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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2018

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on April 29, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2018 SEYSARA
NDA #209521		 ORIG-1 SARECYCLINE HYDROCHLORIDE ALMIRALL Type 1 - New Molecular Entity Approval
10/01/2018 DESVENLAFAXINE SUCCINATE
ANDA #210014		 ORIG-1 DESVENLAFAXINE SUCCINATE YICHANG HUMANWELL Approval
10/02/2018 ADVIL
NDA #018989		 SUPPL-90 IBUPROFEN HALEON US HOLDINGS Labeling Approval
10/02/2018 CHEMET
NDA #019998		 SUPPL-21 SUCCIMER RECORDATI RARE Labeling Approval
10/02/2018 CHILDREN'S MOTRIN
NDA #020601		 SUPPL-21 IBUPROFEN J AND J CONSUMER INC Labeling Approval
10/02/2018 JUNIOR STRENGTH MOTRIN
NDA #020601		 SUPPL-21 IBUPROFEN J AND J CONSUMER INC Labeling Approval
10/02/2018 ADVIL PM
NDA #021394		 SUPPL-26 DIPHENHYDRAMINE CITRATE; IBUPROFEN HALEON US HOLDINGS Labeling Approval
10/02/2018 NOXIVENT
ANDA #207141		 ORIG-1 NITRIC OXIDE LINDE GAS EQUIP Approval
10/02/2018 NUZYRA
NDA #209816		 ORIG-1 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Type 1 - New Molecular Entity Approval
10/02/2018 NUZYRA
NDA #209817		 ORIG-1 OMADACYCLINE TOSYLATE PARATEK PHARMS INC Type 1 - New Molecular Entity Approval
10/03/2018 CLARITIN
NDA #019658		 SUPPL-54 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
10/03/2018 CLARITIN HIVES RELIEF
NDA #019658		 SUPPL-54 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
10/03/2018 IONSYS
NDA #021338		 SUPPL-10 FENTANYL HYDROCHLORIDE THE MEDICINES CO REMS Approval
10/03/2018 CYTARABINE
ANDA #072945		 SUPPL-20 CYTARABINE HOSPIRA Manufacturing (CMC) Approval
10/03/2018 CYTARABINE
ANDA #072945		 SUPPL-22 CYTARABINE HOSPIRA Labeling Approval
10/03/2018 RANITIDINE HYDROCHLORIDE
ANDA #075167		 SUPPL-13 RANITIDINE HYDROCHLORIDE APOTEX Labeling Approval
10/03/2018 CYTARABINE
ANDA #075383		 SUPPL-15 CYTARABINE HOSPIRA Labeling Approval
10/03/2018 ENBREL
BLA #103795		 SUPPL-5569 ETANERCEPT IMMUNEX Approval
10/03/2018 EXEMESTANE
ANDA #202602		 ORIG-1 EXEMESTANE ZYDUS PHARMS Approval
10/03/2018 VANCOMYCIN HYDROCHLORIDE
ANDA #206616		 ORIG-1 VANCOMYCIN HYDROCHLORIDE HIKMA PHARMS Approval
10/03/2018 ENTACAPONE
ANDA #206669		 ORIG-1 ENTACAPONE SUNSHINE Approval
10/03/2018 ROFLUMILAST
ANDA #208236		 ORIG-1 ROFLUMILAST BRECKENRIDGE Approval
10/03/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #210139		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE WES PHARMA INC Approval
10/03/2018 PRAZOSIN HYDROCHLORIDE
ANDA #210971		 ORIG-1 PRAZOSIN HYDROCHLORIDE NOVITIUM PHARMA Approval
10/03/2018 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #211088		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE RISING Approval
10/04/2018 LITHIUM CARBONATE
NDA #017812		 SUPPL-31 LITHIUM CARBONATE HIKMA Labeling Approval
10/04/2018 LITHIUM CITRATE
NDA #018421		 SUPPL-31 LITHIUM CITRATE HIKMA Labeling Approval
10/04/2018 LITHIUM CARBONATE
NDA #018558		 SUPPL-26 LITHIUM CARBONATE HIKMA Labeling Approval
10/04/2018 VFEND
NDA #021630		 SUPPL-33 VORICONAZOLE PF PRISM CV Labeling Approval
10/04/2018 CLOBETASOL PROPIONATE
ANDA #208779		 ORIG-1 CLOBETASOL PROPIONATE TARO Approval
10/04/2018 NOREPINEPHRINE BITARTRATE
ANDA #211242		 ORIG-1 NOREPINEPHRINE BITARTRATE MYLAN LABS LTD Approval
10/04/2018 HEMLIBRA
BLA #761083		 SUPPL-2 EMICIZUMAB GENENTECH INC Approval
10/04/2018 HEMLIBRA
BLA #761083		 SUPPL-4 EMICIZUMAB GENENTECH INC Approval
10/05/2018 TAXOTERE
NDA #020449		 SUPPL-79 DOCETAXEL SANOFI AVENTIS US Labeling Approval
10/05/2018 TOBI
NDA #050753		 SUPPL-22 TOBRAMYCIN MYLAN SPECIALITY LP Labeling Approval
10/05/2018 PYLERA
NDA #050786		 SUPPL-19 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE LABS JUVISE Labeling Approval
10/05/2018 STIOLTO RESPIMAT
NDA #206756		 SUPPL-9 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Efficacy Approval
10/05/2018 METHAZOLAMIDE
ANDA #207438		 ORIG-1 METHAZOLAMIDE BAUSCH AND LOMB INC Approval
10/05/2018 COLESEVELAM HYDROCHLORIDE
ANDA #209038		 ORIG-1 COLESEVELAM HYDROCHLORIDE ALKEM LABS LTD Approval
10/05/2018 TRIAMCINOLONE ACETONIDE
ANDA #209852		 ORIG-1 TRIAMCINOLONE ACETONIDE TEVA PHARMS USA Approval
10/05/2018 COLESEVELAM HYDROCHLORIDE
ANDA #210889		 ORIG-1 COLESEVELAM HYDROCHLORIDE DR REDDYS Approval
10/05/2018 TEGSEDI
NDA #211172		 ORIG-1 INOTERSEN SODIUM AKCEA THERAPS Type 1 - New Molecular Entity Approval
10/05/2018 REVCOVI
BLA #761092		 ORIG-1 ELAPEGADEMASE-LVLR CHIESI USA INC Approval
10/09/2018 BENAZEPRIL HYDROCHLORIDE
ANDA #078848		 SUPPL-4 BENAZEPRIL HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
10/09/2018 BIMATOPROST
ANDA #203051		 ORIG-1 BIMATOPROST HIKMA Approval
10/09/2018 AZITHROMYCIN
ANDA #203412		 ORIG-1 AZITHROMYCIN SLATE RUN PHARMA Approval
10/09/2018 PARICALCITOL
ANDA #205982		 ORIG-1 PARICALCITOL EUGIA PHARMA Approval
10/09/2018 DOFETILIDE
ANDA #208519		 ORIG-1 DOFETILIDE STRIDES PHARMA Approval
10/09/2018 AZITHROMYCIN
ANDA #209201		 ORIG-1 AZITHROMYCIN AUROBINDO PHARMA LTD Approval
10/09/2018 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #210279		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE ADARE PHARMS INC Approval
10/09/2018 DOFETILIDE
ANDA #210466		 ORIG-1 DOFETILIDE SUN PHARM Approval
10/09/2018 CEFIXIME
ANDA #210574		 ORIG-1 CEFIXIME ALKEM LABS LTD Approval
10/09/2018 SILIQ
BLA #761032		 SUPPL-5 BRODALUMAB VALEANT LUXEMBOURG Approval
10/10/2018 ZYDELIG
NDA #205858		 SUPPL-13 IDELALISIB GILEAD SCIENCES INC Labeling Approval
10/10/2018 ASPIRIN AND DIPYRIDAMOLE
ANDA #209048		 ORIG-1 ASPIRIN; DIPYRIDAMOLE DR REDDYS Approval
10/10/2018 PANTOPRAZOLE SODIUM
NDA #209463		 SUPPL-5 PANTOPRAZOLE SODIUM HIKMA Labeling Approval
10/10/2018 SPINRAZA
NDA #209531		 SUPPL-5 NUSINERSEN SODIUM BIOGEN IDEC Labeling Approval
10/11/2018 PLAVIX
NDA #020839		 SUPPL-69 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Labeling Approval
10/11/2018 CHILDREN'S ZYRTEC ALLERGY
NDA #022155		 SUPPL-15 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
10/11/2018 CHILDREN'S ZYRTEC HIVES RELIEF
NDA #022155		 SUPPL-15 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
10/11/2018 XARELTO
NDA #202439		 SUPPL-25 RIVAROXABAN JANSSEN PHARMS Efficacy Approval
10/11/2018 EXONDYS 51
NDA #206488		 SUPPL-9 ETEPLIRSEN SAREPTA THERAPS INC Labeling Approval
10/11/2018 CINACALCET HYDROCHLORIDE
ANDA #207008		 ORIG-1 CINACALCET HYDROCHLORIDE SUN PHARM Approval
10/11/2018 ATOVAQUONE
ANDA #210692		 ORIG-1 ATOVAQUONE HETERO LABS LTD III Approval
10/12/2018 PRINIVIL
NDA #019558		 SUPPL-62 LISINOPRIL MERCK Labeling Approval
10/12/2018 COZAAR
NDA #020386		 SUPPL-62 LOSARTAN POTASSIUM ORGANON Labeling Approval
10/12/2018 HYZAAR
NDA #020387		 SUPPL-63 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM ORGANON Labeling Approval
10/12/2018 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-38 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
NDA #020734		 SUPPL-34 AMINO ACIDS; DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
10/12/2018 MIRALAX
NDA #022015		 SUPPL-34 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
10/12/2018 CAPRELSA
NDA #022405		 SUPPL-14 VANDETANIB GENZYME CORP Efficacy Approval
10/12/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #201278		 SUPPL-7 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
10/12/2018 PERIOGARD
ANDA #203212		 SUPPL-1 CHLORHEXIDINE GLUCONATE COLGATE-PALMOLIVE CO Manufacturing (CMC) Approval
10/12/2018 SILDENAFIL CITRATE
ANDA #206401		 ORIG-1 SILDENAFIL CITRATE AJANTA PHARMA LTD Approval
10/12/2018 TESTOSTERONE
ANDA #206998		 ORIG-1 TESTOSTERONE AMNEAL PHARMS LLC Tentative Approval
10/12/2018 TRIAMCINOLONE ACETONIDE
ANDA #207365		 ORIG-1 TRIAMCINOLONE ACETONIDE CHARTWELL RX Approval
10/12/2018 OMEPRAZOLE
ANDA #207891		 ORIG-1 OMEPRAZOLE SUN PHARM Approval
10/12/2018 ARYMO ER
NDA #208603		 SUPPL-1 MORPHINE SULFATE ZYLA Efficacy Approval
10/12/2018 METFORMIN HYDROCHLORIDE
ANDA #208999		 ORIG-1 METFORMIN HYDROCHLORIDE SUNSHINE Approval
10/12/2018 MIRABEGRON
ANDA #209413		 ORIG-1 MIRABEGRON AUROBINDO PHARMA LTD Tentative Approval
10/12/2018 ALOGLIPTIN
ANDA #210172		 ORIG-1 ALOGLIPTIN ALEMBIC PHARMS LTD Tentative Approval
10/12/2018 BETAMETHASONE DIPROPIONATE
ANDA #210217		 ORIG-1 BETAMETHASONE DIPROPIONATE COSETTE Approval
10/12/2018 MEDROXYPROGESTERONE ACETATE
ANDA #210227		 ORIG-1 MEDROXYPROGESTERONE ACETATE MYLAN LABS LTD Approval
10/12/2018 YUTIQ
NDA #210331		 ORIG-1 FLUOCINOLONE ACETONIDE ALIMERA SCIENCES INC Type 5 - New Formulation or New Manufacturer Approval
10/12/2018 CHLORTHALIDONE
ANDA #210742		 ORIG-1 CHLORTHALIDONE APPCO Approval
10/12/2018 HYDROCORTISONE VALERATE
ANDA #211129		 ORIG-1 HYDROCORTISONE VALERATE GLENMARK PHARMS LTD Approval
10/12/2018 CLONIDINE HYDROCHLORIDE
ANDA #211433		 ORIG-1 CLONIDINE HYDROCHLORIDE BLUEPHARMA INDUSTRIA Approval
10/15/2018 CIPROFLOXACIN
ANDA #076717		 SUPPL-3 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/15/2018 CIPROFLOXACIN
ANDA #076717		 SUPPL-4 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5%
ANDA #076757		 SUPPL-5 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5%
ANDA #076757		 SUPPL-6 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/15/2018 CIPROFLOXACIN
ANDA #077245		 SUPPL-19 CIPROFLOXACIN HOSPIRA Labeling Approval
10/15/2018 CIPROFLOXACIN
ANDA #077245		 SUPPL-21 CIPROFLOXACIN HOSPIRA Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #077753		 SUPPL-15 CIPROFLOXACIN HOSPIRA Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #077753		 SUPPL-18 CIPROFLOXACIN HOSPIRA Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078024		 SUPPL-21 CIPROFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/15/2018 CIPROFLOXACIN
ANDA #078062		 SUPPL-15 CIPROFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078431		 SUPPL-6 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/15/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078431		 SUPPL-7 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078579		 SUPPL-2 LEVOFLOXACIN HOSPIRA Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078579		 SUPPL-4 LEVOFLOXACIN HOSPIRA Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 SUPPL-9 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 SUPPL-15 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/15/2018 LEVOFLOXACIN
ANDA #091436		 SUPPL-4 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/15/2018 LEVOFLOXACIN
ANDA #091436		 SUPPL-7 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/15/2018 LEVOFLOXACIN
ANDA #202328		 SUPPL-7 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
10/15/2018 LEVOFLOXACIN
ANDA #202328		 SUPPL-8 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
10/15/2018 VANCOMYCIN HYDROCHLORIDE
ANDA #204360		 ORIG-1 VANCOMYCIN HYDROCHLORIDE HIKMA Approval
10/15/2018 LILETTA
NDA #206229		 SUPPL-7 LEVONORGESTREL MEDICINES360 Efficacy Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206919		 SUPPL-2 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206919		 SUPPL-3 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
10/15/2018 CLOBETASOL PROPIONATE
ANDA #211074		 ORIG-1 CLOBETASOL PROPIONATE ZYDUS PHARMS Approval
10/16/2018 HUMIRA
BLA #125057		 SUPPL-409 ADALIMUMAB ABBVIE INC Approval
10/16/2018 CINACALCET HYDROCHLORIDE
ANDA #203422		 ORIG-1 CINACALCET HYDROCHLORIDE MYLAN Approval
10/16/2018 OPSUMIT
NDA #204410		 SUPPL-10 MACITENTAN ACTELION Labeling Approval
10/16/2018 RILUZOLE
ANDA #204430		 ORIG-1 RILUZOLE DAITO PHARMS CO LTD Approval
10/16/2018 OXALIPLATIN
ANDA #207562		 ORIG-1 OXALIPLATIN NOVAST LABS Approval
10/16/2018 ROSUVASTATIN CALCIUM
ANDA #208850		 ORIG-1 ROSUVASTATIN CALCIUM AMNEAL PHARMS CO Approval
10/16/2018 CYPROHEPTADINE HYDROCHLORIDE
ANDA #209108		 ORIG-1 CYPROHEPTADINE HYDROCHLORIDE ELYSIUM Approval
10/16/2018 FESOTERODINE FUMARATE
ANDA #209783		 ORIG-1 FESOTERODINE FUMARATE TORRENT PHARMS LLC Tentative Approval
10/16/2018 CARMUSTINE
ANDA #211229		 ORIG-1 CARMUSTINE AMNEAL Approval
10/16/2018 URSODIOL
ANDA #211301		 ORIG-1 URSODIOL AMNEAL PHARMS CO Approval
10/16/2018 DULOXETINE HYDROCHLORIDE
ANDA #211310		 ORIG-1 DULOXETINE HYDROCHLORIDE CSPC OUYI Approval
10/16/2018 GABAPENTIN
ANDA #211314		 ORIG-1 GABAPENTIN STRIDES PHARMA Approval
10/16/2018 BUPROPION HYDROCHLORIDE
ANDA #211347		 ORIG-1 BUPROPION HYDROCHLORIDE YICHANG HUMANWELL Approval
10/16/2018 FLUOCINONIDE
ANDA #211410		 ORIG-1 FLUOCINONIDE ENCUBE Approval
10/16/2018 TALZENNA
NDA #211651		 ORIG-1 TALAZOPARIB TOSYLATE PFIZER Type 1 - New Molecular Entity Approval
10/16/2018 HELIUM, USP
NDA #212539		 ORIG-1 HELIUM MATHESON TRI-GAS INC Medical Gas Approval
10/17/2018 METRONIDAZOLE
NDA #018764		 SUPPL-42 METRONIDAZOLE WATSON LABS Labeling Approval
10/17/2018 CORDARONE
NDA #018972		 SUPPL-54 AMIODARONE HYDROCHLORIDE WYETH PHARMS Labeling Approval
10/17/2018 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-46 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Labeling Approval
10/17/2018 VISINE
NDA #020485		 SUPPL-13 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE JOHNSON AND JOHNSON Efficacy Approval
10/17/2018 PERFOROMIST
NDA #022007		 SUPPL-14 FORMOTEROL FUMARATE MYLAN SPECLT Labeling Approval
10/17/2018 HERCEPTIN
BLA #103792		 SUPPL-5347 TRASTUZUMAB GENENTECH Approval
10/17/2018 LANSOPRAZOLE
ANDA #203964		 ORIG-1 LANSOPRAZOLE BRECKENRIDGE Approval
10/17/2018 TYMLOS
NDA #208743		 SUPPL-3 ABALOPARATIDE RADIUS Efficacy Approval
10/17/2018 ADAPALENE AND BENZOYL PEROXIDE
ANDA #209148		 ORIG-1 ADAPALENE; BENZOYL PEROXIDE TARO Approval
10/17/2018 CEFAZOLIN SODIUM
ANDA #209217		 ORIG-1 CEFAZOLIN SODIUM QILU Approval
10/17/2018 CEFTRIAXONE
ANDA #209218		 ORIG-1 CEFTRIAXONE SODIUM QILU Approval
10/17/2018 ISOPROTERENOL HYDROCHLORIDE
ANDA #210576		 ORIG-1 ISOPROTERENOL HYDROCHLORIDE AMNEAL Approval
10/18/2018 DILANTIN-125
NDA #008762		 SUPPL-62 PHENYTOIN VIATRIS Labeling Approval
10/18/2018 DILANTIN-30
NDA #008762		 SUPPL-62 PHENYTOIN VIATRIS Labeling Approval
10/18/2018 DESYREL
NDA #018207		 SUPPL-33 TRAZODONE HYDROCHLORIDE PRAGMA Labeling Approval
10/18/2018 CIPRO
NDA #019537		 SUPPL-88 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
10/18/2018 CIPRO
NDA #019847		 SUPPL-59 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
10/18/2018 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-68 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
10/18/2018 LEVAQUIN
NDA #020634		 SUPPL-70 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
10/18/2018 CIPRO
NDA #020780		 SUPPL-45 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
10/18/2018 AVELOX
NDA #021085		 SUPPL-64 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
10/18/2018 LAMISIL AT
NDA #021124		 SUPPL-16 TERBINAFINE HYDROCHLORIDE KARO HLTHCARE Labeling Approval
10/18/2018 FACTIVE
NDA #021158		 SUPPL-25 GEMIFLOXACIN MESYLATE LG CHEM LTD Labeling Approval
10/18/2018 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
NDA #021277		 SUPPL-60 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
10/18/2018 CIPRO XR
NDA #021473		 SUPPL-39 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
10/18/2018 OFLOXACIN
ANDA #076093		 SUPPL-10 OFLOXACIN LARKEN LABS Labeling Approval
10/18/2018 OFLOXACIN
ANDA #076182		 SUPPL-16 OFLOXACIN TEVA Labeling Approval
10/18/2018 CIPROFLOXACIN
ANDA #076717		 SUPPL-5 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/18/2018 CIPROFLOXACIN IN DEXTROSE 5%
ANDA #076757		 SUPPL-7 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/18/2018 OFLOXACIN
ANDA #077098		 SUPPL-11 OFLOXACIN DR REDDYS LABS LTD Labeling Approval
10/18/2018 CIPROFLOXACIN
ANDA #077245		 SUPPL-22 CIPROFLOXACIN HOSPIRA Labeling Approval
10/18/2018 CIPROFLOXACIN EXTENDED RELEASE
ANDA #077701		 SUPPL-14 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
10/18/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #077753		 SUPPL-19 CIPROFLOXACIN HOSPIRA Labeling Approval
10/18/2018 CIPROFLOXACIN
ANDA #077782		 SUPPL-17 CIPROFLOXACIN DR REDDYS Labeling Approval
10/18/2018 CIPROFLOXACIN EXTENDED RELEASE
ANDA #077809		 SUPPL-6 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE ANI PHARMS Labeling Approval
10/18/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078024		 SUPPL-25 CIPROFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/18/2018 CIPROFLOXACIN
ANDA #078062		 SUPPL-16 CIPROFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/18/2018 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078166		 SUPPL-13 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
10/18/2018 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078183		 SUPPL-19 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE RISING Labeling Approval
10/18/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078252		 SUPPL-29 CIPROFLOXACIN INFORLIFE Labeling Approval
10/18/2018 CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078431		 SUPPL-8 CIPROFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/18/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078579		 SUPPL-5 LEVOFLOXACIN HOSPIRA Labeling Approval
10/18/2018 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078712		 SUPPL-5 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE FOSUN PHARMA Labeling Approval
10/18/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #090343		 SUPPL-26 LEVOFLOXACIN INFORLIFE Labeling Approval
10/18/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091375		 SUPPL-14 LEVOFLOXACIN HIKMA FARMACEUTICA Labeling Approval
10/18/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 SUPPL-16 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/18/2018 LEVOFLOXACIN
ANDA #091436		 SUPPL-8 LEVOFLOXACIN BAXTER HLTHCARE CORP Labeling Approval
10/18/2018 OFLOXACIN
ANDA #091656		 SUPPL-4 OFLOXACIN CADILA PHARMS LTD Labeling Approval
10/18/2018 LEVOFLOXACIN
ANDA #091678		 SUPPL-5 LEVOFLOXACIN NOVITIUM PHARMA Labeling Approval
10/18/2018 RITUXAN
BLA #103705		 SUPPL-5451 RITUXIMAB GENENTECH Approval
10/18/2018 REPATHA
BLA #125522		 SUPPL-17 EVOLOCUMAB AMGEN INC Approval
10/18/2018 LEVOFLOXACIN
ANDA #200560		 SUPPL-12 LEVOFLOXACIN MYLAN ASI Labeling Approval
10/18/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #200674		 SUPPL-6 LEVOFLOXACIN FRESENIUS KABI USA Labeling Approval
10/18/2018 LEVOFLOXACIN
ANDA #202328		 SUPPL-9 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
10/18/2018 LEVOFLOXACIN
ANDA #202590		 SUPPL-9 LEVOFLOXACIN AVET LIFESCIENCES Labeling Approval
10/18/2018 XELJANZ
NDA #203214		 SUPPL-20 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
10/18/2018 BOSULIF
NDA #203341		 SUPPL-15 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
10/18/2018 ICLUSIG
NDA #203469		 SUPPL-30 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
10/18/2018 CAPREOMYCIN SULFATE
ANDA #204796		 ORIG-1 CAPREOMYCIN SULFATE HISUN PHARM HANGZHOU Approval
10/18/2018 MOXIFLOXACIN HYDROCHLORIDE
NDA #205572		 SUPPL-4 MOXIFLOXACIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
10/18/2018 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
ANDA #205833		 SUPPL-3 MOXIFLOXACIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
10/18/2018 LEVOFLOXACIN
ANDA #205968		 SUPPL-2 LEVOFLOXACIN ZYDUS PHARMS Labeling Approval
10/18/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206919		 SUPPL-4 LEVOFLOXACIN EUGIA PHARMA Labeling Approval
10/18/2018 ACETAZOLAMIDE
ANDA #207659		 ORIG-1 ACETAZOLAMIDE ACCORD HLTHCARE Approval
10/18/2018 XELJANZ XR
NDA #208246		 SUPPL-6 TOFACITINIB CITRATE PFIZER Labeling Approval
10/18/2018 BAXDELA
NDA #208610		 SUPPL-5 DELAFLOXACIN MEGLUMINE MELINTA Labeling Approval
10/18/2018 BAXDELA
NDA #208611		 SUPPL-4 DELAFLOXACIN MEGLUMINE MELINTA Labeling Approval
10/18/2018 NOREPINEPHRINE BITARTRATE
ANDA #211359		 ORIG-1 NOREPINEPHRINE BITARTRATE SANDOZ Approval
10/19/2018 TRINTELLIX
NDA #204447		 SUPPL-17 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Efficacy Approval
10/19/2018 SAXENDA
NDA #206321		 SUPPL-7 LIRAGLUTIDE NOVO Efficacy Approval
10/19/2018 ADMELOG
BLA #209196		 SUPPL-1 INSULIN LISPRO SANOFI-AVENTIS US Approval
10/19/2018 ADMELOG SOLOSTAR
BLA #209196		 SUPPL-1 INSULIN LISPRO SANOFI-AVENTIS US Approval
10/19/2018 QMIIZ ODT
NDA #211210		 ORIG-1 MELOXICAM TERSERA Type 3 - New Dosage Form Approval
10/19/2018 KHAPZORY
NDA #211226		 ORIG-1 LEVOLEUCOVORIN ACROTECH BIOPHARMA Type 2 - New Active Ingredient Approval
10/19/2018 BAVENCIO
BLA #761049		 SUPPL-3 AVELUMAB EMD SERONO INC Approval
10/19/2018 DUPIXENT
BLA #761055		 SUPPL-7 DUPILUMAB REGENERON PHARMACEUTICALS Approval
10/22/2018 METOPIRONE
NDA #012911		 SUPPL-35 METYRAPONE HRA PHARMA Labeling Approval
10/22/2018 DDAVP
NDA #017922		 SUPPL-46 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
10/22/2018 DDAVP (NEEDS NO REFRIGERATION)
NDA #017922		 SUPPL-46 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
10/22/2018 METFORMIN HYDROCHLORIDE
ANDA #206145		 ORIG-1 METFORMIN HYDROCHLORIDE ALKEM LABS LTD Approval
10/22/2018 AZACITIDINE
NDA #208216		 SUPPL-2 AZACITIDINE ACTAVIS LLC Labeling Approval
10/22/2018 CLOBAZAM
ANDA #208785		 ORIG-1 CLOBAZAM HIKMA Approval
10/22/2018 CLOBAZAM
ANDA #208819		 ORIG-1 CLOBAZAM BIONPHARMA Approval
10/22/2018 CLOBAZAM
ANDA #208825		 ORIG-1 CLOBAZAM BIONPHARMA Approval
10/22/2018 CLOBAZAM
ANDA #209308		 ORIG-1 CLOBAZAM BRECKENRIDGE Approval
10/22/2018 CLOBAZAM
ANDA #209440		 ORIG-1 CLOBAZAM TARO Approval
10/22/2018 CLOBAZAM
ANDA #209687		 ORIG-1 CLOBAZAM UPSHER SMITH LABS Approval
10/22/2018 CLOBAZAM
ANDA #209715		 ORIG-1 CLOBAZAM HIKMA Approval
10/22/2018 CLOBAZAM
ANDA #209718		 ORIG-1 CLOBAZAM AMNEAL PHARMS CO Approval
10/22/2018 CLOBAZAM
ANDA #209795		 ORIG-1 CLOBAZAM HETERO LABS LTD III Approval
10/22/2018 CLOBAZAM
ANDA #209808		 ORIG-1 CLOBAZAM PIRAMAL HLTHCARE UK Approval
10/22/2018 CLOBAZAM
ANDA #210039		 ORIG-1 CLOBAZAM AMNEAL Approval
10/22/2018 CLOBAZAM
ANDA #210569		 ORIG-1 CLOBAZAM UPSHER SMITH LABS Approval
10/22/2018 CLOBAZAM
ANDA #211259		 ORIG-1 CLOBAZAM MYLAN Approval
10/22/2018 CLOBAZAM
ANDA #211449		 ORIG-1 CLOBAZAM ZYDUS PHARMS Approval
10/23/2018 FLOLAN
NDA #020444		 SUPPL-23 EPOPROSTENOL SODIUM GLAXOSMITHKLINE LLC Labeling Approval
10/23/2018 LAMOTRIGINE
ANDA #077783		 SUPPL-13 LAMOTRIGINE CHARTWELL MOLECULAR Labeling Approval
10/23/2018 LAMOTRIGINE
ANDA #077783		 SUPPL-14 LAMOTRIGINE CHARTWELL MOLECULAR Labeling Approval
10/23/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #201278		 SUPPL-9 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE RHODES PHARMS Labeling Approval
10/23/2018 SOVALDI
NDA #204671		 SUPPL-13 SOFOSBUVIR GILEAD SCIENCES INC Labeling Approval
10/23/2018 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #209726		 ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM AMNEAL PHARMS CO Approval
10/23/2018 DESOXIMETASONE
ANDA #209973		 ORIG-1 DESOXIMETASONE THE J MOLNER Approval
10/24/2018 ARALEN
NDA #006002		 SUPPL-45 CHLOROQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
10/24/2018 ARALEN HYDROCHLORIDE
NDA #006002		 SUPPL-45 CHLOROQUINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
10/24/2018 EDLUAR
NDA #021997		 SUPPL-8 ZOLPIDEM TARTRATE MYLAN SPECIALITY LP Labeling Approval
10/24/2018 IRBESARTAN
ANDA #202254		 SUPPL-21 IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
10/24/2018 DALFAMPRIDINE
ANDA #206646		 ORIG-1 DALFAMPRIDINE HIKMA Approval
10/24/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209958		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ALVOGEN Approval
10/24/2018 XOFLUZA
NDA #210854		 ORIG-1 BALOXAVIR MARBOXIL GENENTECH INC Type 1 - New Molecular Entity Approval
10/25/2018 TRACLEER
NDA #021290		 SUPPL-37 BOSENTAN ACTELION Labeling Approval
10/25/2018 AFREZZA
BLA #022472		 SUPPL-18 INSULIN RECOMBINANT HUMAN MANNKIND Approval
10/25/2018 INJECTAFER
NDA #203565		 SUPPL-8 FERRIC CARBOXYMALTOSE AM REGENT Labeling Approval
10/25/2018 TOUJEO MAX SOLOSTAR
BLA #206538		 SUPPL-10 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
10/25/2018 TOUJEO MAX SOLOSTAR
BLA #206538		 SUPPL-11 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
10/25/2018 TOUJEO SOLOSTAR
BLA #206538		 SUPPL-10 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
10/25/2018 TOUJEO SOLOSTAR
BLA #206538		 SUPPL-11 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
10/25/2018 AZITHROMYCIN
ANDA #208249		 ORIG-1 AZITHROMYCIN CSPC OUYI Approval
10/25/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #209276		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC Approval
10/25/2018 TRACLEER
NDA #209279		 SUPPL-2 BOSENTAN ACTELION Labeling Approval
10/25/2018 SEVELAMER CARBONATE
ANDA #210464		 ORIG-1 SEVELAMER CARBONATE DR REDDYS Approval
10/25/2018 FLUCINOLONE ACETONIDE
ANDA #210556		 ORIG-1 FLUOCINOLONE ACETONIDE GLENMARK PHARMS LTD Approval
10/25/2018 PROCHLORPERAZINE EDISYLATE
ANDA #210710		 ORIG-1 PROCHLORPERAZINE EDISYLATE MYLAN LABS LTD Approval
10/25/2018 GLYCOPYRROLATE
ANDA #210842		 ORIG-1 GLYCOPYRROLATE PIRAMAL CRITICAL Approval
10/26/2018 SUBUTEX
NDA #020732		 SUPPL-21 BUPRENORPHINE HYDROCHLORIDE INDIVIOR REMS Approval
10/26/2018 SUBOXONE
NDA #020733		 SUPPL-25 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
10/26/2018 DITROPAN XL
NDA #020897		 SUPPL-36 OXYBUTYNIN CHLORIDE JANSSEN PHARMS Labeling Approval
10/26/2018 XYREM
NDA #021196		 SUPPL-30 SODIUM OXYBATE JAZZ PHARMS Efficacy Approval
10/26/2018 SUBOXONE
NDA #022410		 SUPPL-35 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
10/26/2018 GILENYA
NDA #022527		 SUPPL-27 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
10/26/2018 CARISOPRODOL
ANDA #040792		 SUPPL-12 CARISOPRODOL AUROBINDO PHARMA Manufacturing (CMC) Approval
10/26/2018 JAKAFI
NDA #202192		 SUPPL-16 RUXOLITINIB PHOSPHATE INCYTE CORP Labeling Approval
10/26/2018 FARXIGA
NDA #202293		 SUPPL-17 DAPAGLIFLOZIN ASTRAZENECA AB Labeling Approval
10/26/2018 OSPHENA
NDA #203505		 SUPPL-14 OSPEMIFENE DUCHESNAY Labeling Approval
10/26/2018 INVOKANA
NDA #204042		 SUPPL-31 CANAGLIFLOZIN JANSSEN PHARMS Labeling Approval
10/26/2018 INVOKAMET
NDA #204353		 SUPPL-31 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
10/26/2018 JARDIANCE
NDA #204629		 SUPPL-18 EMPAGLIFLOZIN BOEHRINGER INGELHEIM Labeling Approval
10/26/2018 PENICILLIN G POTASSIUM
ANDA #205043		 ORIG-1 PENICILLIN G POTASSIUM ACS DOBFAR SPA Approval
10/26/2018 XIGDUO XR
NDA #205649		 SUPPL-10 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
10/26/2018 INVOKAMET XR
NDA #205879		 SUPPL-9 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
10/26/2018 GLYXAMBI
NDA #206073		 SUPPL-19 EMPAGLIFLOZIN; LINAGLIPTIN BOEHRINGER INGELHEIM Labeling Approval
10/26/2018 SYNJARDY
NDA #206111		 SUPPL-18 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
10/26/2018 METOPROLOL SUCCINATE
ANDA #207465		 ORIG-1 METOPROLOL SUCCINATE CIPLA Approval
10/26/2018 XTAMPZA ER
NDA #208090		 SUPPL-9 OXYCODONE COLLEGIUM PHARM INC Labeling Approval
10/26/2018 SYNJARDY XR
NDA #208658		 SUPPL-6 EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Labeling Approval
10/26/2018 QTERN
NDA #209091		 SUPPL-3 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
10/26/2018 TERIFLUNOMIDE
ANDA #209638		 ORIG-1 TERIFLUNOMIDE AUROBINDO PHARMA Approval
10/26/2018 STEGLATRO
NDA #209803		 SUPPL-1 ERTUGLIFLOZIN MSD SUB MERCK Labeling Approval
10/26/2018 STEGLUJAN
NDA #209805		 SUPPL-4 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
10/26/2018 SEGLUROMET
NDA #209806		 SUPPL-1 ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE MSD SUB MERCK Labeling Approval
10/26/2018 FLUOCINONIDE ACETONIDE
ANDA #210539		 ORIG-1 FLUOCINOLONE ACETONIDE GLENMARK PHARMS LTD Approval
10/26/2018 FELODIPINE
ANDA #210847		 ORIG-1 FELODIPINE YILING Approval
10/26/2018 PROGESTERONE
ANDA #211285		 ORIG-1 PROGESTERONE EUGIA PHARMA Approval
10/26/2018 CLOBETASOL PROPIONATE
ANDA #211348		 ORIG-1 CLOBETASOL PROPIONATE EPIC PHARMA LLC Approval
10/26/2018 ALBUTEROL SULFATE
ANDA #211397		 ORIG-1 ALBUTEROL SULFATE VIRTUS PHARM Approval
10/26/2018 QUETIAPINE FUMARATE
ANDA #211405		 ORIG-1 QUETIAPINE FUMARATE AMNEAL PHARMS Approval
10/26/2018 METHOCARBAMOL
ANDA #211504		 ORIG-1 METHOCARBAMOL GLAND PHARMA LTD Approval
10/26/2018 LIOTHYRONINE SODIUM
ANDA #211510		 ORIG-1 LIOTHYRONINE SODIUM TEVA PHARMS USA Approval
10/26/2018 EZETIMIBE
ANDA #211550		 ORIG-1 EZETIMIBE ACCORD HLTHCARE Approval
10/28/2018 BIJUVA
NDA #210132		 ORIG-1 ESTRADIOL; PROGESTERONE MAYNE PHARMA Type 4 - New Combination Approval
10/29/2018 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
NDA #020849		 SUPPL-24 AMINO ACIDS BAXTER HLTHCARE Labeling Approval
10/29/2018 PHOTREXA
NDA #203324		 SUPPL-7 RIBOFLAVIN 5'-PHOSPHATE GLAUKOS Manufacturing (CMC) Approval
10/29/2018 PHOTREXA VISCOUS IN DEXTRAN 20%
NDA #203324		 SUPPL-7 RIBOFLAVIN 5'-PHOSPHATE GLAUKOS Manufacturing (CMC) Approval
10/29/2018 METOPROLOL SUCCINATE
ANDA #203894		 SUPPL-3 METOPROLOL SUCCINATE ZYDUS PHARMS Manufacturing (CMC) Approval
10/29/2018 INVOKANA
NDA #204042		 SUPPL-27 CANAGLIFLOZIN JANSSEN PHARMS Efficacy Approval
10/29/2018 INVOKAMET
NDA #204353		 SUPPL-25 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
10/29/2018 CLOPIDOGREL BISULFATE
ANDA #204359		 SUPPL-6 CLOPIDOGREL BISULFATE RISING Manufacturing (CMC) Approval
10/29/2018 INVOKAMET XR
NDA #205879		 SUPPL-7 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
10/29/2018 MIDODRINE HYDROCHLORIDE
ANDA #207169		 ORIG-1 MIDODRINE HYDROCHLORIDE PAR PHARM INC Approval
10/29/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #207419		 SUPPL-3 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ASCENT PHARMS INC Manufacturing (CMC) Approval
10/29/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207509		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Approval
10/29/2018 CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #210906		 ORIG-1 CALCIUM GLUCONATE HQ SPCLT PHARMA Type 5 - New Formulation or New Manufacturer Approval
10/30/2018 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-67 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Manufacturing (CMC) Approval
10/30/2018 KEYTRUDA
BLA #125514		 SUPPL-41 PEMBROLIZUMAB MERCK SHARP DOHME Approval
10/30/2018 MUPIROCIN
ANDA #201587		 SUPPL-4 MUPIROCIN CALCIUM GLENMARK PHARMS INC Labeling Approval
10/30/2018 MUPIROCIN
ANDA #201587		 SUPPL-6 MUPIROCIN CALCIUM GLENMARK PHARMS INC Labeling Approval
10/30/2018 GLYCOPYRROLATE
ANDA #202675		 ORIG-2 GLYCOPYRROLATE AUROBINDO PHARMA Approval
10/30/2018 TYBOST
NDA #203094		 SUPPL-12 COBICISTAT GILEAD SCIENCES INC Efficacy Approval
10/30/2018 HYDRALAZINE HYDROCHLORIDE
ANDA #203845		 SUPPL-1 HYDRALAZINE HYDROCHLORIDE CADILA PHARMS LTD Labeling Approval
10/30/2018 HYDRALAZINE HYDROCHLORIDE
ANDA #203845		 SUPPL-2 HYDRALAZINE HYDROCHLORIDE CADILA PHARMS LTD Manufacturing (CMC) Approval
10/30/2018 URSODIOL
ANDA #211145		 ORIG-1 URSODIOL ZYDUS LIFESCIENCES Approval
10/30/2018 HYRIMOZ
BLA #761071		 ORIG-1 ADALIMUMAB-ADAZ SANDOZ INC Approval
10/31/2018 ALBENZA
NDA #020666		 SUPPL-11 ALBENDAZOLE IMPAX LABS INC Labeling Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-16 BUPRENORPHINE HYDROCHLORIDE HIKMA REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090279		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE RUBICON REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-16 BUPRENORPHINE HYDROCHLORIDE BARR REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-26 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090819		 SUPPL-15 BUPRENORPHINE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149		 SUPPL-13 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 SUPPL-26 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE MYLAN REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUN PHARM REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201760		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE SUN PHARM REMS Approval
10/31/2018 COMPLERA
NDA #202123		 SUPPL-29 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-19 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326		 SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE HIKMA REMS Approval
10/31/2018 ZUBSOLV
NDA #204242		 SUPPL-15 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE OREXO US INC REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431		 SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ETHYPHARM USA CORP REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE LANNETT CO INC REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205299		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DR REDDYS LABS SA REMS Approval
10/31/2018 BUNAVAIL
NDA #205637		 SUPPL-19 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205806		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DR REDDYS LABS SA REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207000		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SPECGX LLC REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #207276		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE RHODES PHARMS REMS Approval
10/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #207607		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE MYLAN TECHNOLOGIES REMS Approval
10/31/2018 CLOFARABINE
ANDA #207831		 ORIG-1 CLOFARABINE GLAND PHARMA LTD Approval
10/31/2018 XTRELUS
NDA #208085		 SUPPL-1 GUAIFENESIN; HYDROCODONE BITARTRATE ECI PHARMS LLC Labeling Approval
10/31/2018 ABIRATERONE ACETATE
ANDA #208339		 ORIG-1 ABIRATERONE ACETATE HIKMA Approval
10/31/2018 ODEFSEY
NDA #208351		 SUPPL-6 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
10/31/2018 ABIRATERONE ACETATE
ANDA #208432		 ORIG-1 ABIRATERONE ACETATE TEVA PHARMS USA Approval
10/31/2018 ABIRATERONE ACETATE
ANDA #208446		 ORIG-1 ABIRATERONE ACETATE MYLAN Approval
10/31/2018 ABIRATERONE ACETATE
ANDA #208453		 ORIG-1 ABIRATERONE ACETATE APOTEX Approval
10/31/2018 CLOMIPRAMINE HYDROCHLORIDE
ANDA #208632		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE AMNEAL PHARMS CO Approval
10/31/2018 VARDENAFIL HYDROCHLORIDE
ANDA #208960		 ORIG-1 VARDENAFIL HYDROCHLORIDE ZYDUS PHARMS Approval
10/31/2018 GLYCOPYRROLATE
ANDA #209024		 ORIG-1 GLYCOPYRROLATE FRESENIUS KABI USA Approval
10/31/2018 VARDENAFIL HYDROCHLORIDE
ANDA #209057		 ORIG-1 VARDENAFIL HYDROCHLORIDE CROSSMEDIKA SA Approval
10/31/2018 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #209587		 ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE LGM PHARMA Approval
10/31/2018 BUPROPION HYDROCHLORIDE
ANDA #210497		 ORIG-1 BUPROPION HYDROCHLORIDE ACCORD HLTHCARE Approval
10/31/2018 VARDENAFIL HYDROCHLORIDE
ANDA #210738		 ORIG-1 VARDENAFIL HYDROCHLORIDE STEVENS J Approval
10/31/2018 GLYCOPYRROLATE
ANDA #210927		 ORIG-1 GLYCOPYRROLATE PRINSTON INC Approval
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