U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
August 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 19, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/01/2018 VASOTEC
NDA #018998		 SUPPL-83 ENALAPRIL MALEATE BAUSCH Labeling Approval
08/01/2018 DEPO-TESTOSTERONE
ANDA #085635		 SUPPL-40 TESTOSTERONE CYPIONATE PFIZER Labeling Approval
08/01/2018 ROCURONIUM BROMIDE
ANDA #091115		 SUPPL-9 ROCURONIUM BROMIDE TAMARANG Labeling Approval
08/01/2018 OXACILLIN SODIUM
ANDA #201539		 SUPPL-7 OXACILLIN SODIUM EUGIA PHARMA SPECLTS Manufacturing (CMC) Approval
08/01/2018 VANCOMYCIN HYDROCHLORIDE
ANDA #204125		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Labeling Approval
08/01/2018 CABERGOLINE
ANDA #204735		 ORIG-1 CABERGOLINE INGENUS PHARMS LLC Approval
08/01/2018 GENVOYA
NDA #207561		 SUPPL-17 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
08/01/2018 RANITIDINE HYDROCHLORIDE
ANDA #210010		 ORIG-1 RANITIDINE HYDROCHLORIDE STRIDES PHARMA Approval
08/01/2018 CINACALCET HYDROCHLORIDE
ANDA #210207		 ORIG-1 CINACALCET HYDROCHLORIDE SLATE RUN PHARMA Approval
08/02/2018 ADVIL LIQUI-GELS
NDA #020402		 SUPPL-46 IBUPROFEN HALEON US HOLDINGS Labeling Approval
08/02/2018 ADVIL MIGRAINE LIQUI-GELS
NDA #020402		 SUPPL-46 IBUPROFEN HALEON US HOLDINGS Labeling Approval
08/02/2018 VALCYTE
NDA #021304		 SUPPL-14 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Efficacy Approval
08/02/2018 DOCETAXEL
NDA #022234		 SUPPL-10 DOCETAXEL HOSPIRA INC Labeling Approval
08/02/2018 VALCYTE
NDA #022257		 SUPPL-9 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Efficacy Approval
08/02/2018 HUMIRA
BLA #125057		 SUPPL-406 ADALIMUMAB ABBVIE INC Approval
08/02/2018 METHADONE HYDROCHLORIDE
ANDA #210484		 ORIG-1 METHADONE HYDROCHLORIDE NOSTRUM LABS INC Approval
08/02/2018 TIGECYCLINE
NDA #211158		 ORIG-1 TIGECYCLINE AMNEAL Type 5 - New Formulation or New Manufacturer Approval
08/03/2018 TADALAFIL
ANDA #200630		 ORIG-1 TADALAFIL MYLAN Approval
08/03/2018 STENDRA
NDA #202276		 SUPPL-18 AVANAFIL METUCHEN PHARMS Efficacy Approval
08/03/2018 NUVESSA
NDA #205223		 SUPPL-2 METRONIDAZOLE CHEMO RESEARCH SL Efficacy Approval
08/03/2018 JADENU
NDA #206910		 SUPPL-10 DEFERASIROX NOVARTIS PHARMS CORP Labeling Approval
08/03/2018 JADENU SPRINKLE
NDA #207968		 SUPPL-5 DEFERASIROX NOVARTIS Labeling Approval
08/03/2018 LIDOCAINE HYDROCHLORIDE
ANDA #208474		 ORIG-1 LIDOCAINE HYDROCHLORIDE B BRAUN MEDICAL INC Approval
08/03/2018 DICLOFENAC SODIUM
ANDA #209903		 ORIG-1 DICLOFENAC SODIUM CIPLA Approval
08/06/2018 GALLIUM CITRATE GA 67
NDA #017478		 SUPPL-16 GALLIUM CITRATE GA-67 LANTHEUS MEDCL Labeling Approval
08/06/2018 CYTOVENE
NDA #019661		 SUPPL-37 GANCICLOVIR SODIUM CHEPLAPHARM Efficacy Approval
08/06/2018 PRIMAXIN
NDA #050587		 SUPPL-80 CILASTATIN SODIUM; IMIPENEM MERCK Manufacturing (CMC) Approval
08/06/2018 ROFLUMILAST
ANDA #208272		 ORIG-1 ROFLUMILAST TORRENT Approval
08/06/2018 MAVYRET
NDA #209394		 SUPPL-2 GLECAPREVIR; PIBRENTASVIR ABBVIE Efficacy Approval
08/07/2018 KETALAR
NDA #016812		 SUPPL-40 KETAMINE HYDROCHLORIDE PAR STERILE PRODUCTS Labeling Approval
08/07/2018 STRIBILD
NDA #203100		 SUPPL-32 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
08/07/2018 TOLCAPONE
ANDA #208937		 ORIG-1 TOLCAPONE NOVAST LABS Approval
08/07/2018 AXITINIB
ANDA #210234		 ORIG-1 AXITINIB TEVA PHARMS Tentative Approval
08/07/2018 ORKAMBI
NDA #211358		 ORIG-1 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Type 3 - New Dosage Form Approval
08/08/2018 LASIX
NDA #016273		 SUPPL-69 FUROSEMIDE VALIDUS PHARMS Labeling Approval
08/08/2018 BUMEX
NDA #018225		 SUPPL-28 BUMETANIDE VALIDUS PHARMS Labeling Approval
08/08/2018 LOTENSIN HCT
NDA #020033		 SUPPL-62 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE VALIDUS PHARMS Labeling Approval
08/08/2018 SOLUPREP S
NDA #208288		 ORIG-1 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3M HEALTH CARE Type 5 - New Formulation or New Manufacturer Approval
08/08/2018 JORNAY PM
NDA #209311		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE IRONSHORE PHARMS Type 3 - New Dosage Form Approval
08/08/2018 ARAKODA
NDA #210607		 ORIG-1 TAFENOQUINE SUCCINATE 60 DEGREES PHARMS Type 5 - New Formulation or New Manufacturer Approval
08/08/2018 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #210880		 ORIG-1 DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE HETERO LABS UNIT III Type 4 - New Combination Tentative Approval
08/08/2018 POTASSIUM CHLORIDE
ANDA #211067		 ORIG-1 POTASSIUM CHLORIDE APOTEX Approval
08/08/2018 POTELIGEO
BLA #761051		 ORIG-1 MOGAMULIZUMAB-KPKC KYOWA KIRIN Approval
08/09/2018 ATAZANAVIR SULFATE
ANDA #200626		 ORIG-1 ATAZANAVIR SULFATE CIPLA Approval
08/09/2018 DICLOFENAC SODIUM
ANDA #202769		 SUPPL-1 DICLOFENAC SODIUM PAI HOLDINGS PHARM Labeling Approval
08/09/2018 RYZODEG 70/30
BLA #203313		 SUPPL-5 INSULIN ASPART; INSULIN DEGLUDEC NOVO Approval
08/09/2018 TRESIBA
BLA #203314		 SUPPL-9 INSULIN DEGLUDEC NOVO Approval
08/09/2018 METHOTREXATE SODIUM PRESERVATIVE FREE
ANDA #203407		 ORIG-1 METHOTREXATE SODIUM SAGENT PHARMS INC Approval
08/09/2018 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
ANDA #208328		 SUPPL-1 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE AMNEAL PHARMS Manufacturing (CMC) Tentative Approval
08/09/2018 NETSPOT
NDA #208547		 SUPPL-13 GALLIUM DOTATATE GA-68 AAA USA INC Manufacturing (CMC) Approval
08/09/2018 ESTRADIOL
ANDA #210194		 SUPPL-2 ESTRADIOL PADAGIS ISRAEL Labeling Approval
08/09/2018 ESTRADIOL
ANDA #210488		 SUPPL-1 ESTRADIOL TEVA PHARMS USA Labeling Approval
08/09/2018 LARTRUVO
BLA #761038		 SUPPL-9 OLARATUMAB ELI LILLY AND CO Approval
08/10/2018 HIBICLENS
NDA #017768		 SUPPL-48 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Manufacturing (CMC) Approval
08/10/2018 GLUCOTROL XL
NDA #020329		 SUPPL-32 GLIPIZIDE PFIZER Labeling Approval
08/10/2018 LIPITOR
NDA #020702		 SUPPL-71 ATORVASTATIN CALCIUM UPJOHN Labeling Approval
08/10/2018 NICORETTE
NDA #021330		 SUPPL-21 NICOTINE POLACRILEX HALEON US HOLDINGS Manufacturing (CMC) Approval
08/10/2018 ZORTRESS
NDA #021560		 SUPPL-22 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
08/10/2018 NEXIUM IV
NDA #021689		 SUPPL-33 ESOMEPRAZOLE SODIUM ASTRAZENECA Labeling Approval
08/10/2018 MOMETASONE FUROATE
ANDA #078541		 SUPPL-11 MOMETASONE FUROATE GLENMARK PHARMS INC Labeling Approval
08/10/2018 INLYTA
NDA #202324		 SUPPL-8 AXITINIB PF PRISM CV Labeling Approval
08/10/2018 PIPERACILLIN AND TAZOBACTAM
ANDA #204959		 ORIG-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SHANDONG Approval
08/10/2018 AKOVAZ
NDA #208289		 SUPPL-2 EPHEDRINE SULFATE EXELA PHARMA Labeling Approval
08/10/2018 GALAFOLD
NDA #208623		 ORIG-1 MIGALASTAT HYDROCHLORIDE AMICUS THERAP US Type 1 - New Molecular Entity Approval
08/10/2018 INGREZZA
NDA #209241		 SUPPL-3 VALBENAZINE TOSYLATE NEUROCRINE Labeling Approval
08/10/2018 SODIUM NITROPRUSSIDE
ANDA #209584		 ORIG-1 SODIUM NITROPRUSSIDE MYLAN Approval
08/10/2018 ANNOVERA
NDA #209627		 ORIG-1 ETHINYL ESTRADIOL; SEGESTERONE ACETATE MAYNE PHARMA Type 1 - New Molecular Entity and Type 4 - New Combination Approval
08/10/2018 ONPATTRO
NDA #210922		 ORIG-1 PATISIRAN SODIUM ALNYLAM PHARMS INC Type 1 - New Molecular Entity Approval
08/13/2018 VENLAFAXINE HYDROCHLORIDE
ANDA #204889		 SUPPL-1 VENLAFAXINE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
08/13/2018 LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE
NDA #205626		 ORIG-1 LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE MICRO LABS Type 4 - New Combination Approval
08/13/2018 IMATINIB MESYLATE
ANDA #206547		 ORIG-1 IMATINIB MESYLATE DR REDDYS Approval
08/13/2018 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #210137		 ORIG-1 FEXOFENADINE HYDROCHLORIDE UNIQUE Approval
08/14/2018 CYRAMZA
BLA #125477		 SUPPL-30 RAMUCIRUMAB ELI LILLY AND CO Approval
08/14/2018 ESTRADIOL
ANDA #201675		 SUPPL-5 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
08/14/2018 ESTRADIOL
ANDA #201675		 SUPPL-6 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
08/14/2018 CEQUA
NDA #210913		 ORIG-1 CYCLOSPORINE SUN PHARM Type 5 - New Formulation or New Manufacturer Approval
08/15/2018 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
NDA #022343		 ORIG-1 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Type 4 - New Combination Approval
08/15/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040432		 SUPPL-10 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040482		 SUPPL-18 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
08/15/2018 COSMEGEN
NDA #050682		 SUPPL-33 DACTINOMYCIN RECORDATI RARE Efficacy Approval
08/15/2018 COSMEGEN
NDA #050682		 SUPPL-34 DACTINOMYCIN RECORDATI RARE Efficacy Approval
08/15/2018 NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
ANDA #074736		 SUPPL-32 NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE WATSON LABS Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-20 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-22 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076642		 SUPPL-23 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 REPREXAIN
ANDA #076642		 SUPPL-20 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 REPREXAIN
ANDA #076642		 SUPPL-22 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 REPREXAIN
ANDA #076642		 SUPPL-23 HYDROCODONE BITARTRATE; IBUPROFEN AMNEAL PHARMS NY Labeling Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #077454		 SUPPL-1 HYDROCODONE BITARTRATE; IBUPROFEN ANI PHARMS Labeling Approval
08/15/2018 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078769		 SUPPL-20 IBUPROFEN; OXYCODONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
08/15/2018 ESTRACE
ANDA #086069		 SUPPL-24 ESTRADIOL ALLERGAN Labeling Approval
08/15/2018 PREPOPIK
NDA #202535		 SUPPL-5 CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE FERRING PHARMS INC Efficacy Approval
08/15/2018 KALYDECO
NDA #203188		 SUPPL-28 IVACAFTOR VERTEX PHARMS Efficacy Approval
08/15/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #204575		 SUPPL-1 HYDROCODONE BITARTRATE; IBUPROFEN AUROLIFE PHARMA LLC Labeling Approval
08/15/2018 ATRACURIUM BESYLATE
ANDA #206011		 SUPPL-2 ATRACURIUM BESYLATE EUGIA PHARMA Labeling Approval
08/15/2018 ORKAMBI
NDA #206038		 SUPPL-10 IVACAFTOR; LUMACAFTOR VERTEX PHARMS INC Labeling Approval
08/15/2018 ESTRADIOL
ANDA #206685		 ORIG-1 ESTRADIOL MYLAN TECHNOLOGIES Approval
08/15/2018 LENVIMA
NDA #206947		 SUPPL-7 LENVATINIB MESYLATE EISAI INC Efficacy Approval
08/15/2018 KALYDECO
NDA #207925		 SUPPL-7 IVACAFTOR VERTEX PHARMS INC Efficacy Approval
08/15/2018 ESTRADIOL
ANDA #209767		 SUPPL-1 ESTRADIOL ALVOGEN Labeling Approval
08/16/2018 ABRAXANE
NDA #021660		 SUPPL-45 PACLITAXEL BRISTOL-MYERS Labeling Approval
08/16/2018 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076631		 SUPPL-32 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE SANDOZ Labeling Approval
08/16/2018 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076688		 SUPPL-15 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE AUROBINDO PHARMA USA Labeling Approval
08/16/2018 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078794		 SUPPL-4 BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE APOTEX Labeling Approval
08/16/2018 EPINEPHRINE (AUTOINJECTOR)
ANDA #090589		 ORIG-1 EPINEPHRINE TEVA PHARMS USA Approval
08/16/2018 EYLEA
BLA #125387		 SUPPL-56 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
08/16/2018 EYLEA
BLA #125387		 SUPPL-58 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
08/16/2018 KEYTRUDA
BLA #125514		 SUPPL-46 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/16/2018 OPDIVO
BLA #125554		 SUPPL-67 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
08/16/2018 LOPINAVIR; RITONAVIR
NDA #210540		 ORIG-1 LOPINAVIR; RITONAVIR MYLAN LABS LTD Type 5 - New Formulation or New Manufacturer Tentative Approval
08/16/2018 KETOROLAC TROMETHAMINE
ANDA #210616		 ORIG-1 KETOROLAC TROMETHAMINE CHARTWELL RX Approval
08/17/2018 MIRALAX
NDA #022015		 SUPPL-33 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
08/17/2018 DIVIGEL
NDA #022038		 SUPPL-4 ESTRADIOL VERTICAL PHARMS Efficacy Approval
08/17/2018 XELJANZ
NDA #203214		 SUPPL-21 TOFACITINIB CITRATE PF PRISM CV Labeling Approval
08/17/2018 PACLITAXEL
ANDA #205720		 ORIG-1 PACLITAXEL ACCORD HLTHCARE Approval
08/17/2018 XELJANZ XR
NDA #208246		 SUPPL-7 TOFACITINIB CITRATE PFIZER Labeling Approval
08/17/2018 VERZENIO
NDA #208716		 SUPPL-1 ABEMACICLIB ELI LILLY AND CO Labeling Approval
08/17/2018 RADICAVA
NDA #209176		 SUPPL-5 EDARAVONE MITSUBISHI TANABE Manufacturing (CMC) Approval
08/17/2018 IBUPROFEN
ANDA #210149		 ORIG-1 IBUPROFEN GUARDIAN DRUG Approval
08/17/2018 HYDROCORTISONE BUTYRATE
ANDA #210209		 ORIG-1 HYDROCORTISONE BUTYRATE LUPIN LTD Approval
08/17/2018 FENOFIBRATE
ANDA #210606		 ORIG-1 FENOFIBRATE GRAVITI PHARMS Approval
08/17/2018 SODIUM NITROPRUSSIDE
ANDA #210882		 ORIG-1 SODIUM NITROPRUSSIDE SOMERSET THERAPS LLC Approval
08/20/2018 FROVA
NDA #021006		 SUPPL-22 FROVATRIPTAN SUCCINATE ENDO PHARMS Labeling Approval
08/20/2018 KEYTRUDA
BLA #125514		 SUPPL-35 PEMBROLIZUMAB MERCK SHARP DOHME Approval
08/20/2018 DIACOMIT
NDA #206709		 ORIG-1 STIRIPENTOL BIOCODEX SA Type 1 - New Molecular Entity Approval
08/20/2018 DIACOMIT
NDA #207223		 ORIG-1 STIRIPENTOL BIOCODEX SA Type 3 - New Dosage Form Approval
08/20/2018 PARSABIV
NDA #208325		 SUPPL-1 ETELCALCETIDE KAI PHARMS INC Labeling Approval
08/20/2018 RANITIDINE HYDROCHLORIDE
ANDA #210243		 ORIG-1 RANITIDINE HYDROCHLORIDE GRANULES Approval
08/21/2018 PROGESTERONE
NDA #017362		 SUPPL-111 PROGESTERONE ACTAVIS LABS UT INC Labeling Approval
08/21/2018 SABRIL
NDA #020427		 SUPPL-18 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
08/21/2018 GLEEVEC
NDA #021588		 SUPPL-53 IMATINIB MESYLATE NOVARTIS Labeling Approval
08/21/2018 SABRIL
NDA #022006		 SUPPL-20 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
08/21/2018 PRILOSEC
NDA #022056		 SUPPL-21 OMEPRAZOLE MAGNESIUM COVIS Labeling Approval
08/21/2018 TASIGNA
NDA #022068		 SUPPL-29 NILOTINIB HYDROCHLORIDE NOVARTIS Labeling Approval
08/21/2018 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208532		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE BAXTER HLTHCARE CORP Approval
08/21/2018 ASPIRIN AND DIPYRIDAMOLE
ANDA #208572		 ORIG-1 ASPIRIN; DIPYRIDAMOLE SUN PHARM Approval
08/21/2018 CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
ANDA #209408		 ORIG-1 CEFEPIME HYDROCHLORIDE SAMSON MEDCL Approval
08/21/2018 CLOBETASOL PROPIONATE
ANDA #210551		 ORIG-1 CLOBETASOL PROPIONATE AMNEAL Approval
08/21/2018 FLUOCINONIDE
ANDA #210554		 ORIG-1 FLUOCINONIDE AMNEAL Approval
08/22/2018 SOMA
NDA #011792		 SUPPL-48 CARISOPRODOL MYLAN SPECIALITY LP Labeling Approval
08/22/2018 ANAFRANIL
NDA #019906		 SUPPL-41 CLOMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
08/22/2018 DANAZOL
ANDA #074582		 SUPPL-31 DANAZOL BARR Labeling Approval
08/22/2018 DANAZOL
ANDA #077246		 SUPPL-14 DANAZOL LANNETT CO INC Labeling Approval
08/22/2018 PRALUENT
BLA #125559		 SUPPL-14 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
08/22/2018 DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #205723		 ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE MICRO LABS Approval
08/22/2018 LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473		 SUPPL-2 LINEZOLID HOSPIRA Labeling Approval
08/22/2018 IRESSA
NDA #206995		 SUPPL-3 GEFITINIB ASTRAZENECA Labeling Approval
08/22/2018 GLEOLAN
NDA #208630		 SUPPL-3 AMINOLEVULINIC ACID HYDROCHLORIDE NXDC Labeling Approval
08/22/2018 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #208689		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE AMNEAL Approval
08/22/2018 DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
ANDA #208690		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE AMNEAL Approval
08/22/2018 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #209721		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE AMNEAL PHARMS CO Approval
08/22/2018 INVELTYS
NDA #210565		 ORIG-1 LOTEPREDNOL ETABONATE ALCON LABS INC Type 5 - New Formulation or New Manufacturer Approval
08/22/2018 NEOSTIGMINE METHYLSULFATE
ANDA #210989		 ORIG-1 NEOSTIGMINE METHYLSULFATE AMRING PHARMS Approval
08/22/2018 OXERVATE
BLA #761094		 ORIG-1 CENEGERMIN-BKBJ DOMPE FARMACEUTICI Approval
08/23/2018 EPI E Z PEN JR
NDA #019430		 SUPPL-74 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
08/23/2018 EPIPEN
NDA #019430		 SUPPL-74 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
08/23/2018 EPIPEN E Z PEN
NDA #019430		 SUPPL-74 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
08/23/2018 EPIPEN JR.
NDA #019430		 SUPPL-74 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
08/23/2018 CELLCEPT
NDA #050722		 SUPPL-35 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
08/23/2018 CELLCEPT
NDA #050723		 SUPPL-35 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
08/23/2018 CELLCEPT
NDA #050758		 SUPPL-33 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO Labeling Approval
08/23/2018 CELLCEPT
NDA #050759		 SUPPL-41 MYCOPHENOLATE MOFETIL ROCHE PALO Labeling Approval
08/23/2018 TICAGRELOR
ANDA #208539		 ORIG-1 TICAGRELOR MICRO LABS LTD Tentative Approval
08/23/2018 ALTRENO
NDA #209353		 ORIG-1 TRETINOIN DOW PHARM Type 3 - New Dosage Form Approval
08/23/2018 TAKHZYRO
BLA #761090		 ORIG-1 LANADELUMAB-FLYO DYAX CORP. Approval
08/24/2018 LANOXIN
NDA #009330		 SUPPL-34 DIGOXIN COVIS Labeling Approval
08/24/2018 LANOXIN PEDIATRIC
NDA #009330		 SUPPL-34 DIGOXIN COVIS Labeling Approval
08/24/2018 LANOXIN
NDA #020405		 SUPPL-14 DIGOXIN CONCORDIA Labeling Approval
08/24/2018 DIGOXIN
NDA #021648		 SUPPL-11 DIGOXIN HIKMA Labeling Approval
08/24/2018 ESTRADIOL
ANDA #040197		 SUPPL-27 ESTRADIOL BARR LABS INC Labeling Approval
08/24/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #040608		 SUPPL-12 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MIKART Labeling Approval
08/24/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040658		 SUPPL-11 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
08/24/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040846		 SUPPL-10 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
08/24/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040881		 SUPPL-9 ACETAMINOPHEN; HYDROCODONE BITARTRATE MIKART Labeling Approval
08/24/2018 CEFOTETAN
ANDA #065374		 SUPPL-8 CEFOTETAN DISODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
08/24/2018 TRAMADOL HYDROCHLORIDE
ANDA #200503		 SUPPL-6 TRAMADOL HYDROCHLORIDE LUPIN LTD Labeling Approval
08/24/2018 TRAMADOL HYDROCHLORIDE
ANDA #205257		 SUPPL-5 TRAMADOL HYDROCHLORIDE MYLAN Labeling Approval
08/24/2018 IMBRUVICA
NDA #205552		 SUPPL-24 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
08/24/2018 IMBRUVICA
NDA #205552		 SUPPL-25 IBRUTINIB PHARMACYCLICS LLC Labeling Approval
08/24/2018 IBUPROFEN
ANDA #209207		 SUPPL-4 IBUPROFEN TARO Manufacturing (CMC) Approval
08/24/2018 GABAPENTIN
ANDA #209306		 ORIG-1 GABAPENTIN LUPIN LTD Approval
08/24/2018 ITRACONAZOLE
ANDA #209460		 ORIG-1 ITRACONAZOLE TORRENT Approval
08/24/2018 DOCETAXEL
ANDA #209634		 ORIG-1 DOCETAXEL MEITHEAL Approval
08/24/2018 IMBRUVICA
NDA #210563		 SUPPL-1 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
08/24/2018 OXYGEN, USP
NDA #212314		 ORIG-1 OXYGEN UNIVERSAL INDUSTRIAL GASES, INC Medical Gas Approval
08/24/2018 NITROGEN, NF
NDA #212315		 ORIG-1 NITROGEN, NF UNIVERSAL INDUSTRIAL GASES, INC Medical Gas Approval
08/26/2018 CARBATROL
NDA #020712		 SUPPL-36 CARBAMAZEPINE TAKEDA PHARMS USA Labeling Approval
08/27/2018 CEFOTETAN
ANDA #065374		 SUPPL-4 CEFOTETAN DISODIUM FRESENIUS KABI USA Labeling Approval
08/27/2018 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #076313		 SUPPL-12 OCTREOTIDE ACETATE WEST-WARD PHARMS INT Labeling Approval
08/27/2018 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #076313		 SUPPL-13 OCTREOTIDE ACETATE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
08/27/2018 OCTREOTIDE ACETATE
ANDA #076330		 SUPPL-13 OCTREOTIDE ACETATE WEST-WARD PHARMS INT Labeling Approval
08/27/2018 ESTRADIOL
ANDA #208788		 SUPPL-2 ESTRADIOL MYLAN Labeling Approval
08/27/2018 METFORMIN HYDROCHLORIDE
ANDA #209882		 ORIG-1 METFORMIN HYDROCHLORIDE LAURUS Approval
08/27/2018 XERAVA
NDA #211109		 ORIG-1 ERAVACYCLINE DIHYDROCHLORIDE TETRAPHASE PHARMS Type 1 - New Molecular Entity Approval
08/28/2018 ALEVE
NDA #020204		 SUPPL-58 NAPROXEN SODIUM BAYER Labeling Approval
08/28/2018 ARIPIPRAZOLE
ANDA #090165		 ORIG-1 ARIPIPRAZOLE SQUARE PHARMS Approval
08/28/2018 LOSARTAN POTASSIUM
ANDA #201170		 SUPPL-9 LOSARTAN POTASSIUM JUBILANT CADISTA Manufacturing (CMC) Approval
08/28/2018 GEMFIBROZIL
ANDA #204189		 ORIG-1 GEMFIBROZIL CADILA Approval
08/28/2018 LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
NDA #205054		 ORIG-1 LEUPROLIDE ACETATE INVAGEN PHARMS Type 5 - New Formulation or New Manufacturer Approval
08/28/2018 ALEVE PM
NDA #205352		 SUPPL-11 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
08/28/2018 TAGRISSO
NDA #208065		 SUPPL-11 OSIMERTINIB MESYLATE ASTRAZENECA Labeling Approval
08/28/2018 ALOGLIPTIN
ANDA #210240		 ORIG-1 ALOGLIPTIN HETERO USA INC Tentative Approval
08/28/2018 FENOFIBRATE
ANDA #211080		 ORIG-1 FENOFIBRATE PRINSTON INC Approval
08/29/2018 ADRENACLICK
NDA #020800		 SUPPL-35 EPINEPHRINE IMPAX Labeling Approval
08/29/2018 TWINJECT 0.15
NDA #020800		 SUPPL-35 EPINEPHRINE IMPAX Labeling Approval
08/29/2018 TWINJECT 0.3
NDA #020800		 SUPPL-35 EPINEPHRINE IMPAX Labeling Approval
08/29/2018 VUSION
NDA #021026		 SUPPL-13 MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE MYLAN Labeling Approval
08/29/2018 LAMIVUDINE AND ZIDOVUDINE
ANDA #090679		 ORIG-1 LAMIVUDINE; ZIDOVUDINE MACLEODS PHARMS LTD Approval
08/29/2018 CERDELGA
NDA #205494		 SUPPL-3 ELIGLUSTAT TARTRATE GENZYME CORP Efficacy Approval
08/29/2018 POTASSIUM CHLORIDE
ANDA #209786		 ORIG-1 POTASSIUM CHLORIDE NOVEL LABS INC Approval
08/29/2018 ISOSORBIDE MONONITRATE
ANDA #210822		 ORIG-1 ISOSORBIDE MONONITRATE DEXCEL LTD Approval
08/30/2018 CHILDREN'S ADVIL
NDA #020589		 SUPPL-37 IBUPROFEN HALEON US HOLDINGS Labeling Approval
08/30/2018 CHILDREN'S ADVIL-FLAVORED
NDA #020589		 SUPPL-37 IBUPROFEN HALEON US HOLDINGS Labeling Approval
08/30/2018 FLECTOR
NDA #021234		 SUPPL-15 DICLOFENAC EPOLAMINE IBSA Labeling Approval
08/30/2018 HYDROCODONE BITARTRATE AND IBUPROFEN
ANDA #076023		 SUPPL-17 HYDROCODONE BITARTRATE; IBUPROFEN TEVA Labeling Approval
08/30/2018 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #205131		 SUPPL-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Labeling Approval
08/30/2018 DILTIAZEM HYDROCHLORIDE
ANDA #205231		 ORIG-1 DILTIAZEM HYDROCHLORIDE TWI PHARMS Approval
08/30/2018 EFAVIRENZ
ANDA #205322		 ORIG-1 EFAVIRENZ AUROBINDO PHARMA Approval
08/30/2018 DAPTOMYCIN
NDA #208385		 SUPPL-1 DAPTOMYCIN SAGENT PHARMS INC Labeling Approval
08/30/2018 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #209600		 ORIG-1 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL ACCORD HLTHCARE INC Approval
08/30/2018 PIFELTRO
NDA #210806		 ORIG-1 DORAVIRINE MSD MERCK CO Type 1 - New Molecular Entity Approval
08/30/2018 DELSTRIGO
NDA #210807		 ORIG-1 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MSD MERCK CO Type 4 - New Combination Approval
08/31/2018 ADVIL LIQUI-GELS
NDA #020402		 SUPPL-47 IBUPROFEN HALEON US HOLDINGS Labeling Approval
08/31/2018 ADVIL MIGRAINE LIQUI-GELS
NDA #020402		 SUPPL-47 IBUPROFEN HALEON US HOLDINGS Labeling Approval
08/31/2018 ABSORICA
NDA #021951		 SUPPL-14 ISOTRETINOIN SUN PHARM INDS INC Labeling Approval
08/31/2018 AMNESTEEM
ANDA #075945		 SUPPL-37 ISOTRETINOIN MYLAN PHARMS INC Labeling Approval
08/31/2018 CLARAVIS
ANDA #076135		 SUPPL-43 ISOTRETINOIN TEVA PHARMS USA Labeling Approval
08/31/2018 CLARAVIS
ANDA #076356		 SUPPL-40 ISOTRETINOIN TEVA PHARMS USA Labeling Approval
08/31/2018 MYORISAN
ANDA #076485		 SUPPL-21 ISOTRETINOIN UPSHER SMITH LABS Labeling Approval
08/31/2018 BETASERON
BLA #103471		 SUPPL-5193 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
08/31/2018 ZENATANE
ANDA #202099		 SUPPL-15 ISOTRETINOIN DR REDDYS LABS LTD Labeling Approval
08/31/2018 XOFIGO
NDA #203971		 SUPPL-14 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Labeling Approval
08/31/2018 BELRAPZO
NDA #205580		 SUPPL-2 BENDAMUSTINE HYDROCHLORIDE EAGLE PHARMS Labeling Approval
08/31/2018 ACYCLOVIR SODIUM
ANDA #206535		 ORIG-1 ACYCLOVIR SODIUM ZYDUS PHARMS Approval
08/31/2018 ISOTRETINOIN
ANDA #207792		 SUPPL-5 ISOTRETINOIN AMNEAL PHARMS NY Labeling Approval
08/31/2018 ARSENIC TRIOXIDE
ANDA #208231		 ORIG-1 ARSENIC TRIOXIDE FRESENIUS KABI USA Approval
08/31/2018 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #210571		 ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE UPSHER SMITH LABS Approval
08/31/2018 POTASSIUM CHLORIDE
ANDA #210733		 ORIG-1 POTASSIUM CHLORIDE STRIDES PHARMA Approval
Back to Top