Safety Labeling Change Orders

4/28/2023 NDA-019758 Clozaril (Clozapine) HERITAGE LIFE SCIENCES BARBADOS INC Archive 9/20/2021 NDA-018936 Prozac (Fluoxetine Hydrochloride) ELI LILLY AND COMPANY Archive 4/11/2019 NDA-022526 Addyi (Flibanserin) SPROUT PHARMACEUTICALS INC Archive 3/09/2018 NDA-020839 Plavix (Clopidogrel Bisulfate) SANOFI AVENTIS US LLC Archive 2/23/2017 ANDA-071212, ANDA-071173, ANDA-071172, ANDA-071157, ANDA-071156 Haloperidol FRONTIDA BIOPHANN INC Archive 2/23/2017 ANDA-089903, ANDA-089523 Prochlorperazine Edisylate WEST-WARD PHARMACEUTICALS CORP Archive 12/20/2016 ANDA-075523 Naloxone and Pentazocine SUN PHARMACEUTICAL INDUSTRIES, INC Archive 12/16/2016 ANDA-081002 Meperidine Hydrochloride WEST-WARD PHARMACEUTICAL CORP Archive 12/16/2016 ANDA-070765, ANDA-070766,
ANDA-070683 Amitriptyline Hydrochloride and Chlordiazepoxide,
Oxazepam FRONTIDA BIOPHARM INC Archive 12/16/2016 ANDA-070444, ANDA-070445 Flurazepam Hydrochloride PAR PHARMACEUTICAL INC Archive 12/16/2016 ANDA-075045, ANDA-075046 Butorphanol Tartrate WEST-WARD PHARMACEUTICALS CORP Archive 12/16/2016 ANDA-205001 Acetaminophen and Hydrocodone Bitartrate PAR PHARMACEUTICAL, INC Archive 12/16/2016 ANDA-089671, ANDA-089672 Acetaminophen and Codeine Phosphate FRONTIDA BIOPHARM INC Archive 11/08/2016 ANDA-040805 Hydroxyzine Hydrochloride HETERO USA, INC
U.S. AGENT FOR HETERO LABS LIMITED UNIT- III Archive 10/21/2016 ANDA-090387 Testosterone Cypionate WEST-WARD PHARMACEUTICAL CORP Archive 10/21/2016 ANDA-091244 Testosterone Cypionate WEST-WARD PHARMACEUTICAL CORP Archive 9/07/2016 NDA-022276 Nicardipine Hydrochloride EXELA PHARMA SCIENCES, LLC Archive 5/09/2016 ANDA-070088 Ibuprofen BASF CORPORATION Archive 5/09/2016 ANDA-074819,
ANDA-079093 Etodolac,
Nabumetone PROSAM LABS, LLC Archive 12/15/2014 NDA-050824 Omeclamox-Pak (Omeprazole, Amoxicillin, and Clarithromycin) GASTROENTERO-LOGIC, LLC Archive 9/18/2014 ANDA-078969 Granisetron Hydrochloride INC RESEARCH LLC Archive 9/09/2014 ANDA-086498, ANDA-086499, ANDA-086500, ANDA-086501, ANDA-086502, ANDA-086503, ANDA-083827 Amitriptyline Hydrochloride,
Imipramine Hydrochloride ALRA LABORATORIES, INC Archive 7/31/2014 NDA-009470 Xylocaine Viscous (Lidocaine Hydrochloride) FRESENIUS KABI USA LLC Archive 7/22/2014 ANDA-076015 Fluoxetine Hydrochloride PHARMACEUTICAL ASSOCIATES, INC Archive 7/22/2014 ANDA-040751, ANDA-040752, ANDA-040753 Imipramine Hydrochloride PROSAM LABS, LLC Archive 7/22/2014 ANDA-075525 Fluoxetine Hydrochloride HI-TECH PHARMACAL CO., INC Archive 7/22/2014 ANDA-071196,
ANDA-071258 Trazodone,
Trazodone Hydrochloride APOTEX INC Archive 7/03/2014 NDA-014694 Hexadrol (Dexamethasone Sodium Phospate) ORGANON USA INC Archive 6/03/2014 ANDA-088184, ANDA-088185 Hydroxyzine Hydrochloride FRESENIUS KABI USA, LLC Archive 6/03/2014 ANDA-040600, ANDA-040602, ANDA-040604 Hydroxyzine Hydrochloride MIKAH PHARMA LLC Archive 6/03/2014 ANDA-087014 Orgatrax (Hydroxyzine Hydrochloride) ORGANON USA INC Archive 10/24/2013 ANDA-040261 Acetaminophen, Butalbital, and Caffeine WEST-WARD PHARMACEUTICALS CORP Archive 10/24/2013 ANDA-087811 Phrenilin (Acetaminophen and Butalbital) KELLER AND HECKMAN LLP
U.S. AGENT FOR VALEANT INTERNATIONAL BERMUDA Archive 10/24/2013 ANDA-040864 Acetaminophen, Butalbital, and Caffeine MIRROR PHARMACEUTICALS LLC Archive 10/24/2013 ANDA-088831 Phrenilin Forte (Acetaminophen and Butalbital) KELLER AND HECKMAN LLP
U.S. AGENT FOR VALEANT INTERNATIONAL BERMUDA Archive 10/24/2013 ANDA-040336 Acetaminophen, Butalbital, and Caffeine WEST-WARD PHARMACEUTICALS CORP Archive 10/24/2013 ANDA-040688 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate WRASER PHARMACEUTICALS Archive 10/24/2013 ANDA-040883 Acetaminophen, Butalbital, and Caffeine MIRROR PHARMACEUTICALS LLC Archive 8/19/2013 ANDA-077417, ANDA-077809 Ciprofloxacin WATSON LABORATORIES, INC. - FLORIDA Archive 8/19/2013 ANDA-078712 Ciprofloxacin SANDOZ, INC Archive 5/10/2013 ANDA-088704 Triacin-C® Cough Syrup (Codeine Phosphate, Pseudoephedrine Hydrochloride, and Triprolidine Hydrochloride) CLINSMART LLC
U.S. AGENT FOR STI PHARMA LLC Archive 5/10/2013 ANDA-087006 Acetaminophen and Codeine Phosphate WOCKHARDT EU OPERATIONS (SWISS) AG Archive 5/10/2013 ANDA-040223 Acetaminophen and Codeine Phosphate BARR LABORATORIES, INC Archive 5/10/2013 ANDA-040441 Acetaminophen and Codeine Phosphate WATSON LABORATORIES, INC - FLORIDA Archive 5/10/2013 ANDA-040447, ANDA-040488 Acetaminophen and Codeine Phosphate WATSON LABORATORIES, INC - FLORIDA Archive 5/10/2013 ANDA-089997, ANDA-089998, ANDA-089999 Acetaminophen and Codeine Phosphate WATSON LABORATORIES, INC Archive 5/10/2013 ANDA-040688 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate WRASER PHARMACEUTICALS Archive 5/10/2013 ANDA-040701 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate BOCA PHARMACAL, INC. Archive 5/10/2013 ANDA-089671, ANDA-089672 Acetaminophen and Codeine Phosphate FRONTIDA BIOPHARM INC Archive 5/10/2013 ANDA-040443 Acetaminophen and Codeine Phosphate WATSON LABORATORIES, INC - FLORIDA Archive 4/11/2013 ANDA-073143, ANDA-074436 Cyclobenzaprine Hydrochloride WATSON LABORATORIES, INC Archive 4/11/2013 ANDA-072854 Cyclobenzaprine Hydrochloride SANDOZ, INC Archive 4/11/2013 ANDA-077209, ANDA-077291 Cyclobenzaprine Hydrochloride PROSAM LABS, LLC Archive 12/20/2010 NDA-021358 MultiHance (Gadobenate Dimeglumine) and MultiHance Multipack (Gadobenate Dimeglumine) BRACCO DIAGNOSTICS, INC Archive 11/02/2010 ANDA-074900, ANDA-074901 Atracurium Besylate BEDFORD LABORATORIES Archive 11/02/2010 ANDA-074944,
ANDA-074945 Atracurium Besylate WATSON PHARMACEUTICALS, INC Archive 11/02/2010 ANDA-090243 Vecuronium Bromide AKORN-STRIDES, LLC Archive 11/02/2010 ANDA-078562 Mivacurium Chloride PISGAH LABS, INC Archive 11/02/2010 ANDA-074334 Vecuronium WATSON PHARMACEUTICALS, INC Archive 11/02/2010 ANDA-075218 Vecuronium Bromide BAXTER HEALTHCARE CORPORATION Archive 6/02/2010 NDA-020692,
NDA-021077,
NDA-021254 Serevent Diskus (Salmeterol Xinafoate),
Advair Diskus (Fluticasone Propionate and Salmeterol), Advair HFA (Fluticasone Propionate and Salmeterol Xinafoate) GLAXOSMITHKLINE Archive 6/02/2010 NDA-021929 Symbicort pMDI (Budesonide and Formoterol Fumarate) ASTRAZENECA LP Archive 3/09/2010 NDA-019309 Vasotec (Enalapril Maleate) BIOVAIL LABORATORIES INTERNATIONAL SRL Archive 1/21/2010 NDA-006188 Propylthiouracil DAVA PHARMACEUTICALS, INC Archive 7/19/2009 NDA-020592, NDA-021253; NDA-021086 Zyprexa (Olanzapine), Zyprexa Zydis (Olanzapine) ELI LILLY AND COMPANY Archive 7/19/2009 NDA-021520 Symbyax (Fluoxetine and Olanzapine) ELI LILLY AND COMPANY Archive 7/30/2008 BLA-103234 Procrit (Epoetin Alfa) AMGEN, INCORPORATED Archive 7/30/2008 BLA-103951 Aranesp (Darbepoetin Alpha) AMGEN, INCORPORATED Archive

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