Drugs@FDA: FDA Approved Drug Products

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All Approvals
February 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 February 18, 2018.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/01/2018 DOLOPHINE HYDROCHLORIDE
NDA #006134
SUPPL-45 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
NDA #006383
SUPPL-18 METHADONE HYDROCHLORIDE MALLINCKRODT INC Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
NDA #017058
SUPPL-25 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/01/2018 METHADOSE
NDA #017116
SUPPL-32 METHADONE HYDROCHLORIDE SPECGX LLC Labeling Approval
02/01/2018 SEPTRA
NDA #017376
SUPPL-61 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
02/01/2018 SEPTRA DS
NDA #017376
SUPPL-61 SULFAMETHOXAZOLE; TRIMETHOPRIM MONARCH PHARMS Labeling Approval
02/01/2018 SUBUTEX
NDA #020732
SUPPL-18 BUPRENORPHINE HYDROCHLORIDE INDIVIOR INC Labeling Approval
02/01/2018 SUBOXONE
NDA #020733
SUPPL-22 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC Labeling Approval
02/01/2018 MICARDIS
NDA #020850
SUPPL-40 TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
02/01/2018 ZYVOX
NDA #021130
SUPPL-37 LINEZOLID PHARMACIA AND UPJOHN Labeling Approval
02/01/2018 ZYVOX
NDA #021131
SUPPL-30 LINEZOLID PHARMACIA AND UPJOHN Labeling Approval
02/01/2018 ZYVOX
NDA #021132
SUPPL-35 LINEZOLID PHARMACIA AND UPJOHN Labeling Approval
02/01/2018 MICARDIS HCT
NDA #021162
SUPPL-40 HYDROCHLOROTHIAZIDE; TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
02/01/2018 SPIRIVA
NDA #021395
SUPPL-48 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Labeling Approval
02/01/2018 REVATIO
NDA #021845
SUPPL-18 SILDENAFIL CITRATE PFIZER Labeling Approval
02/01/2018 TWYNSTA
NDA #022401
SUPPL-19 AMLODIPINE BESYLATE; TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
02/01/2018 SUBOXONE
NDA #022410
SUPPL-31 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633
SUPPL-15 BUPRENORPHINE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
ANDA #087393
SUPPL-45 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
ANDA #087997
SUPPL-37 METHADONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090279
SUPPL-8 BUPRENORPHINE HYDROCHLORIDE SANDOZ INC Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360
SUPPL-15 BUPRENORPHINE HYDROCHLORIDE BARR Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622
SUPPL-25 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
ANDA #090707
SUPPL-16 METHADONE HYDROCHLORIDE VISTAPHARM Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090819
SUPPL-12 BUPRENORPHINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149
SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149
SUPPL-12 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422
SUPPL-24 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201066
SUPPL-8 BUPRENORPHINE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633
SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201760
SUPPL-8 BUPRENORPHINE HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
02/01/2018 EDURANT
NDA #202022
SUPPL-11 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Efficacy Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136
SUPPL-16 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136
SUPPL-17 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326
SUPPL-10 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE WEST-WARD PHARMS INT Labeling Approval
02/01/2018 ZUBSOLV
NDA #204242
SUPPL-14 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE OREXO US INC Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #204431
SUPPL-13 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ETHYPHARM USA CORP Labeling Approval
02/01/2018 PROBUPHINE
NDA #204442
SUPPL-6 BUPRENORPHINE HYDROCHLORIDE BRAEBURN PHARMS INC Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022
SUPPL-2 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE KREMERS URBAN PHARMS Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022
SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE KREMERS URBAN PHARMS Labeling Approval
02/01/2018 BUNAVAIL
NDA #205637
SUPPL-16 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI Labeling Approval
02/01/2018 AVYCAZ
NDA #206494
SUPPL-4 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN SALES LLC Efficacy Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #207276
SUPPL-3 BUPRENORPHINE HYDROCHLORIDE RHODES PHARMS Labeling Approval
02/01/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207515
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE AMNEAL PHARMS Approval
02/01/2018 OCALIVA
NDA #207999
SUPPL-3 OBETICHOLIC ACID INTERCEPT PHARMS INC Labeling Approval
02/01/2018 NIACIN
ANDA #209236
ORIG-1 NIACIN AUROBINDO PHARMA LTD Approval
02/02/2018 FERAHEME
NDA #022180
SUPPL-9 FERUMOXYTOL AMAG PHARMS INC Efficacy Approval
02/02/2018 XOFIGO
NDA #203971
SUPPL-12 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Labeling Approval
02/02/2018 ZYDELIG
NDA #205858
SUPPL-11 IDELALISIB GILEAD SCIENCES INC Labeling Approval
02/02/2018 PRASUGREL
ANDA #205987
ORIG-1 PRASUGREL HYDROCHLORIDE ACCORD HLTHCARE Approval
02/02/2018 OXYMORPHONE HYDROCHLORIDE
ANDA #210175
ORIG-1 OXYMORPHONE HYDROCHLORIDE ASCENT PHARMS INC Approval
02/05/2018 PEDIAPRED
NDA #019157
SUPPL-21 PREDNISOLONE SODIUM PHOSPHATE SETON PHARM Labeling Approval
02/05/2018 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL
NDA #208255
ORIG-1 EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL MYLAN PHARMS INC Type 3 - New Dosage Form Approval
02/05/2018 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL
NDA #208255
ORIG-2 EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL MYLAN PHARMS INC Type 3 - New Dosage Form Approval
02/05/2018 TYMLOS
NDA #208743
SUPPL-1 ABALOPARATIDE RADIUS HEALTH INC Labeling Approval
02/06/2018 SODIUM IODIDE I 131
NDA #016515
SUPPL-16 SODIUM IODIDE I-131 MALLINKRODT NUCLEAR Labeling Approval
02/06/2018 SODIUM IODIDE I 131
NDA #016517
SUPPL-16 SODIUM IODIDE I-131 MALLINKRODT NUCLEAR Labeling Approval
02/06/2018 CLARINEX-D 12 HOUR
NDA #021313
SUPPL-9 DESLORATADINE; PSEUDOEPHEDRINE SULFATE MERCK SHARP DOHME Labeling Approval
02/06/2018 ULORIC
NDA #021856
SUPPL-12 FEBUXOSTAT TAKEDA PHARMS USA Labeling Approval
02/06/2018 PRISTIQ
NDA #021992
SUPPL-42 DESVENLAFAXINE SUCCINATE WYETH PHARMS INC Efficacy Approval
02/06/2018 METOPROLOL SUCCINATE
ANDA #204106
ORIG-1 METOPROLOL SUCCINATE NOVAST LABS LTD Approval
02/06/2018 ZYDELIG
NDA #205858
SUPPL-10 IDELALISIB GILEAD SCIENCES INC REMS Approval
02/06/2018 IBRANCE
NDA #207103
SUPPL-7 PALBOCICLIB PFIZER INC Efficacy Approval
02/06/2018 LYNPARZA
NDA #208558
SUPPL-2 OLAPARIB ASTRAZENECA PHARMS Labeling Approval
02/06/2018 INGENOL MEBUTATE
ANDA #209086
ORIG-1 INGENOL MEBUTATE ACTAVIS LABS Tentative Approval
02/06/2018 BETAMETHASONE DIPROPIONATE
ANDA #209896
ORIG-1 BETAMETHASONE DIPROPIONATE HI-TECH PHARMACAL Approval
02/07/2018 DORYX
NDA #050582
SUPPL-30 DOXYCYCLINE HYCLATE MAYNE PHARMA INTL Labeling Approval
02/07/2018 DORYX
NDA #050795
SUPPL-26 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
02/07/2018 DORYX MPC
NDA #050795
SUPPL-26 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
02/07/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087006
SUPPL-32 ACETAMINOPHEN; CODEINE PHOSPHATE WOCKHARDT BIO AG Labeling Approval
02/07/2018 ZYTIGA
NDA #202379
SUPPL-24 ABIRATERONE ACETATE JANSSEN BIOTECH Efficacy Approval
02/07/2018 XALKORI
NDA #202570
SUPPL-23 CRIZOTINIB PF PRISM CV Labeling Approval
02/07/2018 XALKORI
NDA #202570
SUPPL-24 CRIZOTINIB PF PRISM CV Labeling Approval
02/07/2018 TRIENTINE HYDROCHLORIDE
ANDA #207567
ORIG-1 TRIENTINE HYDROCHLORIDE WATSON LABS TEVA Approval
02/07/2018 HYDROCORTISONE BUTYRATE
ANDA #210209
ORIG-1 HYDROCORTISONE BUTYRATE LUPIN LTD Manufacturing (CMC) Tentative Approval
02/07/2018 BIKTARVY
NDA #210251
ORIG-1 BICTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE GILEAD SCIENCES INC Type 1 - New Molecular Entity and Type 4 - New Combination Approval
02/07/2018 AMANTADINE HYDROCHLORIDE
ANDA #210403
ORIG-1 AMANTADINE HYDROCHLORIDE JUBILANT GENERICS Approval
02/08/2018 TOTECT
NDA #022025
SUPPL-16 DEXRAZOXANE HYDROCHLORIDE CLINIGEN HLTHCARE Labeling Approval
02/08/2018 YERVOY
BLA #125377
SUPPL-93 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
02/08/2018 RADIOGENIX SYSTEM
NDA #202158
ORIG-1 SODIUM PERTECHNETATE NORTHSTAR MEDICAL RADIOISOTOPES LLC Type 5 - New Formulation or New Manufacturer Approval
02/08/2018 XARELTO
NDA #202439
SUPPL-24 RIVAROXABAN JANSSEN PHARMS Labeling Approval
02/08/2018 EXONDYS 51
NDA #206488
SUPPL-6 ETEPLIRSEN SAREPTA THERAPS INC Labeling Approval
02/08/2018 CLINDAMYCIN PHOSPHATE
ANDA #209846
ORIG-1 CLINDAMYCIN PHOSPHATE GLASSHOUSE PHARMS Approval
02/09/2018 CELESTONE SOLUSPAN
NDA #014602
SUPPL-61 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE MERCK SHARP DOHME Labeling Approval
02/09/2018 KINEVAC
NDA #017697
SUPPL-31 SINCALIDE BRACCO Labeling Approval
02/09/2018 BACTRIM
NDA #018374
SUPPL-26 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDS INC Labeling Approval
02/09/2018 JANUVIA
NDA #021995
SUPPL-42 SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
02/09/2018 JANUMET
NDA #022044
SUPPL-43 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
02/09/2018 BEPREVE
NDA #022288
SUPPL-8 BEPOTASTINE BESILATE BAUSCH AND LOMB INC Labeling Approval
02/09/2018 SIMPONI
BLA #125289
SUPPL-141 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
02/09/2018 SIMPONI ARIA
BLA #125433
SUPPL-24 GOLIMUMAB JANSSEN BIOTECH Approval
02/09/2018 ELIQUIS
NDA #202155
SUPPL-18 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
02/09/2018 JANUMET XR
NDA #202270
SUPPL-18 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
02/09/2018 REXULTI
NDA #205422
SUPPL-3 BREXPIPRAZOLE OTSUKA PHARM CO LTD Labeling Approval
02/09/2018 DEXYCU
NDA #208912
ORIG-1 DEXAMETHASONE ICON BIOSCIENCE INC Type 5 - New Formulation or New Manufacturer Approval
02/09/2018 FENOFIBRATE
ANDA #209951
ORIG-1 FENOFIBRATE AMNEAL PHARMS LLC Approval
02/09/2018 MEMANTINE HYDROCHLORIDE
ANDA #209955
ORIG-1 MEMANTINE HYDROCHLORIDE APOTEX INC Approval
02/09/2018 DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
ANDA #210237
ORIG-1 DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE MYLAN LABS Type 4 - New Combination Tentative Approval
02/09/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #210644
ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ABHAI LLC Approval
02/12/2018 LOMOTIL
NDA #012462
SUPPL-48 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE GD SEARLE LLC Labeling Approval
02/12/2018 NUVARING
NDA #021187
SUPPL-31 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON SUB MERCK Labeling Approval
02/12/2018 GLATOPA
ANDA #206921
ORIG-1 GLATIRAMER ACETATE SANDOZ INC Approval
02/12/2018 SYMDEKO
NDA #210491
ORIG-1 TEZACAFTOR; IVACAFTOR VERTEX PHARMS Type 1 - New Molecular Entity Approval
02/13/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077535
SUPPL-15 ONDANSETRON HYDROCHLORIDE GLENMARK GENERICS Labeling Approval
02/13/2018 ONDANSETRON
ANDA #078152
SUPPL-14 ONDANSETRON GLENMARK GENERICS Labeling Approval
02/13/2018 OPDIVO
BLA #125554
SUPPL-56 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
02/13/2018 DOXAZOSIN MESYLATE
ANDA #205210
ORIG-1 DOXAZOSIN MESYLATE HERITAGE PHARMA Approval
02/13/2018 BETAMETHASONE DIPROPIONATE
ANDA #206389
ORIG-1 BETAMETHASONE DIPROPIONATE TELIGENT PHARMA INC Approval
02/13/2018 INTRAROSA
NDA #208470
SUPPL-1 PRASTERONE AMAG PHARMS INC Labeling Approval
02/14/2018 PREVANTICS MAXI SWABSTICK
NDA #021524
SUPPL-12 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Efficacy Approval
02/14/2018 PREVANTICS SWAB
NDA #021524
SUPPL-12 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Efficacy Approval
02/14/2018 PREVANTICS SWABSTICK
NDA #021524
SUPPL-12 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Efficacy Approval
02/14/2018 MAKENA
NDA #021945
SUPPL-12 HYDROXYPROGESTERONE CAPROATE AMAG PHARMA USA Efficacy Approval
02/14/2018 MAKENA PRESERVATIVE FREE
NDA #021945
SUPPL-12 HYDROXYPROGESTERONE CAPROATE AMAG PHARMA USA Efficacy Approval
02/14/2018 ERLEADA
NDA #210951
ORIG-1 APALUTAMIDE JANSSEN BIOTECH Approval
02/15/2018 CIALIS
NDA #021368
SUPPL-30 TADALAFIL LILLY Efficacy Approval
02/15/2018 CHILDREN'S CLARITIN
NDA #021891
SUPPL-26 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
02/15/2018 CYSVIEW KIT
NDA #022555
SUPPL-5 HEXAMINOLEVULINATE HYDROCHLORIDE PHOTOCURE ASA Efficacy Approval
02/15/2018 OPDIVO
BLA #125554
SUPPL-44 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
02/15/2018 OPDIVO
BLA #125554
SUPPL-45 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
02/16/2018 IMFINZI
BLA #761069
SUPPL-2 DURVALUMAB ASTRAZENECA UK LTD 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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