin Methylphenidate Hydrochloride SOLUTION;ORAL 021419 SPECGX LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021419s014lbl.pdf#page=12
Metozolv ODT Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 022246 SALIX PHARMS 09/27/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187064.pdf
Mobic Meloxicam SUSPENSION;ORAL 021530 BOEHRINGER INGELHEIM 09/01/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf
Morphine Sulfate Morphine Sulfate SOLUTION;ORAL 022195 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022195s014s016lbl.pdf#page=27
Morphine Sulfate Morphine Sulfate TABLET;ORAL 022207 WEST-WARD PHARMS INT 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022207s007s008lbl.pdf#page=25
MS Contin Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 019516 PURDUE PHARMA LP 09/18/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311374.pdf
Multaq Dronedarone Hydrochloride TABLET;ORAL 022425 SANOFI AVENTIS US 02/12/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM171764.pdf
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
Mydayis Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 SHIRE DEV LLC 06/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf#page=22
Lithium Citrate Lithium Citrate SYRUP;ORAL 018421 WEST-WARD PHARMS INT 10/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017812s031,018421s031,018558s026lbl.pdf#page=19
Lyrica Pregabalin CAPSULE;ORAL 021446 PF PRISM CV 05/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021446s035,022488s013lbl.pdf#page=54
Marplan Isocarboxazid TABLET;ORAL 011961 VALIDUS PHARMS INC 11/08/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088633.pdf
Meridia Sibutramine Hydrochloride CAPSULE;ORAL 020632 ABBOTT 08/04/2010 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035MedGuide.pdf
Mircera Methoxy Polyethylene Glycol-Epoetin Beta SOLUTION; INJECTION 125164 HOFFMAN-LA ROCHE 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf#page=23
Myfortic Mycophenolic Acid TABLET, DELAYED RELEASE;ORAL 050791 NOVARTIS 12/23/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050791s024lbl.pdf#page=25
Myobloc Botulinum Toxin Type B VIAL 103846 ELAN PHARM 06/13/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120Medguide.pdf
Mysoline Primidone TABLET;ORAL 009170 VALEANT 02/19/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009170s035MedGuide.pdf
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 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125511s014lbl.pdf#page=18
Natpara Parathyroid Hormone INJECTABLE;INJECTION 125511 NPS PHARMS INC 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/natparaMedGuide.pdf
Proquin XR Ciprofloxacin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744 DEPOMED INC 08/15/2011 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Proquin XR.pdf
Protonix Pantoprazole Sodium TABLET, DELAYED RELEASE;ORAL 020987 WYETH PHARMS 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf#page=30
Ravicti Glycerol Phenylbutyrate LIQUID;ORAL 203284 HORIZON THERAPS INC 04/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf#page=1
Reclast Zoledronic Acid INJECTABLE;IV (INFUSION) 021817 NOVARTIS 07/07/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021817s027lbl.pdf#page=25
Remeron Mirtazapine TABLET;ORAL 020415 ORGANON USA INC 07/08/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026mg.pdf
Ritalin Methylphenidate Hydrochloride TABLET;ORAL 010187 NOVARTIS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/010187s087lbl.pdf#page=11
Roxybond Oxycodone Hydrochloride TABLET;ORAL 209777 DAIICHI SANKYO INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf#page=43
Sabril Vigabatrin FOR SOLUTION;ORAL 022006 LUNDBECK PHARMS LLC 08/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022006s020,020427s018lbl.pdf#page=26
Signifor Pasireotide Diaspartate SOLUTION;SUBCUTANEOUS 200677 NOVARTIS 03/09/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM332633.pdf
Sinequan Doxepin Hydrochloride CAPSULE;ORAL 016798 PFIZER 07/14/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089129.pdf
Soltamox Tamoxifen Citrate SOLUTION;ORAL 021807 MIDATECH PHARMA US 09/25/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lblMG.pdf
Trelegy Ellipta Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate POWDER;INHALATION 209482 GLAXOSMITHKLINE 04/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf#page=33
Tremfya Guselkumab INJECTABLE;INJECTION 761061 JANSSEN BIOTECH 07/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf#page=14
Trileptal Oxcarbazepine TABLET;ORAL 021014 NOVARTIS 03/22/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26
Truvada Emtricitabine; Tenofovir Disoproxil Fumarate TABLET;ORAL 021752 GILEAD 05/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf#page=42
Tyzeka Telbivudine TABLET;ORAL 022011 NOVARTIS 03/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf#page=17
Tyzeka Telbivudine SOLUTION;ORAL 022154 NOVARTIS 03/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022011S021_022154_S018lbl.pdf#page=17
Ultram Tramadol Hydrochloride TABLET;ORAL 020281 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020281s042s043lbl.pdf#page=45
Viramune XR Nevirapine TABLET, EXTENDED RELEASE;ORAL 201152 BOEHRINGER INGELHEIM 09/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf#page=19
Voltaren Diclofenac Sodium GEL;TOPICAL 022122 GLAXOSMITHKLINE CONS 02/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022122s011lbl.pdf#page=22
Xarelto Rivaroxaban TABLET;ORAL 022406 JANSSEN PHARMS 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022406s024lbl.pdf#page=45
Relistor Methylnaltrexone Bromide SOLUTION;SUBCUTANEOUS 021964 SALIX PHARMS 03/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf#page=29
Remeron Soltab Mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 ORGANON USA INC 07/08/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016mg.pdf
Remicade Infliximab VIAL 103772 CENTOCOR INC 06/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf#page=48
Revlimid Lenalidomide CAPSULE;ORAL 021880 CELGENE 12/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021880s055lbl.pdf#page=42
Rexulti Brexpiprazole TABLET;ORAL 205422 OTSUKA PHARM CO LTD 02/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf#page=28
Rituxan Hycela Hyaluronidase;Rituximab INJECTABLE;INJECTION 761064 GENENTECH INC 06/22/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf#page=29
Savaysa Edoxaban Tosylate TABLET;ORAL 206316 DAIICHI SANKYO INC 09/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206316s012lbl.pdf#page=32
Signifor LAr Kit Pasireotide Pamoate FOR SUSPENSION;INTRAMUSCULAR 203255 NOVARTIS PHARMS CORP 06/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf#page=27
Siliq Brodalumab INJECTABLE;INJECTION 761032 VALEANT LUXEMBOURG 10/09/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf#page=13
Soriatane Acitretin CAPSULE;ORAL 019821 STIEFEL LABS INC 09/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018mg.pdf
Sotret Isotretinoin CAPSULE;ORAL 076041 SUN PHARM INDS LTD 04/12/2012 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Sotret.pdf
Xarelto Rivaroxaban TABLET; ORAL 202439 JANSSEN PHARMS 10/11/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s027lbl.pdf#page=46
Xeljanz XR Tofacitinib Citrate TABLET, EXTENDED RELEASE;ORAL 208246 PFIZER INC 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf#page=50
Zontivity Vorapaxar Sulfate TABLET;ORAL 204886 ARALEZ PHARMS 07/14/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447698.pdf
Optimark Gadoversetamide INJECTABLE;INJECTION 020975 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020975s028lbl.pdf#page=13
Oxaydo Oxycodone Hydrochloride TABLET;ORAL 202080 EGALET US INC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf#page=26
Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE;ORAL 200534 GENUS LIFESCIENCES 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf#page=30
Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION;ORAL 200535 GENUS LIFESCIENCES 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000MedGuide.pdf
Pamelor Nortriptyline Hydrochloride SOLUTION;ORAL 018012 SPECGX LLC 07/28/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf
Paxil Paroxetine Hydrochloride TABLET;ORAL 020031 APOTEX TECHNOLOGIES 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43
Paxil CR Paroxetine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020936 APOTEX TECHNOLOGIES 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020936s053lbl.pdf#page=44
Percodan-Demi Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25
Perforomist Formoterol Fumarate SOLUTION;INHALATION 022007 MYLAN SPECLT 10/17/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214444.pdf
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
Pegintron Peginterferon Alfa-2b SYRINGE 103949 SCHERING 05/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27
Percodan-Demi Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate TABLET;ORAL 007337 ENDO PHARMS 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/007337s049lbl.pdf#page=24
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA PHARMS 12/19/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322359.pdf
Pristiq Desvenlafaxine Succinate TABLET, EXTENDED RELEASE;ORAL 021992 WYETH PHARMS INC 02/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021992s046lbl.pdf#page=35
Promacta Eltrombopag Olamine TABLET;ORAL 022291 NOVARTIS PHARMS CORP 07/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf#page=29
Promacta Kit Eltrombopag Olamine FOR SUSPENSION;ORAL 207027 NOVARTIS PHARMS CORP 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf#page=30
Qmiiz ODT (Meloxicam) Orally Disintegrating Tablets, 7.5 and 15 Mg Meloxicam TABLET, ORALLY DISINTEGRATING;ORAL 211210 TERSERA THERAPS LLC 10/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211210s000lbl.pdf#page=35
Reglan Metoclopramide Hydrochloride TABLET;ORAL 017854 ANI PHARMS 08/29/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf
Sarafem Fluoxetine Hydrochloride TABLET;ORAL 021860 APIL 01/04/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089119.pdf
Silenor Doxepin Hydrochloride TABLET;ORAL 022036 PERNIX THERAPS LLC 12/22/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206668.pdf
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s004lbl.pdf#page=32
Stelara Ustekinumab INJECTABLE; INJECTION 125261 CENTOCOR ORTHO BIOTECH INC 06/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf#page=30
Striverdi Respimat Olodaterol Hydrochloride SPRAY, METERED;INHALATION 203108 BOEHRINGER INGELHEIM 04/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/striverdi respimatMedGuide2016.pdf
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 020733 INDIVIOR INC 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32
Subutex Buprenorphine Hydrochloride TABLET;SUBLINGUAL 020732 INDIVIOR INC 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32
Supprelin LA Histrelin Acetate IMPLANT;SUBCUTANEOUS 022058 ENDO PHARM 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022058s014s015lbl.pdf#page=19
Surmontil Trimipramine Maleate CAPSULE;ORAL 016792 ODYSSEY PHARMS 09/30/2014 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016792s037lbl.pdf#page=12
Synjardy XR Empagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208658s004lbl.pdf#page=39
Synribo Omacetaxine Mepesuccinate POWDER;SUBCUTANEOUS 203585 TEVA PHARMS INTL 06/21/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM396919.pdf
Tecentriq Atezolizumab INJECTABLE;INJECTION 761034 GENENTECH INC 07/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s011lbl.pdf#page=27
Naprosyn Naproxen TABLET;ORAL 017581 ATNAHS PHARMA US 03/10/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf#page=22
Nasonex Mometasone Furoate SPRAY, METERED;NASAL 020762 MERCK SHARP DOHME 06/22/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s053lbl.pdf#page=12
Nexium Esomeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957 ASTRAZENECA PHARMS 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33
Olumiant Baricitinib TABLET;ORAL 207924 ELI LILLY AND CO 05/31/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924s000lbl.pdf#page=18
Omniscan Gadodiamide INJECTABLE;INJECTION 020123 GE HEALTHCARE 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf#page=1
Onfi Clobazam SUSPENSION;ORAL 203993 LUNDBECK PHARMS LLC 06/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202067s005,203993s007lbl.pdf#page=29
Opana Oxymorphone Hydrochloride TABLET;ORAL 021611 ENDO PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf#page=26
Opana ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610 ENDO PHARMS 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021610s022lbl.pdf#page=25
Opana ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610 ENDO PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021610s025s026lbl.pdf#page=26
Pancreaze Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022523 VIVUS INC 08/04/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022523MedGuide.pdf
Nerlynx Neratinib Maleate TABLET;ORAL 208051 PUMA BIOTECH 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf#page=19
Noroxin Norfloxacin TABLET;ORAL 019384 MERCK 07/26/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf
Nucynta Tapentadol Hydrochloride TABLET;ORAL 022304 DEPO NF 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf#page=32
Oleptro Trazodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411 ANGELINI PHARMA 07/17/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf
Opsumit Macitentan TABLET;ORAL 204410 ACTELION PHARMS LTD 10/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204410s010lbl.pdf#page=20
Optimark in Plastic Container Gadoversetamide INJECTABLE;INJECTION 020976 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=43
Osmoprep Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate TABLET;ORAL 021892 SALIX PHARMS 06/21/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006mg.pdf
Palladone Hydromorphone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044 PURDUE PHARMA LP 04/16/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088670.pdf
Peganone Ethotoin TABLET;ORAL 010841 RECORDATI RARE 02/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf
Percodan Aspirin; Oxycodone Hydrochloride TABLET;ORAL 007337 ENDO PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/007337s050s051lbl.pdf#page=25
Technivie Ombitasvir; Paritaprevir; Ritonavir TABLET;ORAL 207931 ABBVIE INC 07/23/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207931s012lbl.pdf#page=38
Testosterone Testosterone GEL;TRANSDERMAL 202763 ANI PHARMS INC 10/25/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000mg.pdf
Tolectin Tolmetin Sodium TABLET;ORAL 017628 ORTHO MCNEIL JANSSEN 01/22/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf
Topamax Topiramate TABLET;ORAL 020505 JANSSEN PHARMS 06/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020505s058_020844_49lbl.pdf#page=50
Tracleer Bosentan TABLET, FOR SUSPENSION;ORAL 209279 ACTELION PHARMS 10/25/2018 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209279Orig1s000ltr.pdf#page=9
Triptodur Kit Triptorelin Pamoate FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 208956 ARBOR PHARMS LLC 06/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208956s000lbl.pdf#page=12
Tuzistra XR Chlorpheniramine Polistirex; Codeine Polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768 TRIS PHARMA INC 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf#page=27
Ultresa Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022222 FOREST LABS INC 09/30/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM296221.pdf
Valchlor Mechlorethamine Hydrochloride GEL;TOPICAL 202317 HELSINN 12/22/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM366908.pdf
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
Strattera Atomoxetine Hydrochloride CAPSULE;ORAL 021411 LILLY 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf#page=19
Suclear Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Potassium Sulfate; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate SOLUTION;ORAL 203595 BRAINTREE LABS 08/15/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337734.pdf
Sylatron Peginterferon Alfa-2b VIAL 103949 SCHERING 05/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27
Symproic Naldemedine Tosylate TABLET;ORAL 208854 SHIONOGI INC 01/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf#page=13
Synjardy Empagliflozin; METformin Hydrochloride TABLET;ORAL 206111 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf#page=39
Tafinlar Dabrafenib Mesylate CAPSULE;ORAL 202806 NOVARTIS PHARMS CORP 05/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf#page=37
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
Tolectin DS Tolmetin Sodium CAPSULE;ORAL 018084 ORTHO MCNEIL JANSSEN 01/22/2008 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089162.pdf
Tracleer Bosentan TABLET;ORAL 021290 ACTELION PHARMS LTD 10/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021290s034lbl.pdf#page=30
Tranxene Clorazepate Dipotassium TABLET;ORAL 017105 RECORDATI RARE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf#page=10
Effient Prasugrel Hydrochloride TABLET;ORAL 022307 ELI LILLY AND CO 03/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf#page=19
Emsam Selegiline SYSTEM; TRANSDERMAL 021708 SOMERSET 02/27/2006 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf
Fentora Fentanyl Citrate TABLET;BUCCAL, SUBLINGUAL 021947 CEPHALON 09/07/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021947s019lbl.pdf#page=20
Floxin Ofloxacin TABLET;ORAL 019735 JANSSEN PHARMS 02/25/2011 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019735s061MedG.pdf
Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET;ORAL 202133 ALVOGEN 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202133s004s005lbl.pdf#page=40
Focalin Dexmethylphenidate Hydrochloride TABLET;ORAL 021278 NOVARTIS 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021278s023lbl.pdf#page=14
Foradil Certihaler Formoterol Fumarate POWDER;INHALATION 021592 NOVARTIS 06/02/2010 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088603.pdf
Fosrenol Lanthanum Carbonate TABLET, CHEWABLE;ORAL 021468 SHIRE LLC 11/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf#page=12
Fycompa Perampanel SUSPENSION;ORAL 208277 EISAI INC 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf#page=24
Gabitril Tiagabine Hydrochloride TABLET;ORAL 020646 CEPHALON 08/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229203.pdf
Gattex Kit Teduglutide Recombinant POWDER;SUBCUTANEOUS 203441 NPS PHARMS INC 03/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf#page=10
Soltamox Tamoxifen Citrate SOLUTION;ORAL 021807 MIDATECH PHARMA US 09/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf#page=36
Symbyax Fluoxetine Hydrochloride; Olanzapine CAPSULE;ORAL 021520 LILLY 03/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021520s050lbl.pdf#page=42
Synalgos-DC Aspirin; Caffeine; Dihydrocodeine Bitartrate CAPSULE;ORAL 011483 SUN PHARM INDUSTRIES 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/011483s031s032lbl.pdf#page=27
Tradjenta Linagliptin TABLET;ORAL 201280 BOEHRINGER INGELHEIM 08/10/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf#page=14
Tranxene SD Clorazepate Dipotassium TABLET;ORAL 017105 RECORDATI RARE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf#page=10
Trileptal Oxcarbazepine SUSPENSION;ORAL 021285 NOVARTIS 03/22/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021014s042,021285s035lbl.pdf#page=26
Trintellix Vortioxetine Hydrobromide TABLET;ORAL 204447 TAKEDA PHARMS USA 10/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204447s017lbl.pdf#page=29
Trintellix Vortioxetine Hydrobromide TABLET;ORAL 204447 TAKEDA PHARMS USA 10/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/BRINTELLIXMedGuide.pdf
Trulicity Dulaglutide INJECTABLE;INJECTION 125469 ELI LILLY AND CO 09/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf#page=21
Ultram Tramadol Hydrochloride TABLET;ORAL 020281 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s039lbl.pdf#page=44
Venclexta Venetoclax TABLET;ORAL 208573 ABBVIE INC 09/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208573s004s005lbl.pdf#page=30
Vimpat Lacosamide SOLUTION;INTRAVENOUS 022254 UCB INC 11/11/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf#page=20
Vimpat Lacosamide SOLUTION;ORAL 022255 UCB INC 11/11/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf#page=20
Vituz Chlorpheniramine Maleate; Hydrocodone Bitartrate SOLUTION;ORAL 204307 CYPRESS PHARM 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204307s004lbl.pdf#page=25
Xanax Alprazolam TABLET;ORAL 018276 PHARMACIA AND UPJOHN 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018276s052lbl.pdf#page=24
Xarelto Rivaroxaban TABLET; ORAL 202439 JANSSEN PHARMS 10/11/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202439s025lbl.pdf#page=53
Xeljanz XR Tofacitinib Citrate TABLET, EXTENDED RELEASE;ORAL 208246 PFIZER INC 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf#page=49
Xeomin Incobotulinumtoxina INJECTABLE; INJECTION 125360 MERZ PHARMS 07/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf#page=19
Xiaflex Collagenase Clostridium Histolyticum SOLUTION; INJECTION 125338 AUXILIUM PHARMS 09/26/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040mg.pdf
Xigduo XR Dapagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649 ASTRAZENECA AB 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205649s010lbl.pdf#page=40
Pegasys Peginterferon Alfa-2a VIAL; SUBCUTANEOUS 103964 HOFFMAN-LA ROCHE 10/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103964s5270lbl.pdf#page=39
Perforomist Formoterol Fumarate SOLUTION;INHALATION 022007 MYLAN SPECLT 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf#page=19
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
Pomalyst Pomalidomide CAPSULE;ORAL 204026 CELGENE 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf#page=31
Ponstel Mefenamic Acid CAPSULE;ORAL 015034 SHIONOGI INC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088692.pdf
Prevacid Lansoprazole CAPSULE, DELAYED REL PELLETS;ORAL 020406 TAKEDA PHARMS USA 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38
Prevacid Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 021428 TAKEDA PHARMS USA 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf#page=38
Priftin Rifapentine TABLET;ORAL 021024 SANOFI AVENTIS US 08/07/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426514.pdf
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
Roxybond Oxycodone Hydrochloride TABLET;ORAL 209777 DAIICHI SANKYO INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf#page=35
Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104 OSMOTICA PHARM 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022104s016lbl.pdf#page=35
Vibativ Telavancin INJECTABLE; INJECTION 022407 THERAVANCE INC 06/21/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf
Viibryd Vilazodone Hydrochloride TABLET;ORAL 022567 ALLERGAN SALES LLC 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022567s020lbl.pdf#page=17
Wellbutrin SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358 GLAXOSMITHKLINE 08/11/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020358s060lbl.pdf#page=34
Xartemis XR Acetaminophen; Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031 MALLINCKRODT INC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204031s003lbl.pdf#page=32
Xeljanz Tofacitinib Citrate TABLET;ORAL 203214 PF PRISM CV 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf#page=49
Xyosted (Autoinjector) Testosterone Enanthate SOLUTION;SUBCUTANEOUS 209863 ANTARES PHARMA INC 09/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209863s000lbl.pdf#page=16
Yervoy Ipilimumab INJECTABLE; INJECTION 125377 BRISTOL MYERS SQUIBB 07/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf#page=50
Zutripro Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride SOLUTION;ORAL 022439 CYPRESS PHARM 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022439s010lbl.pdf#page=28
Xtampza ER Oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 COLLEGIUM PHARM INC 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf#page=36
Zegerid Omeprazole; Sodium Bicarbonate CAPSULE;ORAL 021849 SANTARUS INC 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf#page=26
Zenpep Pancrelipase (Amylase;Lipase;Protease) CAPSULE, DELAYED RELEASE;ORAL 022210 FOREST LABS INC 12/19/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM180714.pdf
Zohydro ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880 PERNIX IRELAND PAIN 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf#page=29
Zolpidem Tartrate Zolpidem Tartrate TABLET;ORAL 076062 VIVIMED GLOBAL 04/23/2007 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Zolpidem.pdf
Segluromet Ertugliflozin; METformin Hydrochloride TABLET;ORAL 209806 MERCK SHARP DOHME 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209806s001lbl.pdf#page=32
Seroquel Quetiapine Fumarate TABLET;ORAL 020639 ASTRAZENECA PHARMS 02/23/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089126.pdf
Sirturo Bedaquiline Fumarate TABLET;ORAL 204384 JANSSEN THERAP 02/10/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333729.pdf
Soliqua 100/33 Insulin Glargine; Lixisenatide SOLUTION;SUBCUTANEOUS 208673 SANOFI-AVENTIS US 09/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208673s002lbl.pdf#page=37
Soliris Eculizumab INJECTABLE; IV (INFUSION) 125166 ALEXION PHARM 07/25/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125166Orig1s427s428MedGuide.pdf
Spritam Levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 APRECIA PHARMS 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207958s008lbl.pdf#page=34
Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209805s001lbl.pdf#page=32
Sublocade Buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 INDIVIOR INC 03/05/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf#page=40
Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 INDIVIOR INC 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022410s033,020732s019,020733s023lbl.pdf#page=32
Subsys Fentanyl SPRAY;SUBLINGUAL 202788 INSYS DEV CO INC 09/07/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf#page=38
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
Prilosec Omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810 ASTRAZENECA PHARMS 12/19/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf
Prilosec Omeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056 COVIS PHARMA BV 08/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s021lbl.pdf#page=14
Probuphine Buprenorphine Hydrochloride IMPLANT;IMPLANTATION 204442 TITAN PHARMS 11/01/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf
Propylthiouracil Propylthiouracil TABLET;ORAL 006188 DAVA PHARMS INC 09/19/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020MedGuide.pdf
Protonix Pantoprazole Sodium FOR SUSPENSION, DELAYED RELEASE;ORAL 022020 WYETH PHARMS 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020987s053,022020s015lbl.pdf#page=30
Protopic Tacrolimus OINTMENT;TOPICAL 050777 LEO PHARMA AS 11/04/2011 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 03/24/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28
Horizant Gabapentin Enacarbil TABLET, EXTENDED RELEASE;ORAL 022399 ARBOR PHARMS LLC 10/29/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250398.pdf
Humira Adalimumab SYRINGE 125057 ABBVIE INC 10/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s409lbl.pdf#page=56
Hydrea Hydroxyurea CAPSULE;ORAL 016295 BRISTOL MYERS SQUIBB 12/18/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf#page=15
Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 PADDOCK LLC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204278Orig1s000MG.pdf
Hyrimoz Adalimumab-Adaz INJECTABLE;INJECTION 761071 SANDOZ INC 10/30/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pdf#page=36
Hysingla Hydrocodone Bitartrate TABLET, EXTENDED RELEASE;ORAL 206627 PURDUE PHARMA LP 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf#page=35
Iclusig Ponatinib Hydrochloride TABLET;ORAL 203469 ARIAD 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203469s030lbl.pdf#page=29
Idhifa Enasidenib Mesylate TABLET;ORAL 209606 CELGENE CORP 08/01/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf#page=16
Intermezzo Zolpidem Tartrate TABLET;SUBLINGUAL 022328 PURDUE PHARMA 11/13/2015 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf#page=18
Invirase Saquinavir Mesylate CAPSULE;ORAL 020628 HOFFMANN LA ROCHE 03/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020628s046,021785s022lbl.pdf#page=25
Suprep Bowel Prep Kit Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate SOLUTION;ORAL 022372 BRAINTREE LABS 11/06/2012 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022372s000MedGuide.pdf
Synjardy XR Empagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf#page=39
Targiniq Naloxone Hydrochloride; Oxycodone Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777 PURDUE PHARMA LP 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf#page=46
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 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
Tegsedi Inotersen INJECTABLE;INJECTION 211172 IONIS PHARMS INC 10/05/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211172lbl.pdf#page=41
Toradol Ketorolac Tromethamine TABLET;ORAL 019645 ROCHE PALO 03/26/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089165.pdf
Treximet Naproxen Sodium; Sumatriptan Succinate TABLET;ORAL 021926 PERNIX IRELAND LTD 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089804.pdf
Troxyca ER Naltrexone Hydrochloride; Oxycodone Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621 PFIZER INC 05/26/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207621s004lbl.pdf#page=32
Videx Didanosine FOR SOLUTION;ORAL 020156 BRISTOL-MYERS SQUIBB 01/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020156s053lbl.pdf#page=32
Pexeva Paroxetine Mesylate TABLET;ORAL 021299 SEBELA IRELAND LTD 01/04/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf#page=38
Phenergan VC W/ Codeine Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride SYRUP;ORAL 008306 ANI PHARMS 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf#page=29
Pradaxa Dabigatran Etexilate Mesylate CAPSULE;ORAL 022512 BOEHRINGER INGELHEIM 03/13/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf
Qsymia Phentermine Hydrochloride; Topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580 VIVUS 03/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf#page=37
Rapamune Sirolimus TABLET;ORAL 021110 PF PRISM CV 05/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s061,021110s080lbl.pdf#page=41
Rebetol Ribavirin SOLUTION;ORAL 021546 SCHERING 05/21/2015 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089017.pdf
Rebif Interferon Beta-1a SYRINGE 103780 SERONO INC 09/27/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089019.pdf
Relistor Methylnaltrexone Bromide TABLET;ORAL 208271 SALIX PHARMS INC 03/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf#page=29
Restoril Temazepam CAPSULE;ORAL 018163 SPECGX LLC 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf#page=13
Rezira Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride SOLUTION;ORAL 022442 CYPRESS PHARM 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022442s010lbl.pdf#page=26
Invokamet XR Canagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205879s009lbl.pdf#page=54
Invokana Canagliflozin TABLET;ORAL 204042 JANSSEN PHARMS 10/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf#page=45
Jardiance Empagliflozin TABLET;ORAL 204629 BOEHRINGER INGELHEIM 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf#page=32
Kazano Alogliptin Benzoate; METformin Hydrochloride TABLET;ORAL 203414 TAKEDA PHARMS USA 02/15/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM337729.pdf
Keppra Levetiracetam SOLUTION;ORAL 021505 UCB INC 10/24/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf#page=28
Keppra XR Levetiracetam TABLET, EXTENDED RELEASE;ORAL 022285 UCB INC 10/24/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022285s026lbl.pdf#page=21
Lacosamide Lacosamide TABLET;ORAL 204855 ACTAVIS LABS FL INC 10/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LACOSAMIDE TABLETSMedGuide.pdf
Lamictal XR Lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115 GLAXOSMITHKLINE LLC 07/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022115s022lbl.pdf#page=49
Lariam Mefloquine Hydrochloride TABLET;ORAL 019591 ROCHE 04/29/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088616.pdf
Lariam Mefloquine Hydrochloride TABLET;ORAL 019591 ROCHE 04/29/2011 https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf#page=13
Letairis Ambrisentan TABLET;ORAL 022081 GILEAD 09/27/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf
Qtern Dapagliflozin; Saxagliptin Hydrochloride TABLET;ORAL 209091 ASTRAZENECA AB 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s000lbl.pdf
Quillivant XR Methylphenidate Hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100 NEXTWAVE PHARMS 01/24/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202100s012lbl.pdf#page=14
Serevent Salmeterol Xinafoate POWDER;INHALATION 020692 GLAXOSMITHKLINE 09/30/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf
Siklos Hydroxyurea TABLET;ORAL 208843 ADDMEDICA SAS 12/21/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf#page=17
Sonata Zaleplon CAPSULE;ORAL 020859 PFIZER 04/19/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM349707.pdf
Steglatro Ertugliflozin TABLET;ORAL 209803 MERCK SHARP DOHME 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf#page=24
Sustol Granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445 HERON THERAPS INC 08/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524796.pdf
Symlin Pramlintide Acetate INJECTABLE;SUBCUTANEOUS 021332 ASTRAZENECA AB 03/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf
Thalomid Thalidomide CAPSULE;ORAL 020785 CELGENE 12/29/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020785s065lbl.pdf#page=25
Topamax Topiramate CAPSULE;ORAL 020844 JANSSEN PHARMS 06/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf#page=50
Tranxene Clorazepate Dipotassium CAPSULE;ORAL 017105 RECORDATI RARE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017105s079lbl.pdf#page=10
Trilipix Choline Fenofibrate CAPSULE, DELAYED RELEASE;ORAL 022224 ABBVIE 11/07/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022224s007s008mg.pdf
Triumeq Abacavir Sulfate; Dolutegravir Sodium; LAmivudine TABLET;ORAL 205551 VIIV HLTHCARE 09/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205551s010lbl.pdf#page=38
Tuxarin ER Chlorpheniramine Maleate; Codeine Phosphate TABLET, EXTENDED RELEASE;ORAL 206323 SPRIASO LLC 06/28/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf#page=28
Victoza Liraglutide Recombinant SOLUTION;SUBCUTANEOUS 022341 NOVO NORDISK INC 08/25/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf#page=40
Viekira XR Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir TABLET, EXTENDED RELEASE;ORAL 208624 ABBVIE INC 07/23/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf?page48
Viokace Pancrelipase (Amylase;Lipase;Protease) TABLET;ORAL 022542 FOREST LABS INC 07/29/2014 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000MG.pdf
Viramune Nevirapine TABLET;ORAL 020636 BOEHRINGER INGELHEIM 09/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf#page=19
Vivactil Protriptyline Hydrochloride TABLET;ORAL 016012 TEVA WOMENS 07/17/2014 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/Vivactil.pdf
Voltaren Diclofenac Sodium TABLET, DELAYED RELEASE;ORAL 019201 NOVARTIS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089822.pdf
Wellbutrin Bupropion Hydrochloride TABLET;ORAL 018644 GLAXOSMITHKLINE 08/11/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s053lbl.pdf#page=30
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
Trulance Plecanatide TABLET;ORAL 208745 SYNERGY PHARMS 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208745s001lbl.pdf#page=14
Vibativ Telavancin Hydrochloride POWDER;INTRAVENOUS 022110 THERAVANCE BIOPHARMA 05/24/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM183838.pdf
Viberzi Eluxadoline TABLET;ORAL 206940 ALLERGAN HOLDINGS 06/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s006lbl.pdf#page=19
Vimpat Lacosamide TABLET;ORAL 022253 UCB INC 11/11/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf#page=20
Viramune Nevirapine SUSPENSION;ORAL 020933 BOEHRINGER INGELHEIM 09/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf#page=19
Vogelxo Testosterone GEL, METERED;TRANSDERMAL 204399 UPSHER SMITH LABS 10/25/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204399s004lbl.pdf#page=22
Vogelxo Testosterone GEL;TRANSDERMAL 204399 UPSHER SMITH LABS 10/25/2016 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204399s004lbl.pdf#page=22
Vyvanse Lisdexamfetamine Dimesylate CAPSULE;ORAL 021977 SHIRE DEVELOPMENT 07/31/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/ 021977s034,208510s002lbl.pdf#page=38
Xanax XR Alprazolam TABLET, EXTENDED RELEASE;ORAL 021434 PHARMACIA AND UPJOHN 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021434s016lbl.pdf#page=24
Wellbutrin XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515 VALEANT INTL 05/04/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021515s036lbl.pdf#page=28
Xarelto Rivaroxaban TABLET;ORAL 022406 JANSSEN PHARMS 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s029lbl.pdf#page=46
Yondelis Trabectedin POWDER;INTRAVENOUS 207953 JANSSEN PRODS 06/29/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s004lbl.pdf#page=20
Zarontin Ethosuximide CAPSULE;ORAL 012380 PARKE DAVIS 05/17/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034mg.pdf
Zortress Everolimus TABLET;ORAL 021560 NOVARTIS 01/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf#page=32
Zyprexa Relprevv Olanzapine Pamoate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022173 ELI LILLY CO 03/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022173s029lbl.pdf#page=28
Vivitrol Naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897 ALKERMES 12/12/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206669.pdf
Voltaren-XR Diclofenac Sodium TABLET, EXTENDED RELEASE;ORAL 020254 NOVARTIS 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501669.pdf
Votrient Pazopanib Hydrochloride TABLET;ORAL 022465 NOVARTIS PHARMS CORP 05/31/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022465s024s025lbl.pdf#page=26
Vyvanse Lisdexamfetamine Dimesylate TABLET, CHEWABLE;ORAL 208510 SHIRE DEV LLC 07/31/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf#page=38
Xgeva Denosumab INJECTABLE; SUBCUTANEOUS 125320 AMGEN 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125320s181lbl.pdf#page=27
Zerit Stavudine FOR SOLUTION;ORAL 020413 BRISTOL MYERS SQUIBB 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf#page=28
Zohydro ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880 PERNIX IRELAND PAIN 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf#page=28
Zoloft Sertraline Hydrochloride TABLET;ORAL 019839 PFIZER 12/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf#page=27
Zonegran Zonisamide CAPSULE;ORAL 020789 SUNOVION PHARMS INC 04/06/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152828.pdf
Zubsolv Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 204242 OREXO US INC 10/31/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362203.pdf
Ribasphere Ribavirin CAPSULE;ORAL 076203 KADMON PHARMS LLC 05/31/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111342.pdf
Rituxan Rituximab VIAL 103705 GENENTECH 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf#page=42
Rituxan Rituximab VIAL 103705 GENENTECH 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5451lbl.pdf#page=42
Roxicodone Oxycodone Hydrochloride TABLET;ORAL 021011 SPECGX LLC 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf#page=26
Sarafem Fluoxetine Hydrochloride CAPSULE;ORAL 018936 ELI LILLY AND CO 03/24/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf#page=28
Selzentry Maraviroc TABLET;ORAL 022128 VIIV HLTHCARE 07/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf#page=43
Simponi Golimumab INJECTABLE; INJECTION 125289 CENTOCOR ORTHO BIOTECH INC 03/06/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s139lbl.pdf#page=38
Simponi Aria Golimumab INJECTABLE; INJECTION 125433 JANSSEN BIOTECH 02/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf#page=28
Spritam Levetiracetam TABLET, FOR SUSPENSION;ORAL 207958 APRECIA PHARMS 09/12/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207958s004lbl.pdf#page=36
Sprix Ketorolac Tromethamine SPRAY, METERED;NASAL 022382 EGALET US INC 01/22/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf#page=20
Symbicort Budesonide; Formoterol Fumarate Dihydrate AEROSOL, METERED;INHALATION 021929 ASTRAZENECA 12/20/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf#page=46
Zurampic Lesinurad TABLET;ORAL 207988 IRONWOOD PHARMS INC 08/04/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf#page=17
Zyban Bupropion Hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711 GLAXOSMITHKLINE 05/04/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020711s045s046s047lbl.pdf#page=37
Zyprexa Olanzapine INJECTABLE;INTRAMUSCULAR 021253 LILLY 03/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf#page=36
Levaquin Levofloxacin TABLET;ORAL 020634 JANSSEN PHARMS 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s070lbl.pdf#page=52
Levaquin in Dextrose 5% in Plastic Container Levofloxacin INJECTABLE;INJECTION 020635 JANSSEN PHARMS 02/08/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
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
Linzess Linaclotide CAPSULE;ORAL 202811 ALLERGAN SALES LLC 03/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf#page=20
Lunesta Eszopiclone TABLET;ORAL 021476 SUNOVION PHARMS INC 11/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021476s036lbl.pdf#page=26
Lynparza Olaparib CAPSULE;ORAL 206162 ASTRAZENECA PHARMS 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf#page=16
Magnevist Gadopentetate Dimeglumine INJECTABLE;INJECTION 019596 BAYER HLTHCARE 07/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf#page=12
Morphabond ER Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 206544 DAIICHI SANKYO INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf#page=35
Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride SOLUTION;INTRAVENOUS 205572 FRESENIUS KABI USA 10/18/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088619.pdf
MS Contin Morphine Sulfate TABLET, EXTENDED RELEASE;ORAL 019516 PURDUE PHARMA LP 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf#page=28
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
Xeljanz Tofacitinib Citrate TABLET;ORAL 203214 PF PRISM CV 10/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf#page=50
Xolair Omalizumab VIAL 103976 GENENTECH 09/28/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089829.pdf
Yupelri Revefenacin SOLUTION;INHALATION 210598 THERAVANCE BIOPHARMA 11/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210598s000lbl.pdf#page=16
Zegerid Omeprazole; Sodium Bicarbonate FOR SUSPENSION;ORAL 021636 SANTARUS INC 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf#page=26
Zelboraf Vemurafenib TABLET;ORAL 202429 HOFFMANN LA ROCHE 11/06/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s016lbl.pdf#page=21
Zerit Stavudine CAPSULE;ORAL 020412 BRISTOL MYERS SQUIBB 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020412s040,020413s032lbl.pdf#page=28
Ziagen Abacavir Sulfate TABLET;ORAL 020977 VIIV HLTHCARE 05/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf#page=27
Ziagen Abacavir Sulfate SOLUTION;ORAL 020978 VIIV HLTHCARE 05/09/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020977s033s034,020978s036s037lbl.pdf#page=27
Zipsor Diclofenac Potassium CAPSULE;ORAL 022202 ASSERTIO 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243355.pdf
Zyprexa Olanzapine TABLET;ORAL 020592 LILLY 03/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf#page=36
Zyprexa Zydis Olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086 LILLY 03/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020592s071,021086s046,021253s059lbl.pdf#page=36
Myalept Metreleptin INJECTABLE;INJECTION 125390 AEGERION 12/11/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125390s010lbl.pdf#page=14
Nexium Esomeprazole Magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101 ASTRAZENECA PHARMS 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021153s053,022101s017,021957s020lbl.pdf#page=33
Nulojix Belatacept INJECTABLE; INJECTION 125288 BRISTOL MYERS SQUIBB 04/13/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf#page=49
Onglyza Saxagliptin Hydrochloride TABLET;ORAL 022350 ASTRAZENECA AB 02/27/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf#page=31
Opsumit Macitentan TABLET;ORAL 204410 ACTELION PHARMS LTD 10/16/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf#page=18
Optimark Gadoversetamide INJECTABLE;INJECTION 020937 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=14
Optimark Gadoversetamide INJECTABLE;INJECTION 020975 LIEBEL-FLARSHEIM 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s028,020975s029,020976s030lbl.pdf#page=29
Oxaydo Oxycodone Hydrochloride TABLET;ORAL 202080 EGALET US INC 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf#page=27
Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE;ORAL 200534 GENUS LIFESCIENCES 09/18/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf#pg=30
Pegintron Peginterferon Alfa-2b VIAL 103949 SCHERING 05/25/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103949s5311lbl.pdf#page=27
Sympazan Clobazam FILM;ORAL 210833 AQUESTIVE THERAPEUTICS 11/01/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210833s000lbl.pdf#page=26
Synarel Nafarelin Acetate SPRAY, METERED;NASAL 019886 GD SEARLE LLC 05/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019886s033s035lbl.pdf#page=28
Tasigna Nilotinib Hydrochloride CAPSULE;ORAL 022068 NOVARTIS 08/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s029lbl.pdf#page=35
Tibsovo Ivosidenib TABLET;ORAL 211192 AGIOS PHARMS INC 07/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf#page=18
Tofranil-Pm Imipramine Pamoate CAPSULE;ORAL 017090 SPECGX LLC 07/28/2014 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326090.pdf
Topamax Sprinkle Topiramate CAPSULE;ORAL 020844 JANSSEN PHARMS 06/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf#page=50
Tridione Trimethadione SOLUTION;ORAL 005856 ABBVIE 06/07/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM308402.pdf
Trokendi XR Topiramate CAPSULE, EXTENDED RELEASE;ORAL 201635 SUPERNUS PHARMS 01/03/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201635s011s017lbl.pdf#page=58
Tymlos Abaloparatide SOLUTION;SUBCUTANEOUS 208743 RADIUS HEALTH INC 10/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208743lbl.pdf#page=18
Ultracet Acetaminophen; Tramadol Hydrochloride TABLET;ORAL 021123 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021123s016s017lbl.pdf#page=46
Valium Diazepam TABLET;ORAL 013263 ROCHE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf#page=14
Plenvu Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate FOR SOLUTION;ORAL 209381 SALIX PHARMS INC 05/04/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf#page=17
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
Prohance Multipack Gadoteridol INJECTABLE;INJECTION 021489 BRACCO 11/02/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf#page=1
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
Quillichew ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NEXTWAVE PHARMS 02/28/2017 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207960s005lbl.pdf#page=13
Rapamune Sirolimus SOLUTION;ORAL 021083 PF PRISM CV 05/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021083s062,021110s081lbl.pdf#page=41
Retacrit Epoetin Alfa-Epbx INJECTABLE;INJECTION 125545 HOSPIRA INC 05/15/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf#page=28
Samsca Tolvaptan TABLET;ORAL 022275 OTSUKA AMERICA PHARM 04/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022275s016lbl.pdf#page=24
Savella Milnacipran Hydrochloride TABLET;ORAL 022256 ALLERGAN SALES LLC 12/19/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022256s023lbl.pdf#page=30
Vicoprofen Hydrocodone Bitartrate; Ibuprofen TABLET;ORAL 020716 ABBVIE 12/16/2016 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020716s012s013s014s015s016lbl.pdf#page=36
Victrelis Boceprevir CAPSULE;ORAL 202258 MERCK SHARP DOHME 01/30/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255471.pdf
Videx EC Didanosine CAPSULE, DELAYED REL PELLETS;ORAL 021183 BRISTOL MYERS SQUIBB 01/25/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021183s025MG.pdf
Viekira Pak (Copackaged) Dasabuvir Sodium ; Ombitasvir; Paritaprevir; Ritonavir TABLET, TABLET;ORAL 206619 ABBVIE INC 07/23/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206619s018lbl.pdf#page=50
Viramune XR Nevirapine TABLET, EXTENDED RELEASE;ORAL 201152 BOEHRINGER INGELHEIM 09/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201152s013lbl.pdf#page=18
Visicol Sodium Phosphate, Dibasic Anhydrous; Sodium Phosphate, Monobasic, Monohydrate TABLET;ORAL 021097 SALIX PHARMS 03/07/2013 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134684.pdf
Xolair Omalizumab VIAL 103976 GENENTECH 09/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf#page=32
Xtampza ER Oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 COLLEGIUM PHARM INC 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208090s004lbl.pdf#page=35
Xyrem Sodium Oxybate SOLUTION;ORAL 021196 JAZZ PHARMS 10/26/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021196s030lbl.pdf#page=26
Yosprala Aspirin; Omeprazole TABLET, DELAYED RELEASE;ORAL 205103 GENUS LIFESCIENCES 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205103s004lbl.pdf#page=37
Zolpimist Zolpidem Tartrate SPRAY, METERED;ORAL 022196 MAGNA PHARMS 09/28/2011 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143465.pdf
Saxenda Liraglutide Recombinant SOLUTION;SUBCUTANEOUS 206321 NOVO NORDISK INC 10/19/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206321s004s006lbl.pdf#page=26
Solaraze Diclofenac Sodium GEL;TOPICAL 021005 FOUGERA PHARMS 05/16/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501655.pdf
Steglatro Ertugliflozin TABLET;ORAL 209803 MERCK SHARP DOHME 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf#page=25
Taltz Ixekizumab INJECTABLE;INJECTION 125521 ELI LILLY AND CO 05/17/2018 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM493178.pdf
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
Testim Testosterone GEL;TRANSDERMAL 021454 AUXILIUM PHARMS LLC 10/25/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188475.pdf
Tikosyn Dofetilide CAPSULE;ORAL 020931 PFIZER 03/08/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266314.pdf
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
Trizivir Abacavir Sulfate; LAmivudine; Zidovudine TABLET;ORAL 021205 VIIV HLTHCARE 04/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021205s037lbl.pdf#page=34
Trulicity Dulaglutide INJECTABLE;INJECTION 125469 ELI LILLY AND CO 09/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf#page=22
Tussionex Pennkinetic Chlorpheniramine Polistirex; Hydrocodone Polistirex SUSPENSION, EXTENDED RELEASE;ORAL 019111 UCB INC 06/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019111s022lbl.pdf#page=25
Tysabri Natalizumab VIAL; SINGLE-USE 125104 BIOGEN IDEC 04/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf#page=30
Ultracet Acetaminophen; Tramadol Hydrochloride TABLET;ORAL 021123 JANSSEN PHARMS 09/18/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021123s014lbl.pdf#page=45
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
Vimovo Esomeprazole Magnesium; Naproxen TABLET, DELAYED RELEASE;ORAL 022511 HORIZON 06/07/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022511s023lbl.pdf#page=38
Viramune Nevirapine TABLET;ORAL 020636 BOEHRINGER INGELHEIM 09/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020636s050,020933s040lbl.pdf#page=19
Viramune Nevirapine SUSPENSION;ORAL 020933 BOEHRINGER INGELHEIM 09/24/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020636s048,020933s038lbl.pdf#page=19
Xenazine Tetrabenazine TABLET;ORAL 021894 VALEANT PHARMS NORTH 09/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021894s013lbl.pdf#page=24
Xigduo XR Dapagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649 ASTRAZENECA AB 10/26/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf#page=40
Xultophy 100/3.6 Insulin Degludec; Liraglutide SOLUTION;SUBCUTANEOUS 208583 NOVO NORDISK INC 12/12/2017 http://www.fda.gov/downloads/Drugs/DrugSafety/ucm530717.pdf
Xyrem Sodium Oxybate SOLUTION;ORAL 021196 JAZZ PHARMS 10/26/2018 http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s027lbl.pdf#page=22
Zinbryta Daclizumab INJECTABLE;INJECTION 761029 BIOGEN 11/01/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf#page=24
Zoloft Sertraline Hydrochloride CONCENTRATE;ORAL 020990 PFIZER 12/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019839s091lbl.pdf#page=27
Zorvolex Diclofenac CAPSULE;ORAL 204592 IROKO PHARMS LLC 05/09/2016 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372061.pdf
Zydelig Idelalisib TABLET;ORAL 205858 GILEAD SCIENCES INC 10/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205858s011lbl.pdf#page=1

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