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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2017

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 May 15, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/02/2017 GEMFIBROZIL
ANDA #077836		 SUPPL-10 GEMFIBROZIL INVAGEN PHARMS Labeling Approval
10/02/2017 GEMFIBROZIL
ANDA #077836		 SUPPL-12 GEMFIBROZIL INVAGEN PHARMS Labeling Approval
10/02/2017 AMLODIPINE BESYLATE
ANDA #078925		 SUPPL-10 AMLODIPINE BESYLATE ALKEM Labeling Approval
10/02/2017 BOTOX
BLA #103000		 SUPPL-5303 OnabotulinumtoxinA ALLERGAN Approval
10/02/2017 BOTOX COSMETIC
BLA #103000		 SUPPL-5303 OnabotulinumtoxinA ALLERGAN Approval
10/02/2017 INTRON A
BLA #103132		 SUPPL-5196 INTERFERON ALFA-2B SCHERING Approval
10/02/2017 PEGINTRON
BLA #103949		 SUPPL-5305 PEGINTERFERON ALFA-2B SCHERING Approval
10/02/2017 PEGINTRON
BLA #103949		 SUPPL-5307 PEGINTERFERON ALFA-2B SCHERING Approval
10/02/2017 SYLATRON
BLA #103949		 SUPPL-5305 PEGINTERFERON ALFA-2B SCHERING Approval
10/02/2017 SYLATRON
BLA #103949		 SUPPL-5307 PEGINTERFERON ALFA-2B SCHERING Approval
10/02/2017 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #206053		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Approval
10/02/2017 ALUNBRIG
NDA #208772		 SUPPL-2 BRIGATINIB TAKEDA PHARMS USA Manufacturing (CMC) Approval
10/02/2017 ASCOR
NDA #209112		 ORIG-1 ASCORBIC ACID MCGUFF Type 7 - Drug Already Marketed without Approved NDA Approval
10/03/2017 DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
ANDA #091345		 ORIG-1 DESMOPRESSIN ACETATE ZYDUS PHARMS Approval
10/03/2017 GLATIRAMER ACETATE
ANDA #091646		 ORIG-1 GLATIRAMER ACETATE MYLAN Approval
10/03/2017 PEGINTRON
BLA #103949		 SUPPL-5306 PEGINTERFERON ALFA-2B SCHERING Approval
10/03/2017 SYLATRON
BLA #103949		 SUPPL-5306 PEGINTERFERON ALFA-2B SCHERING Approval
10/03/2017 FESOTERODINE FUMARATE
ANDA #204946		 ORIG-1 FESOTERODINE FUMARATE ZYDUS PHARMS Approval
10/03/2017 GLATIRAMER ACETATE
ANDA #206936		 ORIG-1 GLATIRAMER ACETATE MYLAN Approval
10/03/2017 TELMISARTAN
ANDA #207016		 ORIG-1 TELMISARTAN MICRO LABS Approval
10/04/2017 MIRALAX
NDA #022015		 SUPPL-27 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
10/04/2017 PROMACTA
NDA #022291		 SUPPL-19 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
10/04/2017 CEFTRIAXONE SODIUM
ANDA #090701		 ORIG-1 CEFTRIAXONE SODIUM HIKMA Approval
10/04/2017 DUTASTERIDE
ANDA #204373		 ORIG-1 DUTASTERIDE ZYDUS LIFESCIENCES Approval
10/04/2017 YOSPRALA
NDA #205103		 SUPPL-1 ASPIRIN; OMEPRAZOLE GENUS LIFESCIENCES Labeling Approval
10/04/2017 MOXIFLOXACIN HYDROCHLORIDE
ANDA #206242		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE EUGIA PHARMA Approval
10/04/2017 FLOLIPID
NDA #206679		 SUPPL-2 SIMVASTATIN SALERNO PHARMS Labeling Approval
10/05/2017 LOMOTIL
NDA #012462		 SUPPL-45 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE PFIZER Labeling Approval
10/05/2017 DEPAKENE
NDA #018081		 SUPPL-67 VALPROIC ACID ABBVIE Labeling Approval
10/05/2017 DEPAKENE
NDA #018082		 SUPPL-50 VALPROIC ACID ABBVIE Labeling Approval
10/05/2017 DEPAKOTE
NDA #018723		 SUPPL-59 DIVALPROEX SODIUM ABBVIE Labeling Approval
10/05/2017 DEPAKOTE
NDA #019680		 SUPPL-46 DIVALPROEX SODIUM ABBVIE Labeling Approval
10/05/2017 ZOFRAN
NDA #020103		 SUPPL-36 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/05/2017 DEPACON
NDA #020593		 SUPPL-37 VALPROATE SODIUM ABBVIE Labeling Approval
10/05/2017 ZOFRAN
NDA #020605		 SUPPL-20 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
10/05/2017 ZOFRAN ODT
NDA #020781		 SUPPL-20 ONDANSETRON SANDOZ Labeling Approval
10/05/2017 DEPAKOTE ER
NDA #021168		 SUPPL-37 DIVALPROEX SODIUM ABBVIE Labeling Approval
10/05/2017 DEXRAZOXANE HYDROCHLORIDE
ANDA #076068		 SUPPL-15 DEXRAZOXANE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
10/05/2017 GABAPENTIN
ANDA #077662		 SUPPL-21 GABAPENTIN GLENMARK PHARMS LTD Labeling Approval
10/05/2017 CAMPATH
BLA #103948		 SUPPL-5157 ALEMTUZUMAB GENZYME Approval
10/05/2017 CAMPATH
BLA #103948		 SUPPL-5158 ALEMTUZUMAB GENZYME Approval
10/05/2017 LEMTRADA
BLA #103948		 SUPPL-5157 ALEMTUZUMAB GENZYME Approval
10/05/2017 LEMTRADA
BLA #103948		 SUPPL-5158 ALEMTUZUMAB GENZYME Approval
10/05/2017 COMETRIQ
NDA #203756		 SUPPL-4 CABOZANTINIB S-MALATE EXELIXIS Labeling Approval
10/05/2017 VENLAFAXINE HYDROCHLORIDE
ANDA #204889		 ORIG-1 VENLAFAXINE HYDROCHLORIDE MACLEODS PHARMS LTD Approval
10/05/2017 NADOLOL
ANDA #209309		 ORIG-1 NADOLOL CHARTWELL RX Approval
10/06/2017 TEMODAR
NDA #021029		 SUPPL-32 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
10/06/2017 DUODOTE
NDA #021983		 SUPPL-23 ATROPINE; PRALIDOXIME CHLORIDE MMT Efficacy Approval
10/06/2017 TEMODAR
NDA #022277		 SUPPL-12 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
10/06/2017 ENBREL
BLA #103795		 SUPPL-5561 ETANERCEPT IMMUNEX Approval
10/06/2017 PIOGLITAZONE HYDROCHLORIDE
ANDA #206738		 ORIG-1 PIOGLITAZONE HYDROCHLORIDE PURACAP PHARM LLC Approval
10/06/2017 NEVIRAPINE
ANDA #206879		 ORIG-1 NEVIRAPINE MACLEODS PHARMS LTD Approval
10/06/2017 AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
ANDA #208436		 ORIG-1 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE TEVA PHARMS USA Tentative Approval
10/06/2017 ZILRETTA
NDA #208845		 ORIG-1 TRIAMCINOLONE ACETONIDE PACIRA PHARMS INC Type 5 - New Formulation or New Manufacturer Approval
10/06/2017 TRIAMCINOLONE ACETONIDE
ANDA #208925		 ORIG-1 TRIAMCINOLONE ACETONIDE COSETTE Approval
10/06/2017 NYSTATIN
ANDA #209114		 ORIG-1 NYSTATIN COSETTE Approval
10/06/2017 DOXYCYCLINE HYCLATE
ANDA #209372		 ORIG-1 DOXYCYCLINE HYCLATE AMNEAL PHARMS CO Approval
10/06/2017 AMITRIPTYLINE HYDROCHLORIDE
ANDA #210086		 ORIG-1 AMITRIPTYLINE HYDROCHLORIDE ZYDUS PHARMS Approval
10/07/2017 SPORANOX
NDA #020083		 SUPPL-61 ITRACONAZOLE JANSSEN PHARMS Labeling Approval
10/07/2017 SPORANOX
NDA #020657		 SUPPL-36 ITRACONAZOLE JANSSEN PHARMS Labeling Approval
10/10/2017 NORINYL 1+35 21-DAY
NDA #017565		 SUPPL-85 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Labeling Approval
10/10/2017 NORINYL 1+35 28-DAY
NDA #017565		 SUPPL-85 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Labeling Approval
10/10/2017 BREVICON 21-DAY
NDA #017566		 SUPPL-92 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Labeling Approval
10/10/2017 BREVICON 28-DAY
NDA #017743		 SUPPL-89 ETHINYL ESTRADIOL; NORETHINDRONE ALLERGAN Labeling Approval
10/10/2017 ESTROSTEP 21
NDA #020130		 SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
10/10/2017 ESTROSTEP FE
NDA #020130		 SUPPL-18 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
10/10/2017 SUSTIVA
NDA #020972		 SUPPL-56 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
10/10/2017 SUSTIVA
NDA #021360		 SUPPL-44 EFAVIRENZ BRISTOL MYERS SQUIBB Labeling Approval
10/10/2017 LO LOESTRIN FE
NDA #022501		 SUPPL-9 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
10/10/2017 JAKAFI
NDA #202192		 SUPPL-14 RUXOLITINIB PHOSPHATE INCYTE CORP Efficacy Approval
10/10/2017 STENDRA
NDA #202276		 SUPPL-17 AVANAFIL METUCHEN PHARMS Labeling Approval
10/10/2017 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
ANDA #202934		 ORIG-1 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE ACTAVIS ELIZABETH Approval
10/10/2017 CLINDAMYCIN PHOSPHATE
ANDA #204748		 ORIG-1 CLINDAMYCIN PHOSPHATE RISING Approval
10/10/2017 CLINDAMYCIN PHOSPHATE
ANDA #204749		 ORIG-1 CLINDAMYCIN PHOSPHATE RISING Approval
10/10/2017 TRAZODONE HYDROCHLORIDE
ANDA #205253		 ORIG-1 TRAZODONE HYDROCHLORIDE ZYDUS PHARMS Approval
10/10/2017 DONEPEZIL HYDROCHLORIDE AND MEMANTINE HYDROCHLORIDE
ANDA #208672		 ORIG-1 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE MACLEODS PHARMS LTD Tentative Approval
10/10/2017 ENTECAVIR
ANDA #208782		 ORIG-1 ENTECAVIR PRINSTON INC Approval
10/11/2017 ALIMTA
NDA #021462		 SUPPL-50 PEMETREXED DISODIUM LILLY Labeling Approval
10/11/2017 DESVENLAFAXINE SUCCINATE
ANDA #204020		 ORIG-1 DESVENLAFAXINE SUCCINATE ZYDUS PHARMS Approval
10/11/2017 LYRICA CR
NDA #209501		 ORIG-1 PREGABALIN UPJOHN Type 5 - New Formulation or New Manufacturer Approval
10/11/2017 ATOVAQUONE
ANDA #209750		 ORIG-1 ATOVAQUONE APOTEX Approval
10/12/2017 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-31 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Labeling Approval
10/12/2017 MOMETASONE FUROATE
ANDA #077401		 SUPPL-5 MOMETASONE FUROATE COSETTE Manufacturing (CMC) Approval
10/12/2017 APREPITANT
ANDA #207777		 ORIG-1 APREPITANT GLENMARK PHARMS SA Approval
10/12/2017 ALLOPURINOL
ANDA #210117		 ORIG-1 ALLOPURINOL ZYDUS PHARMS Approval
10/12/2017 BAVENCIO
BLA #761049		 SUPPL-2 AVELUMAB EMD SERONO INC Approval
10/13/2017 KALETRA
NDA #021251		 SUPPL-55 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/13/2017 BUTRANS
NDA #021306		 SUPPL-27 BUPRENORPHINE PURDUE PHARMA LP Efficacy Approval
10/13/2017 KALETRA
NDA #021906		 SUPPL-50 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
10/13/2017 CEFTIN
NDA #050605		 SUPPL-50 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
10/13/2017 CEFTIN
NDA #050672		 SUPPL-36 CEFUROXIME AXETIL GLAXOSMITHKLINE Labeling Approval
10/13/2017 PEGASYS
BLA #103964		 SUPPL-5270 PEGINTERFERON ALFA-2A zr pharma& Approval
10/13/2017 STELARA
BLA #125261		 SUPPL-138 USTEKINUMAB CENTOCOR ORTHO BIOTECH INC Approval
10/13/2017 MITOMYCIN
ANDA #202670		 ORIG-1 MITOMYCIN RK PHARMA Approval
10/13/2017 MITOMYCIN
ANDA #203386		 ORIG-1 MITOMYCIN RK PHARMA Approval
10/13/2017 PROCAINAMIDE HYDROCHLORIDE
ANDA #206332		 ORIG-1 PROCAINAMIDE HYDROCHLORIDE NEXUS Approval
10/13/2017 TIAGABINE HYDROCHLORIDE
ANDA #206857		 ORIG-1 TIAGABINE HYDROCHLORIDE WILSHIRE PHARMS INC Approval
10/13/2017 DUTASTERIDE
ANDA #207935		 ORIG-1 DUTASTERIDE HERITAGE PHARMS INC Approval
10/13/2017 TOBRAMYCIN
ANDA #209554		 ORIG-1 TOBRAMYCIN MYLAN Approval
10/15/2017 MEPRON
NDA #020500		 SUPPL-16 ATOVAQUONE GLAXOSMITHKLINE LLC Labeling Approval
10/16/2017 VENTAVIS
NDA #021779		 SUPPL-18 ILOPROST ACTELION Labeling Approval
10/16/2017 NEOPROFEN
NDA #021903		 SUPPL-10 IBUPROFEN LYSINE RECORDATI RARE Labeling Approval
10/16/2017 CHANTIX
NDA #021928		 SUPPL-42 VARENICLINE TARTRATE PF PRISM CV Labeling Approval
10/16/2017 XYZAL
NDA #022064		 SUPPL-34 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI Labeling Approval
10/16/2017 XYZAL
NDA #022157		 SUPPL-17 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI Labeling Approval
10/16/2017 NITROGLYCERIN
ANDA #203693		 ORIG-1 NITROGLYCERIN ACTAVIS LABS FL INC Approval
10/16/2017 PRASUGREL
ANDA #205790		 ORIG-1 PRASUGREL HYDROCHLORIDE CHARTWELL RX Approval
10/16/2017 PRASUGREL
ANDA #205888		 ORIG-1 PRASUGREL HYDROCHLORIDE AUROBINDO PHARMA Approval
10/16/2017 PRASUGREL
ANDA #205897		 ORIG-1 PRASUGREL HYDROCHLORIDE PANACEA Approval
10/16/2017 TRIFERIC
NDA #206317		 SUPPL-9 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
10/16/2017 PARICALCITOL
ANDA #207692		 ORIG-1 PARICALCITOL EPIC PHARMA LLC Approval
10/16/2017 EUCRISA
NDA #207695		 SUPPL-2 CRISABOROLE ANACOR PHARMS INC Labeling Approval
10/16/2017 TRIFERIC
NDA #208551		 SUPPL-3 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Labeling Approval
10/16/2017 CROMOLYN SODIUM
ANDA #209264		 ORIG-1 CROMOLYN SODIUM AILEX PHARMS LLC Approval
10/16/2017 ESOMEPRAZOLE MAGNESIUM
ANDA #209339		 ORIG-1 ESOMEPRAZOLE MAGNESIUM AUROBINDO PHARMA Approval
10/16/2017 CROMOLYN SODIUM
ANDA #209453		 ORIG-1 CROMOLYN SODIUM AILEX PHARMS LLC Approval
10/16/2017 DAPSONE
ANDA #209506		 ORIG-1 DAPSONE TARO Approval
10/17/2017 STERILE WATER
NDA #017428		 SUPPL-71 STERILE WATER FOR IRRIGATION BAXTER HLTHCARE Labeling Approval
10/17/2017 HIBICLENS
NDA #017768		 SUPPL-44 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Labeling Approval
10/17/2017 STERILE WATER IN PLASTIC CONTAINER
NDA #017866		 SUPPL-52 STERILE WATER FOR IRRIGATION BAXTER HLTHCARE Labeling Approval
10/17/2017 ENTOCORT EC
NDA #021324		 SUPPL-16 BUDESONIDE PADAGIS US Labeling Approval
10/17/2017 DEXILANT
NDA #022287		 SUPPL-27 DEXLANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
10/17/2017 ANORO ELLIPTA
NDA #203975		 SUPPL-7 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Labeling Approval
10/17/2017 ALBUTEROL SULFATE
ANDA #206224		 ORIG-1 ALBUTEROL SULFATE LUOXIN AUROVITAS Approval
10/17/2017 FLUCYTOSINE
ANDA #206550		 ORIG-1 FLUCYTOSINE HIKMA Approval
10/17/2017 NUPLAZID
NDA #207318		 SUPPL-1 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
10/17/2017 FLUPHENAZINE DECANOATE
ANDA #207739		 ORIG-1 FLUPHENAZINE DECANOATE EUGIA PHARMA Approval
10/18/2017 LO/OVRAL FE
NDA #018206		 SUPPL-20 ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE CADENCE HEALTH Labeling Approval
10/18/2017 NEURONTIN
NDA #020235		 SUPPL-64 GABAPENTIN VIATRIS Labeling Approval
10/18/2017 ADVIL LIQUI-GELS
NDA #020402		 SUPPL-44 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
10/18/2017 ADVIL MIGRAINE LIQUI-GELS
NDA #020402		 SUPPL-44 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
10/18/2017 PREVACID
NDA #020406		 SUPPL-83 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
10/18/2017 NEURONTIN
NDA #020882		 SUPPL-47 GABAPENTIN VIATRIS Labeling Approval
10/18/2017 NEURONTIN
NDA #021129		 SUPPL-46 GABAPENTIN VIATRIS Labeling Approval
10/18/2017 PREVACID
NDA #021428		 SUPPL-31 LANSOPRAZOLE TAKEDA PHARMS USA Labeling Approval
10/18/2017 AZITHROMYCIN
ANDA #065150		 SUPPL-15 AZITHROMYCIN TEVA Labeling Approval
10/18/2017 AZITHROMYCIN
ANDA #065150		 SUPPL-16 AZITHROMYCIN TEVA Labeling Approval
10/18/2017 AZITHROMYCIN
ANDA #065150		 SUPPL-17 AZITHROMYCIN TEVA Labeling Approval
10/18/2017 BUMETANIDE
ANDA #209724		 ORIG-1 BUMETANIDE AMNEAL PHARMS CO Approval
10/18/2017 DEXTROAMPHETAMINE SULFATE
ANDA #210059		 ORIG-1 DEXTROAMPHETAMINE SULFATE NUVO PHARM Approval
10/19/2017 TYVASO
NDA #022387		 SUPPL-15 TREPROSTINIL UNITED THERAP Efficacy Approval
10/19/2017 NITHIODOTE
NDA #201444		 SUPPL-19 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Labeling Approval
10/19/2017 SODIUM NITRITE
NDA #203922		 SUPPL-1 SODIUM NITRITE HOPE PHARMS Labeling Approval
10/19/2017 SODIUM THIOSULFATE
NDA #203923		 SUPPL-1 SODIUM THIOSULFATE HOPE PHARMS Labeling Approval
10/19/2017 LINAGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA #208421		 ORIG-1 LINAGLIPTIN;METFORMIN HYDROCHLORIDE ACCORD HLTHCARE INC Tentative Approval
10/20/2017 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BLA #017881		 SUPPL-26 TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT DRAXIMAGE Approval
10/20/2017 TRACLEER
NDA #021290		 SUPPL-35 BOSENTAN ACTELION REMS Approval
10/20/2017 REYATAZ
NDA #021567		 SUPPL-41 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
10/20/2017 BYDUREON
NDA #022200		 SUPPL-25 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
10/20/2017 BYDUREON PEN
NDA #022200		 SUPPL-25 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
10/20/2017 DESLORATADINE
ANDA #078361		 SUPPL-5 DESLORATADINE PERRIGO Labeling Approval
10/20/2017 YERVOY
BLA #125377		 SUPPL-86 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
10/20/2017 SIMPONI ARIA
BLA #125433		 SUPPL-20 GOLIMUMAB JANSSEN BIOTECH Approval
10/20/2017 SIMPONI ARIA
BLA #125433		 SUPPL-21 GOLIMUMAB JANSSEN BIOTECH Approval
10/20/2017 DICLOFENAC SODIUM
ANDA #202027		 SUPPL-3 DICLOFENAC SODIUM APOTEX Manufacturing (CMC) Approval
10/20/2017 DICLOFENAC SODIUM
ANDA #202027		 SUPPL-4 DICLOFENAC SODIUM APOTEX Labeling Approval
10/20/2017 FARXIGA
NDA #202293		 SUPPL-12 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
10/20/2017 HYDROMORPHONE HYDROCHLORIDE
ANDA #204278		 SUPPL-2 HYDROMORPHONE HYDROCHLORIDE PADAGIS US Labeling Approval
10/20/2017 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #204755		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM MICRO LABS LTD INDIA Labeling Approval
10/20/2017 CARBIDOPA
ANDA #204763		 ORIG-1 CARBIDOPA NOVEL LABS INC Approval
10/20/2017 PROGESTERONE
ANDA #205229		 ORIG-1 PROGESTERONE XIROMED Approval
10/20/2017 INCRUSE ELLIPTA
NDA #205382		 SUPPL-8 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Labeling Approval
10/20/2017 REYATAZ
NDA #206352		 SUPPL-6 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
10/20/2017 FLUTICASONE PROPIONATE
ANDA #208150		 SUPPL-5 FLUTICASONE PROPIONATE APOTEX Labeling Approval
10/20/2017 ESOMEPRAZOLE MAGNESIUM
ANDA #208333		 ORIG-1 ESOMEPRAZOLE MAGNESIUM ALKEM LABS LTD Approval
10/20/2017 LINAGLIPTIN
ANDA #208457		 ORIG-1 LINAGLIPTIN MSN LABS PVT LTD Tentative Approval
10/20/2017 BYDUREON BCISE
NDA #209210		 ORIG-1 EXENATIDE SYNTHETIC ASTRAZENECA AB Type 3 - New Dosage Form Approval
10/20/2017 TRACLEER
NDA #209279		 SUPPL-1 BOSENTAN ACTELION REMS Approval
10/20/2017 DAPTOMYCIN
NDA #209949		 ORIG-1 DAPTOMYCIN XELLIA PHARMS APS Type 5 - New Formulation or New Manufacturer Approval
10/23/2017 SABRIL
NDA #020427		 SUPPL-17 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
10/23/2017 SABRIL
NDA #022006		 SUPPL-19 VIGABATRIN LUNDBECK PHARMS LLC REMS Approval
10/23/2017 SOMATULINE DEPOT
NDA #022074		 SUPPL-20 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
10/23/2017 PIPERACILLIN AND TAZOBACTAM
ANDA #065386		 SUPPL-3 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM HOSPIRA INC Labeling Approval
10/23/2017 PIPERACILLIN AND TAZOBACTAM
ANDA #065386		 SUPPL-7 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM HOSPIRA INC Labeling Approval
10/23/2017 PIPERACILLIN AND TAZOBACTAM
ANDA #065386		 SUPPL-10 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM HOSPIRA INC Labeling Approval
10/23/2017 PIPERACILLIN AND TAZOBACTAM
ANDA #065386		 SUPPL-11 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM HOSPIRA INC Labeling Approval
10/23/2017 PIPERACILLIN AND TAZOBACTAM
ANDA #065386		 SUPPL-13 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM HOSPIRA INC Labeling Approval
10/23/2017 PIPERACILLIN AND TAZOBACTAM
ANDA #065386		 SUPPL-14 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM HOSPIRA INC Labeling Approval
10/23/2017 FLUOCINONIDE
ANDA #072537		 SUPPL-26 FLUOCINONIDE COSETTE Manufacturing (CMC) Approval
10/23/2017 SEVELAMER CARBONATE
ANDA #090975		 ORIG-1 SEVELAMER CARBONATE IMPAX LABS INC Approval
10/23/2017 SOLIRIS
BLA #125166		 SUPPL-422 ECULIZUMAB ALEXION PHARM Approval
10/23/2017 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #205707		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM MICRO LABS LTD INDIA Labeling Approval
10/23/2017 LYNPARZA
NDA #206162		 SUPPL-8 OLAPARIB ASTRAZENECA Labeling Approval
10/23/2017 FINGOLIMOD
ANDA #207941		 ORIG-1 FINGOLIMOD FIRST TIME US GENERICS LLC Tentative Approval
10/23/2017 TESTOSTERONE
ANDA #208061		 ORIG-1 TESTOSTERONE LUPIN LTD Approval
10/23/2017 VIGABATRIN
ANDA #208218		 SUPPL-2 VIGABATRIN ENDO OPERATIONS REMS Approval
10/23/2017 CLONIDINE HYDROCHLORIDE
ANDA #209285		 ORIG-1 CLONIDINE HYDROCHLORIDE CHARTWELL RX Approval
10/23/2017 KLOR-CON
ANDA #209662		 ORIG-1 POTASSIUM CHLORIDE UPSHER SMITH LABS Approval
10/23/2017 OXYBUTYNIN CHLORIDE
ANDA #209823		 ORIG-1 OXYBUTYNIN CHLORIDE NOVITIUM PHARMA Approval
10/24/2017 KEPPRA
NDA #021035		 SUPPL-100 LEVETIRACETAM UCB INC Labeling Approval
10/24/2017 OXYTROL
NDA #021351		 SUPPL-17 OXYBUTYNIN ALLERGAN Labeling Approval
10/24/2017 OXYTROL
NDA #021351		 SUPPL-18 OXYBUTYNIN ALLERGAN Labeling Approval
10/24/2017 KEPPRA
NDA #021505		 SUPPL-40 LEVETIRACETAM UCB INC Labeling Approval
10/24/2017 KEPPRA
NDA #021872		 SUPPL-24 LEVETIRACETAM UCB INC Labeling Approval
10/24/2017 KEPPRA XR
NDA #022285		 SUPPL-26 LEVETIRACETAM UCB INC Labeling Approval
10/24/2017 TENOFOVIR DISOPROXIL FUMARATE
ANDA #091612		 SUPPL-2 TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Labeling Approval
10/24/2017 TENOFOVIR DISOPROXIL FUMARATE
ANDA #091612		 SUPPL-3 TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Labeling Approval
10/24/2017 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
ANDA #204383		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS LABS UT INC Tentative Approval
10/24/2017 ISOSORBIDE MONONITRATE
ANDA #209684		 ORIG-1 ISOSORBIDE MONONITRATE ACCORD HLTHCARE Approval
10/25/2017 KLONOPIN
NDA #017533		 SUPPL-59 CLONAZEPAM CHEPLAPHARM Labeling Approval
10/25/2017 FLORONE
NDA #017741		 SUPPL-24 DIFLORASONE DIACETATE PFIZER Labeling Approval
10/25/2017 PSORCON E
NDA #017994		 SUPPL-26 DIFLORASONE DIACETATE PFIZER Labeling Approval
10/25/2017 FLORONE E
NDA #019259		 SUPPL-12 DIFLORASONE DIACETATE PFIZER Labeling Approval
10/25/2017 PSORCON
NDA #019260		 SUPPL-9 DIFLORASONE DIACETATE PFIZER Labeling Approval
10/25/2017 GELNIQUE
NDA #022204		 SUPPL-10 OXYBUTYNIN CHLORIDE ABBVIE Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075273		 SUPPL-14 KETOCONAZOLE TEVA Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075273		 SUPPL-15 KETOCONAZOLE TEVA Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075314		 SUPPL-12 KETOCONAZOLE SUN PHARM INDUSTRIES Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075319		 SUPPL-6 KETOCONAZOLE TARO Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075319		 SUPPL-7 KETOCONAZOLE TARO Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075597		 SUPPL-7 KETOCONAZOLE AUROBINDO PHARMA USA Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075597		 SUPPL-8 KETOCONAZOLE AUROBINDO PHARMA USA Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075912		 SUPPL-8 KETOCONAZOLE SENORES PHARMS Labeling Approval
10/25/2017 KETOCONAZOLE
ANDA #075912		 SUPPL-9 KETOCONAZOLE SENORES PHARMS Labeling Approval
10/25/2017 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #078245		 SUPPL-23 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
10/25/2017 CARVEDILOL PHOSPHATE
ANDA #090132		 ORIG-1 CARVEDILOL PHOSPHATE SUN PHARM INDUSTRIES Approval
10/25/2017 REMICADE
BLA #103772		 SUPPL-5377 INFLIXIMAB CENTOCOR INC Approval
10/25/2017 KYNAMRO
NDA #203568		 SUPPL-9 MIPOMERSEN SODIUM KASTLE THERAPS LLC REMS Approval
10/25/2017 ZOLEDRONIC ACID
ANDA #204367		 SUPPL-1 ZOLEDRONIC ACID APOTEX Labeling Approval
10/25/2017 ZOLEDRONIC ACID
ANDA #204367		 SUPPL-2 ZOLEDRONIC ACID APOTEX Labeling Approval
10/25/2017 AMIODARONE HYDROCHLORIDE
ANDA #204550		 ORIG-1 AMIODARONE HYDROCHLORIDE EUGIA PHARMA Approval
10/25/2017 POTASSIUM ACETATE
ANDA #206203		 SUPPL-2 POTASSIUM ACETATE EXELA PHARMA Manufacturing (CMC) Approval
10/25/2017 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #206880		 ORIG-1 LEVETIRACETAM GLAND PHARMA LTD Approval
10/25/2017 VARUBI
NDA #208399		 ORIG-1 ROLAPITANT HYDROCHLORIDE TERSERA Type 3 - New Dosage Form Approval
10/25/2017 CLOBETASOL PROPIONATE
ANDA #209361		 ORIG-1 CLOBETASOL PROPIONATE MACLEODS PHARMS LTD Approval
10/26/2017 LOVENOX
NDA #020164		 SUPPL-110 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
10/26/2017 LOVENOX (PRESERVATIVE FREE)
NDA #020164		 SUPPL-110 ENOXAPARIN SODIUM SANOFI AVENTIS US Labeling Approval
10/26/2017 GABAPENTIN
ANDA #091008		 ORIG-1 GABAPENTIN CHARTWELL RX Approval
10/26/2017 OXYCODONE HYDROCHLORIDE
ANDA #203823		 SUPPL-3 OXYCODONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
10/26/2017 SEVELAMER CARBONATE
ANDA #203860		 ORIG-1 SEVELAMER CARBONATE INVAGEN PHARMS Approval
10/26/2017 OXACILLIN SODIUM
ANDA #206760		 ORIG-1 OXACILLIN SODIUM PIRAMAL CRITICAL Approval
10/26/2017 GABAPENTIN
ANDA #207057		 ORIG-1 GABAPENTIN CSPC OUYI Approval
10/26/2017 LEUCOVORIN CALCIUM PRESERVATIVE FREE
ANDA #209110		 ORIG-1 LEUCOVORIN CALCIUM SAGENT PHARMS INC Approval
10/27/2017 DIFLUCAN
NDA #019949		 SUPPL-67 FLUCONAZOLE PFIZER Labeling Approval
10/27/2017 DIFLUCAN
NDA #020090		 SUPPL-48 FLUCONAZOLE PFIZER Labeling Approval
10/27/2017 MUCINEX
NDA #021282		 SUPPL-49 GUAIFENESIN RB HLTH Manufacturing (CMC) Approval
10/27/2017 XARELTO
NDA #022406		 SUPPL-24 RIVAROXABAN JANSSEN PHARMS Efficacy Approval
10/27/2017 LACOSAMIDE
ANDA #205026		 ORIG-1 LACOSAMIDE MYLAN PHARMS INC Tentative Approval
10/27/2017 ZOLEDRONIC ACID
ANDA #205254		 ORIG-1 ZOLEDRONIC ACID MYLAN LABS LTD Approval
10/27/2017 ATAZANAVIR AND RITONAVIR
NDA #206451		 ORIG-1 ATAZANAVIR; RITONAVIR CIPLA Type 4 - New Combination Tentative Approval
10/27/2017 TAMOXIFEN CITRATE
ANDA #206694		 ORIG-1 TAMOXIFEN CITRATE ZYDUS PHARMS Approval
10/27/2017 METHADONE HYDROCHLORIDE
ANDA #208306		 ORIG-1 METHADONE HYDROCHLORIDE LONG GROVE PHARMS Approval
10/27/2017 GLYCOPYRROLATE
ANDA #209328		 ORIG-1 GLYCOPYRROLATE FRESENIUS KABI USA Approval
10/27/2017 CLOBETASOL PROPIONATE
ANDA #209871		 ORIG-1 CLOBETASOL PROPIONATE HIKMA Approval
10/27/2017 FLUOROURACIL
ANDA #210123		 ORIG-1 FLUOROURACIL GLAND PHARMA LTD Approval
10/27/2017 ZOLEDRONIC ACID
ANDA #210174		 ORIG-1 ZOLEDRONIC ACID AMNEAL Approval
10/27/2017 HYDROMORPHONE HYDROCHLORIDE
ANDA #210176		 ORIG-1 HYDROMORPHONE HYDROCHLORIDE ASCENT PHARMS INC Approval
10/27/2017 CLOBETASOL PROPIONATE
ANDA #210199		 ORIG-1 CLOBETASOL PROPIONATE ZYDUS PHARMS Approval
10/30/2017 NORVASC
NDA #019787		 SUPPL-62 AMLODIPINE BESYLATE VIATRIS Labeling Approval
10/30/2017 CADUET
NDA #021540		 SUPPL-38 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
10/30/2017 OMEPRAZOLE
NDA #022032		 SUPPL-37 OMEPRAZOLE DEXCEL PHARMA Labeling Approval
10/30/2017 ZEGERID OTC
NDA #022281		 SUPPL-12 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Labeling Approval
10/30/2017 ZEGERID OTC
NDA #022283		 SUPPL-2 OMEPRAZOLE; SODIUM BICARBONATE RILEY CONSUMER Labeling Approval
10/30/2017 DOXYCYCLINE
ANDA #065070		 SUPPL-25 DOXYCYCLINE STRIDES PHARMA Labeling Approval
10/30/2017 AMANTADINE HYDROCHLORIDE
ANDA #078720		 SUPPL-13 AMANTADINE HYDROCHLORIDE BIONPHARMA Manufacturing (CMC) Approval
10/30/2017 RASAGILINE MESYLATE
ANDA #201889		 ORIG-1 RASAGILINE MESYLATE ALKEM LABS LTD Approval
10/30/2017 SODIUM ACETATE
ANDA #206687		 ORIG-1 SODIUM ACETATE FRESENIUS KABI USA Approval
10/30/2017 LIDOCAINE HYDROCHLORIDE
ANDA #207182		 ORIG-1 LIDOCAINE HYDROCHLORIDE EUGIA PHARMA Approval
10/30/2017 DOXYCYCLINE HYCLATE
ANDA #207773		 ORIG-1 DOXYCYCLINE HYCLATE ZYDUS LIFESCIENCES Approval
10/30/2017 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #209116		 ORIG-1 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE AUROBINDO PHARMA Approval
10/30/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #210211		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Approval
10/31/2017 DILANTIN-125
NDA #008762		 SUPPL-60 PHENYTOIN VIATRIS Labeling Approval
10/31/2017 DILANTIN-125
NDA #008762		 SUPPL-61 PHENYTOIN VIATRIS Labeling Approval
10/31/2017 DILANTIN-30
NDA #008762		 SUPPL-60 PHENYTOIN VIATRIS Labeling Approval
10/31/2017 DILANTIN-30
NDA #008762		 SUPPL-61 PHENYTOIN VIATRIS Labeling Approval
10/31/2017 DILANTIN
NDA #010151		 SUPPL-47 PHENYTOIN SODIUM PARKE DAVIS Labeling Approval
10/31/2017 DILANTIN
NDA #010151		 SUPPL-48 PHENYTOIN SODIUM PARKE DAVIS Labeling Approval
10/31/2017 CEREBYX
NDA #020450		 SUPPL-37 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
10/31/2017 CEREBYX
NDA #020450		 SUPPL-38 FOSPHENYTOIN SODIUM PARKE DAVIS Labeling Approval
10/31/2017 PLAVIX
NDA #020839		 SUPPL-68 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Labeling Approval
10/31/2017 MIDAZOLAM HYDROCHLORIDE
ANDA #076144		 SUPPL-3 MIDAZOLAM HYDROCHLORIDE INTL MEDICATED Labeling Approval
10/31/2017 CIPROFLOXACIN
ANDA #076593		 SUPPL-3 CIPROFLOXACIN AIPING PHARM INC Labeling Approval
10/31/2017 CIPROFLOXACIN
ANDA #076593		 SUPPL-4 CIPROFLOXACIN AIPING PHARM INC Labeling Approval
10/31/2017 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076593		 SUPPL-3 CIPROFLOXACIN HYDROCHLORIDE AIPING PHARM INC Labeling Approval
10/31/2017 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076593		 SUPPL-4 CIPROFLOXACIN HYDROCHLORIDE AIPING PHARM INC Labeling Approval
10/31/2017 FOSPHENYTOIN SODIUM
ANDA #078126		 SUPPL-9 FOSPHENYTOIN SODIUM APOTEX INC Labeling Approval
10/31/2017 FOSPHENYTOIN SODIUM
ANDA #078126		 SUPPL-10 FOSPHENYTOIN SODIUM APOTEX INC Labeling Approval
10/31/2017 MIDAZOLAM HYDROCHLORIDE
ANDA #090850		 SUPPL-9 MIDAZOLAM HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
10/31/2017 ACETYLCYSTEINE
ANDA #091684		 ORIG-1 ACETYLCYSTEINE SAGENT PHARMS INC Approval
10/31/2017 ARANESP
BLA #103951		 SUPPL-5374 DARBEPOETIN ALFA AMGEN Approval
10/31/2017 ETOPOSIDE
ANDA #204927		 ORIG-1 ETOPOSIDE DASH PHARMS Approval
10/31/2017 METFORMIN HYDROCHLORIDE
ANDA #205330		 ORIG-1 METFORMIN HYDROCHLORIDE MACLEODS PHARMS LTD Approval
10/31/2017 DEXTROAMPHETAMINE SULFATE
ANDA #205673		 ORIG-1 DEXTROAMPHETAMINE SULFATE STRIDES PHARMA Approval
10/31/2017 IBANDRONATE SODIUM
ANDA #206887		 ORIG-1 IBANDRONATE SODIUM MACLEODS PHARMS LTD Approval
10/31/2017 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #207340		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ZYDUS PHARMS Approval
10/31/2017 TAGRISSO
NDA #208065		 SUPPL-7 OSIMERTINIB MESYLATE ASTRAZENECA Labeling Approval
10/31/2017 OSELTAMIVIR PHOSPHATE
ANDA #208823		 ORIG-1 OSELTAMIVIR PHOSPHATE ALVOGEN Approval
10/31/2017 CALQUENCE
NDA #210259		 ORIG-1 ACALABRUTINIB ASTRAZENECA Type 1 - New Molecular Entity Approval
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