Drugs@FDA: FDA Approved Drug Products

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All Approvals
June 2017

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 June 25, 2017.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2017 SAMSCA
NDA #022275
SUPPL-15 TOLVAPTAN OTSUKA AMERICA PHARM Labeling Approval
06/01/2017 CEFPROZIL
ANDA #065327
SUPPL-1 CEFPROZIL APOTEX INC Labeling Approval
06/01/2017 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070765
SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE FRONTIDA BIOPHARM Labeling Approval
06/01/2017 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070766
SUPPL-19 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE FRONTIDA BIOPHARM Labeling Approval
06/01/2017 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #075618
SUPPL-25 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE HIKMA INTL PHARMS Labeling Approval
06/01/2017 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #076236
SUPPL-8 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE BARR Manufacturing (CMC) Tentative Approval
06/01/2017 OXYCODONE HYDROCHLORIDE
ANDA #090895
SUPPL-8 OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
06/01/2017 OXYCODONE HYDROCHLORIDE
ANDA #091313
SUPPL-5 OXYCODONE HYDROCHLORIDE MAYNE PHARMA INC Labeling Approval
06/01/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #201013
SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE AUROLIFE PHARMA LLC Labeling Approval
06/01/2017 LANSOPRAZOLE
ANDA #202176
SUPPL-3 LANSOPRAZOLE WOCKHARDT USA Labeling Approval
06/01/2017 LANSOPRAZOLE
ANDA #202176
SUPPL-6 LANSOPRAZOLE WOCKHARDT USA Labeling Approval
06/01/2017 MIRTAZAPINE
ANDA #205798
ORIG-1 MIRTAZAPINE ZYDUS PHARMS USA INC Approval
06/01/2017 LEVOFLOXACIN
ANDA #205968
ORIG-1 LEVOFLOXACIN ZYDUS PHARMS USA INC Approval
06/02/2017 NADOLOL
ANDA #208832
ORIG-1 NADOLOL AMNEAL PHARMS CO Approval
06/05/2017 MESALAMINE
ANDA #091640
ORIG-1 MESALAMINE ZYDUS PHARMS USA INC Approval
06/05/2017 NPLATE
BLA #125268
SUPPL-160 ROMIPLOSTIM AMGEN Approval
06/05/2017 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203460
SUPPL-5 MIDAZOLAM HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/05/2017 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203460
SUPPL-6 MIDAZOLAM HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/05/2017 CYANOCOBALAMIN
ANDA #204829
ORIG-1 CYANOCOBALAMIN MYLAN LABS LTD Approval
06/05/2017 LITHIUM CARBONATE
ANDA #205663
ORIG-1 LITHIUM CARBONATE UNIQUE PHARM LABS Approval
06/05/2017 ENTACAPONE
ANDA #207210
ORIG-1 ENTACAPONE MACLEODS PHARMS LTD Approval
06/05/2017 ARISTADA
NDA #207533
SUPPL-4 ARIPIPRAZOLE LAUROXIL ALKERMES INC Efficacy Approval
06/05/2017 BUTALBITAL AND ACETAMINOPHEN
ANDA #207635
ORIG-1 ACETAMINOPHEN; BUTALBITAL TEDOR PHARMA INC Approval
06/05/2017 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #209170
ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL ACCORD HLTHCARE Approval
06/06/2017 HUMALOG
NDA #020563
SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
06/06/2017 HUMALOG KWIKPEN
NDA #020563
SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
06/06/2017 HUMALOG PEN
NDA #020563
SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Labeling Approval
06/06/2017 LEFLUNOMIDE
ANDA #077087
SUPPL-13 LEFLUNOMIDE SANDOZ Labeling Approval
06/06/2017 HUMALOG KWIKPEN
NDA #205747
SUPPL-10 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Labeling Approval
06/06/2017 GLEOLAN
NDA #208630
ORIG-1 AMINOLEVULINIC ACID HYDROCHLORIDE NX DEVELOPMENT Type 3 - New Dosage Form Approval
06/07/2017 NORVIR
NDA #020659
SUPPL-67 RITONAVIR ABBVIE Labeling Approval
06/07/2017 NORVIR
NDA #022417
SUPPL-19 RITONAVIR ABBVIE Labeling Approval
06/07/2017 DUEXIS
NDA #022519
SUPPL-11 FAMOTIDINE; IBUPROFEN HORIZON PHARMA Labeling Approval
06/07/2017 ORENITRAM
NDA #203496
SUPPL-7 TREPROSTINIL DIOLAMINE UNITED THERAP Labeling Approval
06/07/2017 BEPOTASTINE BESILATE
ANDA #206080
ORIG-1 BEPOTASTINE BESILATE SANDOZ INC Tentative Approval
06/07/2017 AMANTADINE HYDROCHLORIDE
ANDA #209047
ORIG-1 AMANTADINE HYDROCHLORIDE STRIDES PHARMA Approval
06/07/2017 NORVIR
NDA #209512
ORIG-1 RITONAVIR ABBVIE INC Type 3 - New Dosage Form Approval
06/08/2017 LO/OVRAL-28
NDA #017802
SUPPL-29 ETHINYL ESTRADIOL; NORGESTREL WYETH PHARMS Labeling Approval
06/08/2017 MIRENA
NDA #021225
SUPPL-38 LEVONORGESTREL BAYER HLTHCARE Efficacy Approval
06/08/2017 TRUVADA
NDA #021752
SUPPL-52 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD REMS Approval
06/08/2017 CLONIDINE HYDROCHLORIDE
ANDA #071783
SUPPL-17 CLONIDINE HYDROCHLORIDE CHARTWELL MOLECULES Labeling Approval
06/08/2017 CLONIDINE HYDROCHLORIDE
ANDA #071784
SUPPL-17 CLONIDINE HYDROCHLORIDE CHARTWELL MOLECULES Labeling Approval
06/08/2017 CLONIDINE HYDROCHLORIDE
ANDA #071785
SUPPL-19 CLONIDINE HYDROCHLORIDE CHARTWELL MOLECULES Labeling Approval
06/08/2017 GABAPENTIN
ANDA #076403
SUPPL-2 GABAPENTIN ACELLA PHARMS LLC Labeling Approval
06/08/2017 SCANDONEST PLAIN
ANDA #088387
SUPPL-35 MEPIVACAINE HYDROCHLORIDE DEPROCO Manufacturing (CMC) Approval
06/08/2017 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351
ORIG-2 HYDROCHLOROTHIAZIDE; IRBESARTAN WEST-WARD PHARMS INT Approval
06/08/2017 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894
ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Approval
06/08/2017 DILTIAZEM HYDROCHLORIDE
ANDA #203023
ORIG-1 DILTIAZEM HYDROCHLORIDE SUN PHARM INDS LTD Approval
06/08/2017 ASENAPINE
ANDA #206098
ORIG-1 ASENAPINE ALEMBIC PHARMS LTD Tentative Approval
06/08/2017 NYSTATIN
ANDA #208581
ORIG-1 NYSTATIN NESHER PHARMS Approval
06/08/2017 CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE
ANDA #209014
ORIG-1 CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE AUROBINDO PHARMA LTD Tentative Approval
06/08/2017 SILIQ
BLA #761032
SUPPL-1 BRODALUMAB VALEANT LUXEMBOURG Approval
06/09/2017 THALOMID
NDA #020785
SUPPL-63 THALIDOMIDE CELGENE REMS Approval
06/09/2017 CUBICIN
NDA #021572
SUPPL-59 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
06/09/2017 CUBICIN RF
NDA #021572
SUPPL-59 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
06/09/2017 VELCADE
NDA #021602
SUPPL-43 BORTEZOMIB MILLENNIUM PHARMS Labeling Approval
06/09/2017 BIAXIN
NDA #050662
SUPPL-58 CLARITHROMYCIN ABBVIE Labeling Approval
06/09/2017 BIAXIN
NDA #050698
SUPPL-38 CLARITHROMYCIN ABBVIE Labeling Approval
06/09/2017 BIAXIN XL
NDA #050775
SUPPL-26 CLARITHROMYCIN ABBVIE Labeling Approval
06/09/2017 MEGESTROL ACETATE
ANDA #203960
ORIG-1 MEGESTROL ACETATE HI-TECH PHARMACAL Approval
06/09/2017 MEMANTINE HYDROCHLORIDE
ANDA #205784
ORIG-1 MEMANTINE HYDROCHLORIDE ANCHEN PHARMS Approval
06/09/2017 HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
ANDA #206891
ORIG-1 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE ACELLA PHARMS LLC Approval
06/09/2017 EVEROLIMUS
ANDA #207934
ORIG-1 EVEROLIMUS PAR PHARM INC Tentative Approval
06/09/2017 SPRITAM
NDA #207958
SUPPL-4 LEVETIRACETAM APRECIA PHARMS CO Labeling Approval
06/09/2017 PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #209008
ORIG-1 PSEUDOEPHEDRINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
06/09/2017 AMANTADINE HYDROCHLORIDE
ANDA #209035
ORIG-1 AMANTADINE HYDROCHLORIDE STRIDES PHARMA Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #077285
SUPPL-34 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
06/12/2017 EZETIMIBE
ANDA #078724
ORIG-1 EZETIMIBE TEVA PHARMS USA Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #090325
SUPPL-13 BUPROPION HYDROCHLORIDE MYLAN Labeling Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #090942
SUPPL-12 BUPROPION HYDROCHLORIDE MYLAN Labeling Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #090942
SUPPL-13 BUPROPION HYDROCHLORIDE MYLAN Labeling Approval
06/12/2017 INTRON A
BLA #103132
SUPPL-5195 INTERFERON ALFA-2B SCHERING Approval
06/12/2017 EZETIMIBE
ANDA #200831
ORIG-1 EZETIMIBE WATSON LABS INC Approval
06/12/2017 ADVIL
NDA #201803
SUPPL-8 IBUPROFEN SODIUM PFIZER CONS HLTHCARE Labeling Approval
06/12/2017 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543
SUPPL-10 LEVETIRACETAM HQ SPECIALITY PHARMA Labeling Approval
06/12/2017 EZETIMIBE
ANDA #203931
ORIG-1 EZETIMIBE SANDOZ INC Approval
06/12/2017 OXYCODONE HYDROCHLORIDE
ANDA #204021
ORIG-1 OXYCODONE HYDROCHLORIDE NOVEL LABS INC Approval
06/12/2017 EZETIMIBE
ANDA #204331
ORIG-1 EZETIMIBE ZYDUS PHARMS USA INC Approval
06/12/2017 SAXAGLIPTIN
ANDA #205994
ORIG-1 SAXAGLIPTIN GLENMARK PHARMS Tentative Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #206556
SUPPL-3 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/12/2017 BENDAMUSTINE HYDROCHLORIDE
ANDA #207149
ORIG-1 BENDAMUSTINE HYDROCHLORIDE WOCKHARDT USA Tentative Approval
06/12/2017 EZETIMIBE
ANDA #207311
ORIG-1 EZETIMIBE OHM LABS INC Approval
06/12/2017 EZETIMIBE
ANDA #208332
ORIG-1 EZETIMIBE APOTEX INC Approval
06/12/2017 ITRACONAZOLE
ANDA #208591
ORIG-1 ITRACONAZOLE ALKEM LABS LTD Approval
06/12/2017 EZETIMIBE
ANDA #208803
ORIG-1 EZETIMIBE AMNEAL PHARMS CO Approval
06/12/2017 AMANTADINE HYDROCHLORIDE
ANDA #209171
ORIG-1 AMANTADINE HYDROCHLORIDE HERITAGE PHARMA Approval
06/13/2017 VERMOX
NDA #017481
SUPPL-47 MEBENDAZOLE JANSSEN PHARMS Labeling Approval
06/13/2017 SULAR
NDA #020356
SUPPL-27 NISOLDIPINE COVIS PHARMA BV Labeling Approval
06/13/2017 ZIDOVUDINE
ANDA #077981
SUPPL-24 ZIDOVUDINE CIPLA LTD Labeling Approval
06/13/2017 ZIDOVUDINE
ANDA #077981
SUPPL-25 ZIDOVUDINE CIPLA LTD Labeling Approval
06/13/2017 OMEPRAZOLE
ANDA #204661
ORIG-1 OMEPRAZOLE TEVA PHARMS USA Approval
06/13/2017 INCRUSE ELLIPTA
NDA #205382
SUPPL-6 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Labeling Approval
06/13/2017 ACYCLOVIR SODIUM
ANDA #206606
ORIG-1 ACYCLOVIR SODIUM ZYDUS PHARMS USA INC Approval
06/13/2017 SEVELAMER CARBONATE
ANDA #207624
ORIG-1 SEVELAMER CARBONATE AUROBINDO PHARMA LTD Approval
06/14/2017 DYSPORT
BLA #125274
SUPPL-109 abobotulinumtoxinA IPSEN BIOPHARM LTD Approval
06/14/2017 CALCITRIOL
ANDA #203289
ORIG-1 CALCITRIOL AMNEAL PHARMS Approval
06/14/2017 PREZCOBIX
NDA #205395
SUPPL-4 COBICISTAT; DARUNAVIR ETHANOLATE JANSSEN PRODS Labeling Approval
06/14/2017 DOXYCYCLINE HYCLATE
ANDA #208765
ORIG-1 DOXYCYCLINE HYCLATE MAYNE PHARMA INC Approval
06/15/2017 ZOLOFT
NDA #019839
SUPPL-88 SERTRALINE HYDROCHLORIDE PFIZER Labeling Approval
06/15/2017 ZOLOFT
NDA #020990
SUPPL-46 SERTRALINE HYDROCHLORIDE PFIZER Labeling Approval
06/15/2017 KALETRA
NDA #021226
SUPPL-45 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
06/15/2017 KALETRA
NDA #021251
SUPPL-54 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
06/15/2017 VFEND
NDA #021266
SUPPL-41 VORICONAZOLE PF PRISM CV Labeling Approval
06/15/2017 VFEND
NDA #021267
SUPPL-53 VORICONAZOLE PF PRISM CV Labeling Approval
06/15/2017 VFEND
NDA #021630
SUPPL-31 VORICONAZOLE PF PRISM CV Labeling Approval
06/15/2017 KALETRA
NDA #021906
SUPPL-49 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
06/15/2017 INVEGA SUSTENNA
NDA #022264
SUPPL-23 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
06/15/2017 METAXALONE
ANDA #203695
ORIG-1 METAXALONE ACTAVIS LABS FL INC Approval
06/15/2017 AUROVELA 24 FE
ANDA #207504
ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA LTD Approval
06/15/2017 SYMJEPI
NDA #207534
ORIG-1 EPINEPHRINE ADAMIS PHARMACEUTICALS CORP Type 5 - New Formulation or New Manufacturer Approval
06/15/2017 AUROVELA FE 1.5/30
ANDA #207580
ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA LTD Approval
06/15/2017 CALCIUM GLUCONATE
NDA #208418
ORIG-1 CALCIUM GLUCONATE FRESENIUS KABI USA Type 7 - Drug Already Marketed without Approved NDA Approval
06/15/2017 GLYCOPYRROLATE
ANDA #208973
ORIG-1 GLYCOPYRROLATE AMNEAL PHARMS CO Approval
06/15/2017 AMANTADINE HYDROCHLORIDE
ANDA #209221
ORIG-1 AMANTADINE HYDROCHLORIDE LANNETT HOLDINGS INC Approval
06/16/2017 ADDYI
NDA #022526
SUPPL-4 FLIBANSERIN SPROUT PHARMS REMS Approval
06/16/2017 SYNERCID
NDA #050747
SUPPL-15 QUINUPRISTIN; DALFOPRISTIN KING PHARMS Labeling Approval
06/16/2017 SYNERCID
NDA #050748
SUPPL-14 DALFOPRISTIN; QUINUPRISTIN KING PHARMS Labeling Approval
06/16/2017 PROPRANOLOL HYDROCHLORIDE
ANDA #070690
SUPPL-21 PROPRANOLOL HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
06/16/2017 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #076914
SUPPL-4 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE WATSON LABS Labeling Approval
06/16/2017 LAMOTRIGINE
ANDA #078947
SUPPL-22 LAMOTRIGINE TORRENT PHARMS Labeling Approval
06/16/2017 LAMOTRIGINE
ANDA #078947
SUPPL-23 LAMOTRIGINE TORRENT PHARMS Labeling Approval
06/16/2017 OXYCODONE AND ACETAMINOPHEN
ANDA #201972
SUPPL-7 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
06/16/2017 SKLICE
NDA #202736
SUPPL-3 IVERMECTIN ARBOR PHARMS LLC Labeling Approval
06/16/2017 TAFINLAR
NDA #202806
SUPPL-7 DABRAFENIB MESYLATE NOVARTIS PHARMS CORP Labeling Approval
06/16/2017 DIFLUNISAL
ANDA #203547
ORIG-1 DIFLUNISAL ZYDUS PHARMS USA INC Approval
06/16/2017 NIACIN
ANDA #203899
ORIG-1 NIACIN LANNETT Approval
06/16/2017 NEURACEQ
NDA #204677
SUPPL-14 FLORBETABEN F-18 PIRAMAL IMAGING Labeling Approval
06/16/2017 OLANZAPINE
ANDA #204866
ORIG-1 OLANZAPINE HIKMA PHARMS LLC Approval
06/16/2017 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #205872
ORIG-1 CISATRACURIUM BESYLATE ACCORD HLTHCARE Approval
06/16/2017 CISATRACURIUM BESYLATE
ANDA #205873
ORIG-1 CISATRACURIUM BESYLATE ACCORD HLTHCARE Approval
06/16/2017 FELBAMATE
ANDA #206314
ORIG-1 FELBAMATE TARO PHARM Approval
06/16/2017 ELETRIPTAN HYDROBROMIDE
ANDA #206409
ORIG-1 ELETRIPTAN HYDROBROMIDE ZYDUS PHARMS USA INC Approval
06/16/2017 XADAGO
NDA #207145
SUPPL-1 SAFINAMIDE MESYLATE US WORLDMEDS LLC Labeling Approval
06/16/2017 AUROVELA FE 1/20
ANDA #207505
ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA LTD Approval
06/16/2017 AUROVELA 1/20
ANDA #207506
ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA LTD Approval
06/16/2017 TESTOSTERONE CYPIONATE
ANDA #207742
ORIG-1 TESTOSTERONE CYPIONATE LUITPOLD PHARMS INC Approval
06/16/2017 HER STYLE
ANDA #207976
SUPPL-1 LEVONORGESTREL NOVAST LABS LTD Labeling Approval
06/16/2017 HER STYLE
ANDA #207976
SUPPL-2 LEVONORGESTREL NOVAST LABS LTD Labeling Approval
06/16/2017 LINAGLIPTIN
ANDA #208415
ORIG-1 LINAGLIPTIN AUROBINDO PHARMA LTD Tentative Approval
06/16/2017 DARZALEX
BLA #761036
SUPPL-5 DARATUMUMAB JANSSEN BIOTECH Approval
06/17/2017 ABSORICA
NDA #021951
SUPPL-10 ISOTRETINOIN RANBAXY REMS Approval
06/17/2017 AMNESTEEM
ANDA #075945
SUPPL-34 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
06/17/2017 CLARAVIS
ANDA #076135
SUPPL-38 ISOTRETINOIN TEVA PHARMS USA REMS Approval
06/17/2017 CLARAVIS
ANDA #076356
SUPPL-35 ISOTRETINOIN TEVA PHARMS USA REMS Approval
06/17/2017 MYORISAN
ANDA #076485
SUPPL-15 ISOTRETINOIN DOUGLAS PHARMS REMS Approval
06/17/2017 ZENATANE
ANDA #202099
SUPPL-9 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
06/19/2017 PREZISTA
NDA #021976
SUPPL-45 DARUNAVIR ETHANOLATE JANSSEN PRODS Labeling Approval
06/19/2017 TACLONEX
NDA #022185
SUPPL-25 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
06/19/2017 PREZISTA
NDA #202895
SUPPL-20 DARUNAVIR ETHANOLATE JANSSEN PRODS Labeling Approval
06/19/2017 DANTROLENE SODIUM
ANDA #204762
ORIG-1 DANTROLENE SODIUM HIKMA PHARMS LLC Approval
06/19/2017 COTEMPLA XR-ODT
NDA #205489
ORIG-1 METHYLPHENIDATE NEOS THERAP INC Type 3 - New Dosage Form Approval
06/19/2017 AZITHROMYCIN
ANDA #207566
ORIG-1 AZITHROMYCIN CSPC Ouyi Pharmaceutical Co. Ltd. Tentative Approval
06/19/2017 BAXDELA
NDA #208610
ORIG-1 DELAFLOXACIN MELINTA THERAPEUTICS INC Type 1 - New Molecular Entity Approval
06/19/2017 BAXDELA
NDA #208611
ORIG-1 DELAFLOXACIN MELINTA THERAPEUTICS INC Type 1 - New Molecular Entity Approval
06/20/2017 MYDAYIS
NDA #022063
ORIG-1 MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE SHIRE DEV LLC Type 3 - New Dosage Form Approval
06/20/2017 ACETAZOLAMIDE SODIUM
ANDA #205358
ORIG-1 ACETAZOLAMIDE SODIUM PAR STERILE PRODUCTS Approval
06/20/2017 PIROXICAM
ANDA #206136
ORIG-1 PIROXICAM PII Approval
06/20/2017 LIDOCAINE
ANDA #206297
SUPPL-3 LIDOCAINE AMNEAL PHARMS Manufacturing (CMC) Approval
06/20/2017 PAROXETINE MESYLATE
ANDA #207139
ORIG-1 PAROXETINE MESYLATE ACTAVIS LABS FL INC Approval
06/20/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207171
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE LANNETT HOLDINGS INC Approval
06/20/2017 METRONIDAZOLE
ANDA #208681
ORIG-1 METRONIDAZOLE ORIT LABS LLC Approval
06/20/2017 CANDESARTAN CILEXETIL
ANDA #209119
ORIG-1 CANDESARTAN CILEXETIL ALEMBIC PHARMS LTD Approval
06/20/2017 SOLIFENACIN SUCCINATE
ANDA #209239
ORIG-1 SOLIFENACIN SUCCINATE GLENMARK PHARMS Tentative Approval
06/21/2017 DARAPRIM
NDA #008578
SUPPL-20 PYRIMETHAMINE TURING PHARMS LLC Labeling Approval
06/21/2017 CHILDREN'S ADVIL
NDA #020589
SUPPL-35 IBUPROFEN PFIZER Labeling Approval
06/21/2017 CHILDREN'S ADVIL-FLAVORED
NDA #020589
SUPPL-35 IBUPROFEN PFIZER Labeling Approval
06/21/2017 ESTRACE
ANDA #086069
SUPPL-23 ESTRADIOL ALLERGAN SALES LLC Labeling Approval
06/21/2017 GRANIX
BLA #125294
SUPPL-42 TBO-FILGRASTIM SICOR BIOTECH Approval
06/21/2017 SYNRIBO
NDA #203585
SUPPL-5 OMACETAXINE MEPESUCCINATE TEVA PHARMS INTL Labeling Approval
06/21/2017 IMATINIB MESYLATE
ANDA #204644
ORIG-1 IMATINIB MESYLATE MYLAN PHARMS INC Approval
06/21/2017 AMANTADINE HYDROCHLORIDE
ANDA #208966
ORIG-1 AMANTADINE HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
06/21/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209036
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ABHAI LLC Approval
06/21/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209037
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ABHAI LLC Approval
06/22/2017 PRIMAQUINE
NDA #008316
SUPPL-23 PRIMAQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
06/22/2017 SIMPONI
BLA #125289
SUPPL-133 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
06/22/2017 TAFINLAR
NDA #202806
SUPPL-6 DABRAFENIB MESYLATE NOVARTIS PHARMS CORP Efficacy Approval
06/22/2017 MEKINIST
NDA #204114
SUPPL-5 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS PHARMS CORP Efficacy Approval
06/22/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207172
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE LANNETT HOLDINGS INC Approval
06/22/2017 AMANTADINE HYDROCHLORIDE
ANDA #208107
SUPPL-2 AMANTADINE HYDROCHLORIDE WATSON LABS INC Manufacturing (CMC) Approval
06/22/2017 RITUXAN HYCELA
BLA #761064
ORIG-1 HYALURONIDASE;RITUXIMAB GENENTECH INC Approval
06/22/2017 RITUXAN HYCELA
BLA #761064
SUPPL-1 HYALURONIDASE;RITUXIMAB GENENTECH INC Approval
06/23/2017 BEVYXXA
NDA #208383
ORIG-1 BETRIXABAN PORTOLA PHARMA INC Type 1 - New Molecular Entity 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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