Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
January 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 December 09, 2019.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
01/02/2018 EXCEDRIN (MIGRAINE)
NDA #020802
SUPPL-32 ACETAMINOPHEN; ASPIRIN; CAFFEINE GLAXOSMITHKLINE CONS Labeling Approval
01/02/2018 DOXYCYCLINE HYCLATE
ANDA #062031
SUPPL-79 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
01/02/2018 DOXYCYCLINE HYCLATE
ANDA #062031
SUPPL-80 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
01/02/2018 DOXYCYCLINE HYCLATE
ANDA #062421
SUPPL-62 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
01/02/2018 DOXYCYCLINE HYCLATE
ANDA #062421
SUPPL-67 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
01/02/2018 DOXYCYCLINE HYCLATE
ANDA #062421
SUPPL-68 DOXYCYCLINE HYCLATE ACTAVIS LABS FL INC Labeling Approval
01/02/2018 INVOKAMET XR
NDA #205879
SUPPL-2 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
01/03/2018 TROKENDI XR
NDA #201635
SUPPL-18 TOPIRAMATE SUPERNUS PHARMS Labeling Approval
01/04/2018 PARNATE
NDA #012342
SUPPL-64 TRANYLCYPROMINE SULFATE CONCORDIA Labeling Approval
01/04/2018 NOXAFIL
NDA #022003
SUPPL-22 POSACONAZOLE SCHERING Labeling Approval
01/04/2018 PROLIA
BLA #125320
SUPPL-182 DENOSUMAB AMGEN Approval
01/04/2018 XGEVA
BLA #125320
SUPPL-182 DENOSUMAB AMGEN Approval
01/04/2018 DOCETAXEL
ANDA #204193
SUPPL-4 DOCETAXEL DR REDDYS LABS LTD Labeling Approval
01/04/2018 NOXAFIL
NDA #205053
SUPPL-6 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
01/04/2018 NOXAFIL
NDA #205596
SUPPL-5 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
01/05/2018 ERAXIS
NDA #021632
SUPPL-26 ANIDULAFUNGIN VICURON Labeling Approval
01/08/2018 COARTEM
NDA #022268
SUPPL-19 ARTEMETHER; LUMEFANTRINE NOVARTIS Labeling Approval
01/08/2018 RIFADIN
NDA #050420
SUPPL-77 RIFAMPIN SANOFI AVENTIS US Labeling Approval
01/08/2018 RIFADIN
NDA #050627
SUPPL-20 RIFAMPIN SANOFI AVENTIS US Labeling Approval
01/08/2018 RIFATER
NDA #050705
SUPPL-12 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
01/08/2018 TETRABENAZINE
ANDA #209284
ORIG-1 TETRABENAZINE DR REDDYS Approval
01/09/2018 UVADEX
NDA #020969
SUPPL-10 METHOXSALEN MALLINCKRODT HOSP Labeling Approval
01/09/2018 ACIPHEX
NDA #020973
SUPPL-38 RABEPRAZOLE SODIUM EISAI INC Labeling Approval
01/09/2018 OPDIVO
BLA #125554
SUPPL-35 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
01/09/2018 OPDIVO
BLA #125554
SUPPL-36 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
01/09/2018 OPDIVO
BLA #125554
SUPPL-37 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
01/09/2018 OPDIVO
BLA #125554
SUPPL-38 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
01/09/2018 OPDIVO
BLA #125554
SUPPL-39 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
01/09/2018 JEVTANA KIT
NDA #201023
SUPPL-21 CABAZITAXEL SANOFI AVENTIS US Labeling Approval
01/09/2018 OSELTAMIVIR PHOSPHATE
ANDA #208348
ORIG-1 OSELTAMIVIR PHOSPHATE LUPIN ATLANTIS Approval
01/09/2018 BALCOLTRA
NDA #208612
ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL AVION PHARMS Type 3 - New Dosage Form Approval
01/10/2018 CHG SCRUB
NDA #019258
SUPPL-26 CHLORHEXIDINE GLUCONATE ECOLAB Labeling Approval
01/10/2018 CIDA-STAT
NDA #019258
SUPPL-26 CHLORHEXIDINE GLUCONATE ECOLAB Labeling Approval
01/10/2018 AZACITIDINE
NDA #208216
SUPPL-1 AZACITIDINE ACTAVIS LLC Labeling Approval
01/10/2018 DUPIXENT
BLA #761055
SUPPL-5 DUPILUMAB REGENERON PHARMACEUTICALS Approval
01/11/2018 RAXIBACUMAB
BLA #125349
SUPPL-22 RAXIBACUMAB HUMAN GENOME SCIENCES INC. Approval
01/11/2018 ADEMPAS
NDA #204819
SUPPL-11 RIOCIGUAT BAYER HLTHCARE Efficacy Approval
01/12/2018 CLARITIN
NDA #019658
SUPPL-50 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
01/12/2018 CLARITIN HIVES RELIEF
NDA #019658
SUPPL-50 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
01/12/2018 RAPAMUNE
NDA #021083
SUPPL-62 SIROLIMUS PF PRISM CV Labeling Approval
01/12/2018 RAPAMUNE
NDA #021110
SUPPL-81 SIROLIMUS PF PRISM CV Labeling Approval
01/12/2018 TRISENOX
NDA #021248
SUPPL-15 ARSENIC TRIOXIDE CEPHALON Efficacy Approval
01/12/2018 ZORTRESS
NDA #021560
SUPPL-20 EVEROLIMUS NOVARTIS Labeling Approval
01/12/2018 ZORTRESS
NDA #021560
SUPPL-21 EVEROLIMUS NOVARTIS Labeling Approval
01/12/2018 GILOTRIF
NDA #201292
SUPPL-14 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Efficacy Approval
01/12/2018 COMETRIQ
NDA #203756
SUPPL-5 CABOZANTINIB S-MALATE EXELIXIS Labeling Approval
01/12/2018 LYNPARZA
NDA #208558
SUPPL-1 OLAPARIB ASTRAZENECA PHARMS Efficacy Approval
01/12/2018 SINUVA
NDA #209310
SUPPL-1 MOMETASONE FUROATE INTERSECT ENT INC Labeling Approval
01/12/2018 POTASSIUM CHLORIDE
ANDA #209688
ORIG-1 POTASSIUM CHLORIDE VITRUVIAS THERAP Approval
01/16/2018 ALEVE PM
NDA #205352
SUPPL-10 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
01/16/2018 REMIFENTANIL HYDROCHLORIDE
ANDA #206223
ORIG-1 REMIFENTANIL HYDROCHLORIDE FRESENIUS KABI USA Approval
01/16/2018 LIDOCAINE
ANDA #210256
ORIG-1 LIDOCAINE TEVA PHARMS USA Approval
01/17/2018 KYPROLIS
NDA #202714
SUPPL-17 CARFILZOMIB ONYX THERAP Efficacy Approval
01/17/2018 CABAZITAXEL INJECTION
NDA #207970
ORIG-1 CABAZITAXEL ACTAVIS LLC Type 5 - New Formulation or New Manufacturer Tentative Approval
01/17/2018 PERAMPANEL
ANDA #209801
ORIG-1 PERAMPANEL TEVA PHARMS USA INC Tentative Approval
01/17/2018 JULUCA
NDA #210192
SUPPL-1 DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE VIIV HLTHCARE Labeling Approval
01/17/2018 HYDROMORPHONE HYDROCHLORIDE
ANDA #210506
ORIG-1 HYDROMORPHONE HYDROCHLORIDE ASCENT PHARMS INC Approval
01/18/2018 MERREM
NDA #050706
SUPPL-39 MEROPENEM PFIZER Labeling Approval
01/18/2018 KYBELLA
NDA #206333
SUPPL-1 DEOXYCHOLIC ACID KYTHERA BIOPHARMS Labeling Approval
01/18/2018 TIGECYCLINE
NDA #208744
ORIG-1 TIGECYCLINE ACCORD HLTHCARE INC Type 5 - New Formulation or New Manufacturer Approval
01/19/2018 NASACORT ALLERGY 24 HOUR
NDA #020468
SUPPL-44 TRIAMCINOLONE ACETONIDE SANOFI AVENTIS US Labeling Approval
01/19/2018 MULTIHANCE
NDA #021357
SUPPL-14 GADOBENATE DIMEGLUMINE BRACCO Efficacy Approval
01/19/2018 MULTIHANCE MULTIPACK
NDA #021358
SUPPL-13 GADOBENATE DIMEGLUMINE BRACCO Efficacy Approval
01/19/2018 DOXORUBICIN HYDROCHLORIDE
ANDA #062921
SUPPL-26 DOXORUBICIN HYDROCHLORIDE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
01/19/2018 MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
NDA #202106
SUPPL-3 MEROPENEM B BRAUN MEDICAL INC Labeling Approval
01/19/2018 TICAGRELOR
ANDA #208505
ORIG-1 TICAGRELOR SANDOZ INC Tentative Approval
01/19/2018 DOCETAXEL
ANDA #209640
ORIG-1 DOCETAXEL AMNEAL Approval
01/19/2018 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #210375
ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE DR REDDYS LABS LTD Approval
01/22/2018 DIFLUCAN
NDA #019949
SUPPL-68 FLUCONAZOLE PFIZER Labeling Approval
01/22/2018 DIFLUCAN
NDA #020090
SUPPL-49 FLUCONAZOLE PFIZER Labeling Approval
01/22/2018 SPRIX
NDA #022382
SUPPL-18 KETOROLAC TROMETHAMINE ZYLA Labeling Approval
01/22/2018 ESTRADIOL
ANDA #210194
ORIG-1 ESTRADIOL PERRIGO UK FINCO Approval
01/23/2018 COPAXONE
NDA #020622
SUPPL-102 GLATIRAMER ACETATE TEVA PHARMS USA Labeling Approval
01/23/2018 DALIRESP
NDA #022522
SUPPL-9 ROFLUMILAST ASTRAZENECA PHARMS Efficacy Approval
01/23/2018 COSENTYX
BLA #125504
SUPPL-13 SECUKINUMAB NOVARTIS PHARMS CORP Approval
01/23/2018 ADAPALENE AND BENZOYL PEROXIDE
ANDA #205033
ORIG-1 ADAPALENE; BENZOYL PEROXIDE PERRIGO UK FINCO Approval
01/23/2018 LIQUID E-Z-PAQUE
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 READI-CAT 2
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 READI-CAT 2 SMOOTHIE
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 TAGITOL V
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 VARIBAR HONEY
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 VARIBAR NECTAR
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 VARIBAR THIN HONEY
NDA #208143
SUPPL-6 BARIUM SULFATE BRACCO Efficacy Approval
01/23/2018 BUMETANIDE
ANDA #209916
ORIG-1 BUMETANIDE UPSHER SMITH LABS Approval
01/23/2018 CELECOXIB
ANDA #210071
ORIG-1 CELECOXIB CSPC OUYI Approval
01/24/2018 DURAGESIC-100
NDA #019813
SUPPL-72 FENTANYL JANSSEN PHARMS Efficacy Approval
01/24/2018 DURAGESIC-100
NDA #019813
SUPPL-73 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
01/24/2018 DURAGESIC-12
NDA #019813
SUPPL-72 FENTANYL JANSSEN PHARMS Efficacy Approval
01/24/2018 DURAGESIC-12
NDA #019813
SUPPL-73 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
01/24/2018 DURAGESIC-25
NDA #019813
SUPPL-72 FENTANYL JANSSEN PHARMS Efficacy Approval
01/24/2018 DURAGESIC-25
NDA #019813
SUPPL-73 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
01/24/2018 DURAGESIC-37
NDA #019813
SUPPL-72 FENTANYL JANSSEN PHARMS Efficacy Approval
01/24/2018 DURAGESIC-37
NDA #019813
SUPPL-73 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
01/24/2018 DURAGESIC-50
NDA #019813
SUPPL-72 FENTANYL JANSSEN PHARMS Efficacy Approval
01/24/2018 DURAGESIC-50
NDA #019813
SUPPL-73 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
01/24/2018 DURAGESIC-75
NDA #019813
SUPPL-72 FENTANYL JANSSEN PHARMS Efficacy Approval
01/24/2018 DURAGESIC-75
NDA #019813
SUPPL-73 FENTANYL JANSSEN PHARMS Manufacturing (CMC) Approval
01/24/2018 BUSULFEX
NDA #020954
SUPPL-17 BUSULFAN OTSUKA PHARM Labeling Approval
01/24/2018 NITROSTAT
NDA #021134
SUPPL-10 NITROGLYCERIN PFIZER PHARMS Labeling Approval
01/24/2018 AVEED
NDA #022219
SUPPL-10 TESTOSTERONE UNDECANOATE ENDO PHARMS INC Labeling Approval
01/24/2018 RANITIDINE HYDROCHLORIDE
ANDA #076195
SUPPL-30 RANITIDINE HYDROCHLORIDE PERRIGO Manufacturing (CMC) Approval
01/24/2018 PROLIA
BLA #125320
SUPPL-185 DENOSUMAB AMGEN Approval
01/24/2018 XGEVA
BLA #125320
SUPPL-185 DENOSUMAB AMGEN Approval
01/24/2018 NEXIUM 24HR
NDA #204655
SUPPL-9 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Labeling Approval
01/24/2018 ADAPALENE AND BENZOYL PEROXIDE
ANDA #206959
ORIG-1 ADAPALENE; BENZOYL PEROXIDE TARO Approval
01/24/2018 ADAPALENE AND BENZOYL PEROXIDE
ANDA #206959
ORIG-2 ADAPALENE; BENZOYL PEROXIDE TARO Labeling Approval
01/24/2018 TRULANCE
NDA #208745
SUPPL-1 PLECANATIDE SALIX Efficacy Approval
01/24/2018 SYMPROIC
NDA #208854
SUPPL-2 NALDEMEDINE TOSYLATE BDSI Labeling Approval
01/25/2018 VIDEX
NDA #020156
SUPPL-53 DIDANOSINE BRISTOL-MYERS SQUIBB Labeling Approval
01/25/2018 VIDEX EC
NDA #021183
SUPPL-28 DIDANOSINE BRISTOL MYERS SQUIBB Labeling Approval
01/25/2018 PREZISTA
NDA #021976
SUPPL-47 DARUNAVIR JANSSEN PRODS Labeling Approval
01/25/2018 PYLERA
NDA #050786
SUPPL-17 BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE ALLERGAN Labeling Approval
01/25/2018 PREZISTA
NDA #202895
SUPPL-21 DARUNAVIR JANSSEN PRODS Labeling Approval
01/25/2018 PREZCOBIX
NDA #205395
SUPPL-6 COBICISTAT; DARUNAVIR JANSSEN PRODS Labeling Approval
01/25/2018 PREZCOBIX
NDA #205395
SUPPL-7 COBICISTAT; DARUNAVIR JANSSEN PRODS Labeling Approval
01/25/2018 LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
NDA #205493
ORIG-1 LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE MICRO LABS LTD Type 4 - New Combination Tentative Approval
01/25/2018 BUNAVAIL
NDA #205637
SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI Labeling Approval
01/25/2018 ORKAMBI
NDA #206038
SUPPL-7 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Efficacy Approval
01/25/2018 ARISTADA
NDA #207533
SUPPL-9 ARIPIPRAZOLE LAUROXIL ALKERMES INC Labeling Approval
01/26/2018 DILAUDID
NDA #019034
SUPPL-30 HYDROMORPHONE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
01/26/2018 DILAUDID-HP
NDA #019034
SUPPL-30 HYDROMORPHONE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800
ORIG-1 TENOFOVIR DISOPROXIL FUMARATE CIPLA Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #078800
ORIG-2 TENOFOVIR DISOPROXIL FUMARATE CIPLA Approval
01/26/2018 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090513
ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090636
ORIG-1 TENOFOVIR DISOPROXIL FUMARATE HETERO LABS LTD III Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090636
ORIG-2 TENOFOVIR DISOPROXIL FUMARATE HETERO LABS LTD III Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647
ORIG-1 TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647
ORIG-2 TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090647
ORIG-3 TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #090742
ORIG-1 TENOFOVIR DISOPROXIL FUMARATE STRIDES PHARMA Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #091612
SUPPL-1 TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Tentative Approval
01/26/2018 STRENSIQ
BLA #125513
SUPPL-3 ASFOTASE ALFA ALEXION PHARM Approval
01/26/2018 GEMCITABINE HYDROCHLORIDE
NDA #200795
SUPPL-8 GEMCITABINE HYDROCHLORIDE HOSPIRA INC Labeling Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232
ORIG-1 TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Approval
01/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232
ORIG-2 TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Approval
01/26/2018 INJECTAFER
NDA #203565
SUPPL-5 FERRIC CARBOXYMALTOSE AM REGENT Efficacy Approval
01/26/2018 ZYDELIG
NDA #205858
SUPPL-9 IDELALISIB GILEAD SCIENCES INC Labeling Approval
01/26/2018 COTELLIC
NDA #206192
SUPPL-2 COBIMETINIB FUMARATE GENENTECH INC Efficacy Approval
01/26/2018 ARGATROBAN
ANDA #206698
ORIG-1 ARGATROBAN AMNEAL PHARMS CO Approval
01/26/2018 JADENU
NDA #206910
SUPPL-5 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
01/26/2018 LUTATHERA
NDA #208700
ORIG-1 LUTETIUM DOTATATE LU-177 AAA USA INC Type 1 - New Molecular Entity Approval
01/26/2018 FIRVANQ KIT
NDA #208910
ORIG-1 VANCOMYCIN HYDROCHLORIDE RXMTM THERAPS LLC Type 5 - New Formulation or New Manufacturer Approval
01/26/2018 ATROPINE SULFATE
NDA #209260
ORIG-1 ATROPINE SULFATE FRESENIUS KABI USA Approval
01/26/2018 PIROXICAM
ANDA #210347
ORIG-1 PIROXICAM STRIDES PHARMA Approval
01/26/2018 KAPSPARGO SPRINKLE
NDA #210428
ORIG-1 METOPROLOL SUCCINATE SPIL Type 3 - New Dosage Form Approval
01/26/2018 SILIQ
BLA #761032
SUPPL-4 BRODALUMAB VALEANT LUXEMBOURG Approval
01/26/2018 ERELZI
BLA #761042
SUPPL-1 ETANERCEPT-SZZS SANDOZ Approval
01/29/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #040119
SUPPL-12 ACETAMINOPHEN; CODEINE PHOSPHATE HI TECH PHARMA Labeling Approval
01/29/2018 LAMOTRIGINE
ANDA #078947
SUPPL-26 LAMOTRIGINE TORRENT PHARMS Labeling Approval
01/29/2018 CAPITAL AND CODEINE
ANDA #086024
SUPPL-21 ACETAMINOPHEN; CODEINE PHOSPHATE VALEANT PHARMS LLC Labeling Approval
01/29/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087508
SUPPL-41 ACETAMINOPHEN; CODEINE PHOSPHATE PHARM ASSOC Labeling Approval
01/29/2018 SODIUM POLYSTYRENE SULFONATE
ANDA #089910
SUPPL-9 SODIUM POLYSTYRENE SULFONATE CMP PHARMA INC Labeling Approval
01/29/2018 OFEV
NDA #205832
SUPPL-9 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Labeling Approval
01/29/2018 TRIAMCINOLONE ACETONIDE
ANDA #208848
SUPPL-1 TRIAMCINOLONE ACETONIDE TELIGENT PHARMA INC Manufacturing (CMC) Approval
01/29/2018 TESTOSTERONE
ANDA #209533
ORIG-1 TESTOSTERONE CIPLA Approval
01/29/2018 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #210077
ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE STRIDES PHARMA Approval
01/29/2018 CLONIDINE HYDROCHLORIDE
ANDA #210338
ORIG-1 CLONIDINE HYDROCHLORIDE JUBILANT GENERICS Approval
01/30/2018 BIO-TROPIN
NDA #019774
SUPPL-29 SOMATROPIN FERRING Labeling Approval
01/30/2018 BIO-TROPIN
NDA #019774
SUPPL-40 SOMATROPIN FERRING Efficacy Approval
01/30/2018 BIO-TROPIN
NDA #019774
SUPPL-45 SOMATROPIN FERRING Efficacy Approval
01/30/2018 BIO-TROPIN
NDA #019774
SUPPL-47 SOMATROPIN FERRING Labeling Approval
01/30/2018 ZOMACTON
NDA #019774
SUPPL-29 SOMATROPIN FERRING Labeling Approval
01/30/2018 ZOMACTON
NDA #019774
SUPPL-40 SOMATROPIN FERRING Efficacy Approval
01/30/2018 ZOMACTON
NDA #019774
SUPPL-45 SOMATROPIN FERRING Efficacy Approval
01/30/2018 ZOMACTON
NDA #019774
SUPPL-47 SOMATROPIN FERRING Labeling Approval
01/30/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085861
SUPPL-75 ACETAMINOPHEN; CODEINE PHOSPHATE ACTAVIS MID ATLANTIC Labeling Approval
01/30/2018 AMPICILLIN SODIUM
ANDA #090884
SUPPL-1 AMPICILLIN SODIUM ACS DOBFAR SPA Labeling Approval
01/30/2018 AMPICILLIN SODIUM
ANDA #090884
SUPPL-2 AMPICILLIN SODIUM ACS DOBFAR SPA Labeling Approval
01/30/2018 ARGATROBAN
NDA #201811
SUPPL-6 ARGATROBAN FRESENIUS KABI USA Labeling Approval
01/30/2018 PERAMPANEL
ANDA #209877
ORIG-1 PERAMPANEL ACCORD HLTHCARE INC Tentative Approval
01/30/2018 CLOBETASOL PROPIONATE
ANDA #210208
ORIG-1 CLOBETASOL PROPIONATE LUPIN LTD Approval
01/31/2018 METHADONE HYDROCHLORIDE
ANDA #087393
SUPPL-44 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
01/31/2018 METHADONE HYDROCHLORIDE
ANDA #087997
SUPPL-36 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
01/31/2018 METHADONE HYDROCHLORIDE
ANDA #090707
SUPPL-14 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
01/31/2018 METHADONE HYDROCHLORIDE
ANDA #090707
SUPPL-15 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090819
SUPPL-11 BUPRENORPHINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149
SUPPL-10 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422
SUPPL-20 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422
SUPPL-23 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066
SUPPL-6 BUPRENORPHINE HYDROCHLORIDE MYLAN Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066
SUPPL-7 BUPRENORPHINE HYDROCHLORIDE MYLAN Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633
SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUN PHARM Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201760
SUPPL-7 BUPRENORPHINE HYDROCHLORIDE SUN PHARM Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136
SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
01/31/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431
SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ETHYPHARM USA CORP Labeling Approval

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