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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 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 26, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/01/2018 DOLOPHINE HYDROCHLORIDE
NDA #006134		 SUPPL-45 METHADONE HYDROCHLORIDE HIKMA 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 HIKMA 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 Labeling Approval
02/01/2018 SUBOXONE
NDA #020733		 SUPPL-22 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Labeling Approval
02/01/2018 MICARDIS
NDA #020850		 SUPPL-40 TELMISARTAN BOEHRINGER INGELHEIM Labeling Approval
02/01/2018 ZYVOX
NDA #021130		 SUPPL-37 LINEZOLID PFIZER Labeling Approval
02/01/2018 ZYVOX
NDA #021131		 SUPPL-30 LINEZOLID PFIZER Labeling Approval
02/01/2018 ZYVOX
NDA #021132		 SUPPL-35 LINEZOLID PFIZER 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 VIATRIS 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 Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-15 BUPRENORPHINE HYDROCHLORIDE HIKMA Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
ANDA #087393		 SUPPL-45 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
02/01/2018 METHADONE HYDROCHLORIDE
ANDA #087997		 SUPPL-37 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #090279		 SUPPL-8 BUPRENORPHINE HYDROCHLORIDE RUBICON 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 LLC 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 Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #201633		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE SUN PHARM Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE
ANDA #201760		 SUPPL-8 BUPRENORPHINE HYDROCHLORIDE SUN PHARM 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 HIKMA 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 TITAN PHARMS Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
02/01/2018 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022		 SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE LANNETT CO INC 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 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 COVIS 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 SYMFI LO
NDA #208255		 ORIG-1 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN Type 3 - New Dosage Form Approval
02/05/2018 TYMLOS
NDA #208743		 SUPPL-1 ABALOPARATIDE RADIUS Labeling Approval
02/06/2018 SODIUM IODIDE I 131
NDA #016515		 SUPPL-16 SODIUM IODIDE I-131 CURIUM Labeling Approval
02/06/2018 SODIUM IODIDE I 131
NDA #016517		 SUPPL-16 SODIUM IODIDE I-131 CURIUM Labeling Approval
02/06/2018 CLARINEX-D 12 HOUR
NDA #021313		 SUPPL-9 DESLORATADINE; PSEUDOEPHEDRINE SULFATE ORGANON LLC 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 PF PRISM CV Efficacy Approval
02/06/2018 METOPROLOL SUCCINATE
ANDA #204106		 ORIG-1 METOPROLOL SUCCINATE NOVAST LABS 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 Efficacy Approval
02/06/2018 LYNPARZA
NDA #208558		 SUPPL-2 OLAPARIB ASTRAZENECA 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 HIKMA Approval
02/07/2018 DORYX
NDA #050582		 SUPPL-30 DOXYCYCLINE HYCLATE MAYNE PHARMA 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 BIKTARVY
NDA #210251		 ORIG-1 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 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 Labeling Approval
02/08/2018 YERVOY
BLA #125377		 SUPPL-93 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
02/08/2018 RADIOGENIX SYSTEM
NDA #202158		 ORIG-1 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR NORTHSTAR MEDICAL 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 CHARTWELL RX Approval
02/09/2018 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-61 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON 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 MSD SUB MERCK 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 MSD SUB MERCK Labeling Approval
02/09/2018 REXULTI
NDA #205422		 SUPPL-3 BREXPIPRAZOLE OTSUKA Labeling Approval
02/09/2018 DEXYCU KIT
NDA #208912		 ORIG-1 DEXAMETHASONE EYEPOINT PHARMS Type 5 - New Formulation or New Manufacturer Approval
02/09/2018 FENOFIBRATE
ANDA #209951		 ORIG-1 FENOFIBRATE AMNEAL Approval
02/09/2018 MEMANTINE HYDROCHLORIDE
ANDA #209955		 ORIG-1 MEMANTINE HYDROCHLORIDE APOTEX Approval
02/09/2018 DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
NDA #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 PFIZER Labeling Approval
02/12/2018 NUVARING
NDA #021187		 SUPPL-31 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Labeling Approval
02/12/2018 GLATOPA
ANDA #206921		 ORIG-1 GLATIRAMER ACETATE SANDOZ Approval
02/12/2018 SYMDEKO (COPACKAGED)
NDA #210491		 ORIG-1 IVACAFTOR; IVACAFTOR, TEZACAFTOR VERTEX PHARMS INC Type 1 - New Molecular Entity and Type 4 - New Combination Approval
02/13/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077535		 SUPPL-15 ONDANSETRON HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
02/13/2018 ONDANSETRON
ANDA #078152		 SUPPL-14 ONDANSETRON GLENMARK PHARMS LTD 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 ENCUBE Approval
02/13/2018 INTRAROSA
NDA #208470		 SUPPL-1 PRASTERONE MILLICENT 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 ERLEADA
NDA #210951		 ORIG-1 APALUTAMIDE JANSSEN BIOTECH Type 1 - New Molecular Entity Approval
02/15/2018 NAROPIN
NDA #020533		 SUPPL-34 ROPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA 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 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 AMPICILLIN SODIUM
ANDA #062719		 SUPPL-8 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #062719		 SUPPL-9 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #062719		 SUPPL-10 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #062772		 SUPPL-13 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #062797		 SUPPL-6 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #062797		 SUPPL-7 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #062797		 SUPPL-8 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #065493		 SUPPL-4 AMPICILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #065493		 SUPPL-7 AMPICILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #090581		 SUPPL-2 AMPICILLIN SODIUM SAGENT PHARMS INC Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #090583		 SUPPL-1 AMPICILLIN SODIUM SAGENT PHARMS INC Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #090583		 SUPPL-2 AMPICILLIN SODIUM SAGENT PHARMS INC Labeling 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
02/15/2018 AMPICILLIN SODIUM
ANDA #201404		 SUPPL-1 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #201404		 SUPPL-2 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #202198		 SUPPL-1 AMPICILLIN SODIUM STERISCIENCE Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #202198		 SUPPL-2 AMPICILLIN SODIUM STERISCIENCE Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #202198		 SUPPL-4 AMPICILLIN SODIUM STERISCIENCE Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #202864		 SUPPL-1 AMPICILLIN SODIUM HOSPIRA Labeling Approval
02/15/2018 AMPICILLIN SODIUM
ANDA #202865		 SUPPL-1 AMPICILLIN SODIUM HOSPIRA Labeling Approval
02/15/2018 SUMATRIPTAN AND NAPROXEN SODIUM
ANDA #207457		 ORIG-1 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE AUROBINDO PHARMA LTD Approval
02/15/2018 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #209990		 ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE AMNEAL Approval
02/16/2018 ISOVUE-200
NDA #020327		 SUPPL-14 IOPAMIDOL BRACCO Labeling Approval
02/16/2018 ISOVUE-250
NDA #020327		 SUPPL-14 IOPAMIDOL BRACCO Labeling Approval
02/16/2018 ISOVUE-300
NDA #020327		 SUPPL-14 IOPAMIDOL BRACCO Labeling Approval
02/16/2018 ISOVUE-370
NDA #020327		 SUPPL-14 IOPAMIDOL BRACCO Labeling Approval
02/16/2018 EXJADE
NDA #021882		 SUPPL-26 DEFERASIROX NOVARTIS Labeling Approval
02/16/2018 VALACYCLOVIR HYDROCHLORIDE
ANDA #076588		 SUPPL-16 VALACYCLOVIR HYDROCHLORIDE SUN PHARM INDS LTD Manufacturing (CMC) Approval
02/16/2018 STELARA
BLA #125261		 SUPPL-141 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
02/16/2018 ENTYVIO
BLA #125476		 SUPPL-22 VEDOLIZUMAB TAKEDA PHARMS USA Approval
02/16/2018 ADENOSINE
ANDA #206778		 ORIG-1 ADENOSINE GLAND PHARMA LTD Approval
02/16/2018 JADENU
NDA #206910		 SUPPL-7 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
02/16/2018 JADENU SPRINKLE
NDA #207968		 SUPPL-2 DEFERASIROX NOVARTIS Labeling Approval
02/16/2018 IBUPROFEN
ANDA #209178		 ORIG-1 IBUPROFEN AUROBINDO PHARMA LTD Approval
02/16/2018 OSMOLEX ER
NDA #209410		 ORIG-1 AMANTADINE HYDROCHLORIDE ADAMAS OPERATIONS Type 3 - New Dosage Form Approval
02/16/2018 ELTROMBOPAG
ANDA #209938		 ORIG-1 ELTROMBOPAG TEVA PHARMS USA INC Tentative Approval
02/16/2018 IMBRUVICA
NDA #210563		 ORIG-1 IBRUTINIB PHARMACYCLICS LLC Type 3 - New Dosage Form Approval
02/16/2018 IMBRUVICA
NDA #210563		 ORIG-2 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
02/16/2018 IMFINZI
BLA #761069		 SUPPL-2 DURVALUMAB ASTRAZENECA UK LTD Approval
02/20/2018 LEVONORGESTREL
ANDA #202246		 SUPPL-4 LEVONORGESTREL ALVOGEN Labeling Approval
02/20/2018 LUZU
NDA #204153		 SUPPL-4 LULICONAZOLE BAUSCH Efficacy Approval
02/20/2018 LUZU
NDA #204153		 SUPPL-5 LULICONAZOLE BAUSCH Efficacy Approval
02/20/2018 PURIXAN
NDA #205919		 SUPPL-3 MERCAPTOPURINE NOVA LABS LTD Labeling Approval
02/20/2018 OSELTAMIVIR PHOSPHATE
ANDA #208347		 ORIG-1 OSELTAMIVIR PHOSPHATE LUPIN Approval
02/21/2018 VOLTAREN ARTHRITIS PAIN
NDA #022122		 SUPPL-11 DICLOFENAC SODIUM HALEON US HOLDINGS Labeling Approval
02/21/2018 AMPICILLIN SODIUM
ANDA #061395		 SUPPL-43 AMPICILLIN SODIUM SANDOZ Labeling Approval
02/21/2018 AMPICILLIN SODIUM
ANDA #063142		 SUPPL-13 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
02/21/2018 AMPICILLIN SODIUM
ANDA #063142		 SUPPL-15 AMPICILLIN SODIUM HQ SPECLT PHARMA Labeling Approval
02/21/2018 AMPICILLIN SODIUM
ANDA #065499		 SUPPL-4 AMPICILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
02/21/2018 AMPICILLIN SODIUM
ANDA #065499		 SUPPL-7 AMPICILLIN SODIUM EUGIA PHARMA SPECLTS Labeling Approval
02/21/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-11 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
02/21/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-12 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
02/21/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089450		 SUPPL-23 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL Labeling Approval
02/21/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #091238		 SUPPL-13 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL MOLECULAR Labeling Approval
02/21/2018 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #091238		 SUPPL-14 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL MOLECULAR Labeling Approval
02/21/2018 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #091532		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE SAMSON MEDCL Labeling Approval
02/21/2018 PIROXICAM
ANDA #208991		 ORIG-1 PIROXICAM BRECKENRIDGE Approval
02/22/2018 SOMATULINE DEPOT
NDA #022074		 SUPPL-18 LANREOTIDE ACETATE IPSEN PHARMA Labeling Approval
02/22/2018 RANITIDINE HYDROCHLORIDE
ANDA #209161		 ORIG-1 RANITIDINE HYDROCHLORIDE STRIDES PHARMA Approval
02/22/2018 LUSDUNA
NDA #209764		 ORIG-1 INSULIN GLARGINE MERCK SHARP DOHME Type 5 - New Formulation or New Manufacturer Tentative Approval
02/23/2018 NORDITROPIN
BLA #021148		 SUPPL-37 SOMATROPIN NOVO NORDISK INC Approval
02/23/2018 NORDITROPIN
BLA #021148		 SUPPL-38 SOMATROPIN NOVO NORDISK INC Approval
02/23/2018 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-37 SOMATROPIN NOVO NORDISK INC Approval
02/23/2018 NORDITROPIN FLEXPRO
BLA #021148		 SUPPL-38 SOMATROPIN NOVO NORDISK INC Approval
02/23/2018 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-37 SOMATROPIN NOVO NORDISK INC Approval
02/23/2018 NORDITROPIN NORDIFLEX
BLA #021148		 SUPPL-38 SOMATROPIN NOVO NORDISK INC Approval
02/23/2018 CUVPOSA
NDA #022571		 SUPPL-8 GLYCOPYRROLATE MERZ PHARMS Labeling Approval
02/23/2018 ATOMOXETINE HYDROCHLORIDE
ANDA #090609		 ORIG-1 ATOMOXETINE HYDROCHLORIDE DR REDDYS Approval
02/23/2018 EFAVIRENZ
NDA #205389		 ORIG-1 EFAVIRENZ MICRO LABS LTD INDIA Type 5 - New Formulation or New Manufacturer Tentative Approval
02/23/2018 ALOSETRON HYDROCHLORIDE
ANDA #206113		 ORIG-1 ALOSETRON HYDROCHLORIDE PAR PHARM INC Approval
02/23/2018 APADAZ
NDA #208653		 ORIG-1 ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE ZEVRA THERAP Type 4 - New Combination Approval
02/23/2018 OSELTAMIVIR PHOSPHATE
ANDA #209438		 ORIG-1 OSELTAMIVIR PHOSPHATE HETERO LABS LTD III Approval
02/26/2018 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113		 SUPPL-3 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
02/26/2018 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113		 SUPPL-4 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
02/26/2018 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113		 SUPPL-3 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
02/26/2018 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113		 SUPPL-4 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #076183		 SUPPL-7 ONDANSETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #076183		 SUPPL-9 ONDANSETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #076183		 SUPPL-12 ONDANSETRON HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077303		 SUPPL-2 ONDANSETRON HYDROCHLORIDE CHARTWELL MOLECULES Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-10 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-11 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
02/26/2018 ONDANSETRON HYDROCHLORIDE
ANDA #077306		 SUPPL-12 ONDANSETRON HYDROCHLORIDE APOTEX Labeling Approval
02/26/2018 ONDANSETRON
ANDA #077406		 SUPPL-6 ONDANSETRON CHARTWELL MOLECULES Labeling Approval
02/26/2018 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #077858		 SUPPL-6 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE RISING Labeling Approval
02/26/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #200886		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE DR REDDYS LABS SA Approval
02/26/2018 DESFLURANE
ANDA #208234		 ORIG-1 DESFLURANE SHANGHAI HENGRUI Approval
02/26/2018 VERZENIO
NDA #208855		 ORIG-1 ABEMACICLIB ELI LILLY AND CO Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
02/26/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #209550		 ORIG-1 TENOFOVIR DISOPROXIL FUMARATE CASI PHARMS INC Approval
02/27/2018 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #206798		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE ZYDUS PHARMS Approval
02/27/2018 LO-ZUMANDIMINE
ANDA #209632		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL AUROBINDO PHARMA LTD Approval
02/27/2018 OSELTAMIVIR PHOSPHATE
ANDA #210186		 ORIG-1 OSELTAMIVIR PHOSPHATE AMNEAL PHARMS NY Approval
02/28/2018 CYTOTEC
NDA #019268		 SUPPL-51 MISOPROSTOL PFIZER Labeling Approval
02/28/2018 ZOCOR
NDA #019766		 SUPPL-98 SIMVASTATIN ORGANON Labeling Approval
02/28/2018 ALTOPREV
NDA #021316		 SUPPL-35 LOVASTATIN COVIS Labeling Approval
02/28/2018 CLARINEX D 24 HOUR
NDA #021605		 SUPPL-15 DESLORATADINE; PSEUDOEPHEDRINE SULFATE ORGANON Labeling Approval
02/28/2018 VYTORIN
NDA #021687		 SUPPL-60 EZETIMIBE; SIMVASTATIN ORGANON Labeling Approval
02/28/2018 CIMDUO
NDA #022141		 ORIG-1 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN LABS LTD Type 4 - New Combination Approval
02/28/2018 ACTIVASE
BLA #103172		 SUPPL-5259 ALTEPLASE GENENTECH Approval
02/28/2018 ACTIVASE
BLA #103172		 SUPPL-5260 ALTEPLASE GENENTECH Approval
02/28/2018 CATHFLO ACTIVASE
BLA #103172		 SUPPL-5259 ALTEPLASE GENENTECH Approval
02/28/2018 CATHFLO ACTIVASE
BLA #103172		 SUPPL-5260 ALTEPLASE GENENTECH Approval
02/28/2018 TNKASE
BLA #103909		 SUPPL-5187 TENECTEPLASE GENENTECH Approval
02/28/2018 SOLIRIS
BLA #125166		 SUPPL-426 ECULIZUMAB ALEXION PHARM Approval
02/28/2018 MOVANTIK
NDA #204760		 SUPPL-7 NALOXEGOL OXALATE VALINOR Labeling Approval
02/28/2018 ESOMEPRAZOLE MAGNESIUM
ANDA #207079		 ORIG-1 ESOMEPRAZOLE MAGNESIUM ACTAVIS LABS FL INC Tentative Approval
02/28/2018 ZTLIDO
NDA #207962		 ORIG-1 LIDOCAINE SCILEX PHARMS Type 5 - New Formulation or New Manufacturer Approval
02/28/2018 OMEPRAZOLE
NDA #209400		 SUPPL-1 OMEPRAZOLE DEXCEL Labeling Approval
02/28/2018 ESTRADIOL AND NORETHINDRONE ACETATE
ANDA #210233		 ORIG-1 ESTRADIOL; NORETHINDRONE ACETATE NAARI PTE LTD Approval
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