Drugs@FDA: FDA Approved Drug Products

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All Approvals
October 2018

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on October 19, 2018.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2018 SEYSARA
NDA #209521
ORIG-1 SARECYCLINE ALLERGAN INC 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 PFIZER 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 PFIZER Labeling Approval
10/02/2018 NOXIVENT
ANDA #207141
ORIG-1 NITRIC OXIDE PRAXAIR DISTRIBUTION Approval
10/02/2018 NUZYRA
NDA #209816
ORIG-1 OMADACYCLINE PARATEK PHARMS INC Type 1 - New Molecular Entity Approval
10/02/2018 NUZYRA
NDA #209817
ORIG-1 OMADACYCLINE 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 INC 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 USA INC 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 LAKE Approval
10/03/2018 ROFLUMILAST
ANDA #208180
ORIG-1 ROFLUMILAST MICRO LABS LTD Tentative Approval
10/03/2018 ROFLUMILAST
ANDA #208236
ORIG-1 ROFLUMILAST BRECKENRIDGE PHARM Approval
10/03/2018 INGENOL MEBUTATE
ANDA #209018
ORIG-1 INGENOL MEBUTATE PERRIGO UK FINCO Tentative Approval
10/03/2018 ROPIVACAINE HYDROCHLORIDE
ANDA #210102
ORIG-1 ROPIVACAINE HYDROCHLORIDE GLAND PHARMA LTD Tentative 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 CSPC OUYI PHARM CO Approval
10/04/2018 LITHIUM CARBONATE
NDA #017812
SUPPL-31 LITHIUM CARBONATE WEST-WARD PHARMS INT Labeling Approval
10/04/2018 LITHIUM CITRATE
NDA #018421
SUPPL-31 LITHIUM CITRATE WEST-WARD PHARMS INT Labeling Approval
10/04/2018 LITHIUM CARBONATE
NDA #018558
SUPPL-26 LITHIUM CARBONATE WEST-WARD PHARMS INT 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 PHARM 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 NOVARTIS PHARMS Labeling Approval
10/05/2018 PYLERA
NDA #050786
SUPPL-19 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE ALLERGAN SALES LLC 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 MICRO LABS Approval
10/05/2018 COLESEVELAM HYDROCHLORIDE
ANDA #209038
ORIG-1 COLESEVELAM HYDROCHLORIDE ALKEM LABS LTD Approval
10/05/2018 JEMDEL
NDA #209355
ORIG-1 HALOBETASOL PROPIONATE DOW PHARM Type 3 - New Dosage Form Tentative Approval
10/05/2018 COLESEVELAM HYDROCHLORIDE
ANDA #210889
ORIG-1 COLESEVELAM HYDROCHLORIDE DR REDDYS LABS LTD Approval
10/05/2018 TEGSEDI
NDA #211172
ORIG-1 INOTERSEN IONIS PHARMS INC Type 1 - New Molecular Entity Approval
10/05/2018 REVCOVI
BLA #761092
ORIG-1 ELAPEGADEMASE-LVLR LEADIANT BIOSCI INC Approval
10/09/2018 BENAZEPRIL HYDROCHLORIDE
ANDA #078848
SUPPL-4 BENAZEPRIL HYDROCHLORIDE ZYDUS PHARMS USA Labeling Approval
10/09/2018 ADAPALENE
ANDA #091314
SUPPL-5 ADAPALENE GLENMARK GENERICS Labeling Tentative Approval
10/09/2018 BIMATOPROST
ANDA #203051
ORIG-1 BIMATOPROST HI-TECH PHARMACAL Approval
10/09/2018 AZITHROMYCIN
ANDA #203412
ORIG-1 AZITHROMYCIN HAINAN POLY PHARM Approval
10/09/2018 PARICALCITOL
ANDA #205982
ORIG-1 PARICALCITOL AUROBINDO PHARMA LTD Approval
10/09/2018 DOFETILIDE
ANDA #208519
ORIG-1 DOFETILIDE PAR PHARM INC 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 PHARMA GLOBAL 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 LURASIDONE HYDROCHLORIDE
ANDA #208031
ORIG-1 LURASIDONE HYDROCHLORIDE LUPIN LTD Tentative Approval
10/10/2018 LINAGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA #208449
ORIG-1 LINAGLIPTIN; METFORMIN HYDROCHLORIDE ZYDUS PHARMS USA INC Tentative Approval
10/10/2018 ASPIRIN AND DIPYRIDAMOLE
ANDA #209048
ORIG-1 ASPIRIN; DIPYRIDAMOLE DR REDDYS LABS LTD Approval
10/10/2018 PANTOPRAZOLE SODIUM
NDA #209463
SUPPL-5 PANTOPRAZOLE SODIUM EXELA PHARMA SCS LLC 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 PHARMA GLOBAL 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 MERCK SHARP DOHME Labeling Approval
10/12/2018 HYZAAR
NDA #020387
SUPPL-63 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM MERCK SHARP DOHME 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 NOVEL LABS INC Approval
10/12/2018 OMEPRAZOLE
ANDA #207891
ORIG-1 OMEPRAZOLE SUN PHARM INDS LTD Approval
10/12/2018 TICAGRELOR
ANDA #208575
ORIG-1 TICAGRELOR HISUN PHARM HANGZHOU Tentative Approval
10/12/2018 ARYMO ER
NDA #208603
SUPPL-1 MORPHINE SULFATE EGALET Efficacy Approval
10/12/2018 LEVOTHYROXINE SODIUM
ANDA #208749
ORIG-1 LEVOTHYROXINE SODIUM MAIA PHARMS INC Tentative Approval
10/12/2018 METFORMIN HYDROCHLORIDE
ANDA #208999
ORIG-1 METFORMIN HYDROCHLORIDE SUNSHINE LAKE Approval
10/12/2018 PIMECROLIMUS
ANDA #209345
ORIG-1 PIMECROLIMUS ACTAVIS LABS UT INC Tentative 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 G AND W LABS INC 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 EYEPOINT PHARMS Type 5 - New Formulation or New Manufacturer Approval
10/12/2018 CHLORTHALIDONE
ANDA #210742
ORIG-1 CHLORTHALIDONE APPCO PHARMA LLC 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 UPSHER-SMITH LABS Approval
10/12/2018 MIFEPRISTONE
ANDA #211436
ORIG-1 MIFEPRISTONE TEVA PHARMS USA Tentative 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 INC Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078579
SUPPL-4 LEVOFLOXACIN HOSPIRA INC 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 AUROBINDO PHARMA LTD Labeling Approval
10/15/2018 LEVOFLOXACIN
ANDA #202328
SUPPL-8 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/15/2018 VANCOMYCIN HYDROCHLORIDE
ANDA #204360
ORIG-1 VANCOMYCIN HYDROCHLORIDE HIKMA FARMACEUTICA 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 AUROBINDO PHARMA LTD Labeling Approval
10/15/2018 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #206919
SUPPL-3 LEVOFLOXACIN AUROBINDO PHARMA LTD Labeling Approval
10/15/2018 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
ANDA #207194
ORIG-1 BENZOYL PEROXIDE;CLINDAMYCIN PHOSPHATE TOLMAR Tentative Approval
10/15/2018 CLOBETASOL PROPIONATE
ANDA #211074
ORIG-1 CLOBETASOL PROPIONATE ZYDUS PHARMS USA INC 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 PHARMS INC Approval
10/16/2018 OPSUMIT
NDA #204410
SUPPL-10 MACITENTAN ACTELION PHARMS LTD 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 INGENUS PHARMS LLC 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 INVATECH PHARMA 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 PHARMS CO 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 PHARM CO 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 TELIGENT PHARMA INC Approval
10/16/2018 COLCHICINE
ANDA #211519
ORIG-1 COLCHICINE ZYDUS PHARMS USA INC Tentative Approval
10/16/2018 TALZENNA
NDA #211651
ORIG-1 TALAZOPARIB PFIZER INC Type 1 - New Molecular Entity 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 VISINE-A
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 TYMLOS
NDA #208743
SUPPL-3 ABALOPARATIDE RADIUS HEALTH INC Efficacy Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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