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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 2015

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on December 06, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/01/2015 ALDACTONE
NDA #012151		 SUPPL-73 SPIRONOLACTONE PFIZER Manufacturing (CMC) Approval
05/01/2015 ORTHO CYCLEN-21
NDA #019653		 SUPPL-56 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
05/01/2015 ORTHO CYCLEN-28
NDA #019653		 SUPPL-56 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
05/01/2015 ORTHO TRI-CYCLEN
NDA #019697		 SUPPL-52 ETHINYL ESTRADIOL; NORGESTIMATE JANSSEN PHARMS Labeling Approval
05/01/2015 ORTHO TRI-CYCLEN 21
NDA #021690		 SUPPL-1 ETHINYL ESTRADIOL; NORGESTIMATE ORTHO MCNEIL PHARM Labeling Approval
05/01/2015 ORTHO TRI-CYCLEN 28
NDA #021690		 SUPPL-1 ETHINYL ESTRADIOL; NORGESTIMATE ORTHO MCNEIL PHARM Labeling Approval
05/01/2015 GILENYA
NDA #022527		 SUPPL-13 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
05/01/2015 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
NDA #050780		 SUPPL-19 CEFUROXIME SODIUM B BRAUN Labeling Approval
05/01/2015 AMPICILLIN AND SULBACTAM
ANDA #065176		 SUPPL-10 AMPICILLIN SODIUM; SULBACTAM SODIUM HQ SPECLT PHARMA Labeling Approval
05/01/2015 IBUPROFEN
ANDA #075010		 SUPPL-9 IBUPROFEN LNK Labeling Approval
05/01/2015 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-5 ENALAPRIL MALEATE AIPING PHARM INC Labeling Approval
05/01/2015 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-10 ENALAPRIL MALEATE AIPING PHARM INC Labeling Approval
05/01/2015 ENALAPRIL MALEATE
ANDA #075178		 SUPPL-11 ENALAPRIL MALEATE AIPING PHARM INC Labeling Approval
05/01/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #077128		 SUPPL-10 BENAZEPRIL HYDROCHLORIDE COREPHARMA Labeling Approval
05/01/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #077128		 SUPPL-11 BENAZEPRIL HYDROCHLORIDE COREPHARMA Labeling Approval
05/01/2015 QUETIAPINE FUMARATE
ANDA #077380		 SUPPL-2 QUETIAPINE FUMARATE DR REDDYS LABS LTD Labeling Approval
05/01/2015 QUETIAPINE FUMARATE
ANDA #077380		 SUPPL-3 QUETIAPINE FUMARATE DR REDDYS LABS LTD Labeling Approval
05/01/2015 ALLOPURINOL
ANDA #078253		 SUPPL-5 ALLOPURINOL NORTHSTAR HLTHCARE Labeling Approval
05/01/2015 ALLOPURINOL
ANDA #078253		 SUPPL-6 ALLOPURINOL NORTHSTAR HLTHCARE Labeling Approval
05/01/2015 SUMATRIPTAN SUCCINATE
ANDA #078295		 SUPPL-7 SUMATRIPTAN SUCCINATE SUN PHARM INDS Labeling Approval
05/01/2015 VERAPAMIL HYDROCHLORIDE
ANDA #078306		 SUPPL-6 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
05/01/2015 VERAPAMIL HYDROCHLORIDE
ANDA #078306		 SUPPL-8 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
05/01/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #078554		 SUPPL-5 VENLAFAXINE HYDROCHLORIDE HERITAGE Labeling Approval
05/01/2015 TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135		 SUPPL-4 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
05/01/2015 TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135		 SUPPL-5 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
05/01/2015 TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
ANDA #079135		 SUPPL-6 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
05/01/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090150		 SUPPL-6 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM APOTEX Labeling Approval
05/01/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090150		 SUPPL-7 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM APOTEX Labeling Approval
05/01/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090150		 SUPPL-8 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM APOTEX Labeling Approval
05/01/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090150		 SUPPL-9 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM APOTEX Labeling Approval
05/01/2015 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #090406		 SUPPL-2 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE NORVIUM BIOSCIENCE Labeling Approval
05/01/2015 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #090406		 SUPPL-4 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE NORVIUM BIOSCIENCE Labeling Approval
05/01/2015 FLUMAZENIL
ANDA #090584		 SUPPL-1 FLUMAZENIL SAGENT PHARMS Labeling Approval
05/01/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090686		 SUPPL-4 DONEPEZIL HYDROCHLORIDE TORRENT PHARMS Manufacturing (CMC) Approval
05/01/2015 ELIQUIS
NDA #202155		 SUPPL-8 APIXABAN BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
05/01/2015 TESTOSTERONE
NDA #203098		 SUPPL-1 TESTOSTERONE PERRIGO ISRAEL Manufacturing (CMC) Approval
05/01/2015 FLUDEOXYGLUCOSE F18
ANDA #203710		 ORIG-1 FLUDEOXYGLUCOSE F-18 BIOMEDCL RES FDN Approval
05/01/2015 FLUDEOXYGLUCOSE F18
ANDA #203837		 ORIG-1 FLUDEOXYGLUCOSE F-18 BIOMEDCL RES FDN Approval
05/01/2015 AMMONIA N 13
ANDA #204352		 ORIG-1 AMMONIA N-13 BIOMEDCL RES FDN Approval
05/01/2015 FESOTERODINE FUMARATE
ANDA #204844		 ORIG-1 FESOTERODINE FUMARATE SANDOZ INC Tentative Approval
05/03/2015 FENTANYL CITRATE
ANDA #079075		 SUPPL-2 FENTANYL CITRATE WATSON LABS Labeling Approval
05/03/2015 FENTANYL CITRATE
ANDA #079075		 SUPPL-9 FENTANYL CITRATE WATSON LABS Labeling Approval
05/04/2015 ULTRA-TECHNEKOW FM
NDA #017243		 SUPPL-46 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Labeling Approval
05/04/2015 CUROSURF
BLA #020744		 SUPPL-30 PORACTANT ALFA CHIESI USA INC Approval
05/04/2015 BONIVA
NDA #021858		 SUPPL-18 IBANDRONATE SODIUM ROCHE Manufacturing (CMC) Approval
05/04/2015 MIDAZOLAM HYDROCHLORIDE
ANDA #075856		 SUPPL-9 MIDAZOLAM HYDROCHLORIDE HOSPIRA Labeling Approval
05/04/2015 RIBAVIRIN
ANDA #077094		 SUPPL-20 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
05/04/2015 RIBAVIRIN
ANDA #077094		 SUPPL-21 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
05/04/2015 NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #077381		 SUPPL-6 NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
05/04/2015 NAPROXEN SODIUM
ANDA #078432		 SUPPL-3 NAPROXEN SODIUM AMNEAL PHARMS NY Labeling Approval
05/04/2015 TRANDOLAPRIL
ANDA #078508		 SUPPL-3 TRANDOLAPRIL EPIC PHARMA Labeling Approval
05/04/2015 TRANDOLAPRIL
ANDA #078508		 SUPPL-4 TRANDOLAPRIL EPIC PHARMA Labeling Approval
05/04/2015 OXALIPLATIN
ANDA #078811		 SUPPL-2 OXALIPLATIN FRESENIUS KABI USA Labeling Approval
05/04/2015 OXALIPLATIN
ANDA #078811		 SUPPL-10 OXALIPLATIN FRESENIUS KABI USA Labeling Approval
05/04/2015 PERINDOPRIL ERBUMINE
ANDA #090072		 SUPPL-2 PERINDOPRIL ERBUMINE HIKMA Labeling Approval
05/04/2015 PERINDOPRIL ERBUMINE
ANDA #090072		 SUPPL-4 PERINDOPRIL ERBUMINE HIKMA Labeling Approval
05/04/2015 PERINDOPRIL ERBUMINE
ANDA #090072		 SUPPL-7 PERINDOPRIL ERBUMINE HIKMA Labeling Approval
05/04/2015 GABAPENTIN
ANDA #090158		 SUPPL-2 GABAPENTIN NORVIUM BIOSCIENCE Labeling Approval
05/04/2015 GABAPENTIN
ANDA #090158		 SUPPL-4 GABAPENTIN NORVIUM BIOSCIENCE Labeling Approval
05/04/2015 MONTELUKAST SODIUM
ANDA #091414		 SUPPL-8 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
05/04/2015 MONTELUKAST SODIUM
ANDA #091414		 SUPPL-9 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
05/04/2015 NAPROXEN
ANDA #091432		 SUPPL-2 NAPROXEN NUVO PHARMS INC Labeling Approval
05/04/2015 ALOSETRON HYDROCHLORIDE
ANDA #200652		 ORIG-1 ALOSETRON HYDROCHLORIDE HIKMA Approval
05/04/2015 MONTELUKAST SODIUM
ANDA #200889		 SUPPL-8 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
05/04/2015 MONTELUKAST SODIUM
ANDA #200889		 SUPPL-9 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
05/04/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #202131		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL XIROMED Approval
05/04/2015 MORPHINE SULFATE
ANDA #202348		 SUPPL-1 MORPHINE SULFATE SPECGX LLC Labeling Approval
05/04/2015 QUETIAPINE FUMARATE
ANDA #203150		 SUPPL-1 QUETIAPINE FUMARATE JUBILANT GENERICS Labeling Approval
05/04/2015 NEURACEQ
NDA #204677		 SUPPL-5 FLORBETABEN F-18 LIFE MOLECULAR Manufacturing (CMC) Approval
05/05/2015 XARELTO
NDA #022406		 SUPPL-14 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
05/05/2015 DOCEFREZ
NDA #022534		 SUPPL-6 DOCETAXEL SUN PHARM Manufacturing (CMC) Approval
05/05/2015 DOCETAXEL
NDA #022534		 SUPPL-6 DOCETAXEL SUN PHARM Manufacturing (CMC) Approval
05/05/2015 VPRIV
BLA #022575		 SUPPL-17 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
05/05/2015 VIBRAMYCIN
NDA #050007		 SUPPL-29 DOXYCYCLINE HYCLATE PFIZER Manufacturing (CMC) Approval
05/05/2015 EDURANT
NDA #202022		 SUPPL-9 RILPIVIRINE HYDROCHLORIDE JANSSEN PRODS Labeling Approval
05/05/2015 COMPLERA
NDA #202123		 SUPPL-20 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
05/05/2015 BIMATOPROST
ANDA #202565		 ORIG-1 BIMATOPROST SANDOZ Approval
05/06/2015 EFUDEX
NDA #016831		 SUPPL-57 FLUOROURACIL EXTROVIS Manufacturing (CMC) Approval
05/06/2015 PEPCID AC
NDA #020325		 SUPPL-27 FAMOTIDINE J AND J CONSUMER INC Manufacturing (CMC) Approval
05/06/2015 INTELENCE
NDA #022187		 SUPPL-17 ETRAVIRINE JANSSEN R AND D Manufacturing (CMC) Approval
05/06/2015 GUANFACINE HYDROCHLORIDE
ANDA #074673		 SUPPL-8 GUANFACINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
05/06/2015 GUANFACINE HYDROCHLORIDE
ANDA #074673		 SUPPL-11 GUANFACINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
05/06/2015 PROLEUKIN
BLA #103293		 SUPPL-5139 ALDESLEUKIN CHIRON Approval
05/06/2015 PENNSAID
NDA #204623		 SUPPL-4 DICLOFENAC SODIUM HORIZON Manufacturing (CMC) Approval
05/07/2015 PROVERA
NDA #011839		 SUPPL-79 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
05/07/2015 PROVERA
NDA #011839		 SUPPL-80 MEDROXYPROGESTERONE ACETATE PFIZER Labeling Approval
05/07/2015 COMBIPATCH
NDA #020870		 SUPPL-19 ESTRADIOL; NORETHINDRONE ACETATE NOVEN PHARMS INC Labeling Approval
05/07/2015 HYDRALAZINE HYDROCHLORIDE
ANDA #040730		 SUPPL-2 HYDRALAZINE HYDROCHLORIDE RISING Labeling Approval
05/07/2015 GEMCITABINE HYDROCHLORIDE
ANDA #079160		 SUPPL-2 GEMCITABINE HYDROCHLORIDE ACTAVIS TOTOWA Manufacturing (CMC) Approval
05/07/2015 AVASTIN
BLA #125085		 SUPPL-308 BEVACIZUMAB GENENTECH Approval
05/07/2015 TANZEUM
BLA #125431		 SUPPL-9 ALBIGLUTIDE GLAXOSMITHKLINE LLC Approval
05/07/2015 DOXERCALCIFEROL
ANDA #203929		 ORIG-1 DOXERCALCIFEROL EPIC PHARMA LLC Approval
05/07/2015 VASOSTRICT
NDA #204485		 SUPPL-2 VASOPRESSIN ENDO OPERATIONS Manufacturing (CMC) Approval
05/08/2015 AVELOX
NDA #021085		 SUPPL-60 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Efficacy Approval
05/08/2015 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
NDA #021277		 SUPPL-56 MOXIFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Efficacy Approval
05/08/2015 DOXYCYCLINE
ANDA #065285		 SUPPL-18 DOXYCYCLINE LANNETT CO INC Manufacturing (CMC) Approval
05/08/2015 GEMFIBROZIL
ANDA #075034		 SUPPL-25 GEMFIBROZIL APOTEX Labeling Approval
05/08/2015 GEMFIBROZIL
ANDA #075034		 SUPPL-26 GEMFIBROZIL APOTEX Labeling Approval
05/08/2015 FLUVOXAMINE MALEATE
ANDA #075889		 SUPPL-24 FLUVOXAMINE MALEATE NORVIUM BIOSCIENCE Labeling Approval
05/08/2015 MORPHINE SULFATE
ANDA #076720		 SUPPL-13 MORPHINE SULFATE NESHER PHARMS Labeling Approval
05/08/2015 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #076731		 SUPPL-14 GLYBURIDE; METFORMIN HYDROCHLORIDE IMPAX LABS INC Labeling Approval
05/08/2015 MORPHINE SULFATE
ANDA #076733		 SUPPL-12 MORPHINE SULFATE NESHER PHARMS Labeling Approval
05/08/2015 MORPHINE SULFATE
ANDA #077855		 SUPPL-8 MORPHINE SULFATE NESHER PHARMS Labeling Approval
05/08/2015 LEUPROLIDE ACETATE
ANDA #078885		 SUPPL-12 LEUPROLIDE ACETATE SUN PHARM Labeling Approval
05/08/2015 GABAPENTIN
ANDA #078974		 SUPPL-3 GABAPENTIN MISSION PHARMACAL Labeling Approval
05/08/2015 GABAPENTIN
ANDA #078974		 SUPPL-4 GABAPENTIN MISSION PHARMACAL Labeling Approval
05/08/2015 METHOCARBAMOL
ANDA #085123		 SUPPL-49 METHOCARBAMOL HIKMA INTL PHARMS Labeling Approval
05/08/2015 TROKENDI XR
NDA #201635		 SUPPL-7 TOPIRAMATE SUPERNUS PHARMS Labeling Approval
05/08/2015 GLUCAGON
NDA #201849		 ORIG-1 GLUCAGON HYDROCHLORIDE FRESENIUS KABI USA Type 5 - New Formulation or New Manufacturer Approval
05/08/2015 VORICONAZOLE
ANDA #202361		 SUPPL-2 VORICONAZOLE RISING Labeling Approval
05/08/2015 VORICONAZOLE
ANDA #202361		 SUPPL-3 VORICONAZOLE RISING Labeling Approval
05/08/2015 TEMOZOLOMIDE
ANDA #203691		 ORIG-1 TEMOZOLOMIDE AMNEAL PHARMS Approval
05/11/2015 DELATESTRYL
NDA #009165		 SUPPL-33 TESTOSTERONE ENANTHATE ENDO PHARMS Labeling Approval
05/11/2015 ORAP
NDA #017473		 SUPPL-49 PIMOZIDE TEVA Manufacturing (CMC) Approval
05/11/2015 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BLA #017881		 SUPPL-23 TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT DRAXIMAGE Approval
05/11/2015 LITHOBID
NDA #018027		 SUPPL-58 LITHIUM CARBONATE ANI PHARMS Manufacturing (CMC) Approval
05/11/2015 BUPRENEX
NDA #018401		 SUPPL-20 BUPRENORPHINE HYDROCHLORIDE INDIVIOR Manufacturing (CMC) Approval
05/11/2015 RINGER'S IN PLASTIC CONTAINER
NDA #018495		 SUPPL-24 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/11/2015 MAXZIDE
NDA #019129		 SUPPL-45 HYDROCHLOROTHIAZIDE; TRIAMTERENE AUROBINDO PHARMA USA Manufacturing (CMC) Approval
05/11/2015 MAXZIDE-25
NDA #019129		 SUPPL-45 HYDROCHLOROTHIAZIDE; TRIAMTERENE AUROBINDO PHARMA USA Manufacturing (CMC) Approval
05/11/2015 BETOPTIC
NDA #019270		 SUPPL-35 BETAXOLOL HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
05/11/2015 ATROVENT
NDA #020393		 SUPPL-14 IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
05/11/2015 ANDRODERM
NDA #020489		 SUPPL-33 TESTOSTERONE ABBVIE Labeling Approval
05/11/2015 TOPAMAX
NDA #020505		 SUPPL-56 TOPIRAMATE JANSSEN PHARMS Manufacturing (CMC) Approval
05/11/2015 MIRAPEX
NDA #020667		 SUPPL-31 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
05/11/2015 ANDROGEL
NDA #021015		 SUPPL-40 TESTOSTERONE BESINS HLTHCARE Labeling Approval
05/11/2015 TESTIM
NDA #021454		 SUPPL-23 TESTOSTERONE ENDO OPERATIONS Labeling Approval
05/11/2015 FORTESTA
NDA #021463		 SUPPL-17 TESTOSTERONE ENDO OPERATIONS Labeling Approval
05/11/2015 STRIANT
NDA #021543		 SUPPL-11 TESTOSTERONE AUXILIUM PHARMS LLC Labeling Approval
05/11/2015 VOLTAREN ARTHRITIS PAIN
NDA #022122		 SUPPL-9 DICLOFENAC SODIUM HALEON US HOLDINGS Manufacturing (CMC) Approval
05/11/2015 AVEED
NDA #022219		 SUPPL-5 TESTOSTERONE UNDECANOATE ENDO OPERATIONS Labeling Approval
05/11/2015 ANDROGEL
NDA #022309		 SUPPL-14 TESTOSTERONE BESINS HLTHCARE Labeling Approval
05/11/2015 SPRIX
NDA #022382		 SUPPL-11 KETOROLAC TROMETHAMINE ZYLA Manufacturing (CMC) Approval
05/11/2015 AXIRON
NDA #022504		 SUPPL-12 TESTOSTERONE ELI LILLY AND CO Labeling Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #040530		 SUPPL-10 TESTOSTERONE CYPIONATE PADAGIS US Labeling Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #040615		 SUPPL-5 TESTOSTERONE CYPIONATE SANDOZ Labeling Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #040652		 SUPPL-6 TESTOSTERONE CYPIONATE RISING Labeling Approval
05/11/2015 STROMECTOL
NDA #050742		 SUPPL-28 IVERMECTIN MERCK SHARP DOHME Manufacturing (CMC) Approval
05/11/2015 TRAMADOL HYDROCHLORIDE
ANDA #075968		 SUPPL-9 TRAMADOL HYDROCHLORIDE GRAVITI PHARMS Labeling Approval
05/11/2015 TRAMADOL HYDROCHLORIDE
ANDA #075968		 SUPPL-10 TRAMADOL HYDROCHLORIDE GRAVITI PHARMS Labeling Approval
05/11/2015 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-12 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
05/11/2015 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-13 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
05/11/2015 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-15 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
05/11/2015 TESTOSTERONE PROPIONATE
ANDA #080188		 SUPPL-120 TESTOSTERONE PROPIONATE WATSON LABS Labeling Approval
05/11/2015 METHYLTESTOSTERONE
ANDA #080767		 SUPPL-78 METHYLTESTOSTERONE IMPAX LABS Labeling Approval
05/11/2015 TESTOPEL
ANDA #080911		 SUPPL-19 TESTOSTERONE ENDO OPERATIONS Labeling Approval
05/11/2015 TESTRED
ANDA #083976		 SUPPL-32 METHYLTESTOSTERONE BAUSCH Labeling Approval
05/11/2015 METHYLTESTOSTERONE
ANDA #084310		 SUPPL-78 METHYLTESTOSTERONE IMPAX LABS Labeling Approval
05/11/2015 DEPO-TESTOSTERONE
ANDA #085635		 SUPPL-30 TESTOSTERONE CYPIONATE PFIZER Labeling Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #086029		 SUPPL-87 TESTOSTERONE CYPIONATE WATSON LABS Labeling Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #086030		 SUPPL-48 TESTOSTERONE CYPIONATE WATSON PHARMS INC Labeling Approval
05/11/2015 TESTOSTERONE
ANDA #086417		 SUPPL-25 TESTOSTERONE DR REDDYS Labeling Approval
05/11/2015 ANDROID 10
ANDA #086450		 SUPPL-13 METHYLTESTOSTERONE VALEANT PHARMS NORTH Labeling Approval
05/11/2015 METHYLTESTOSTERONE
ANDA #087092		 SUPPL-4 METHYLTESTOSTERONE LANNETT Labeling Approval
05/11/2015 METHYLTESTOSTERONE
ANDA #087111		 SUPPL-4 METHYLTESTOSTERONE LANNETT Labeling Approval
05/11/2015 ANDROID 25
ANDA #087147		 SUPPL-13 METHYLTESTOSTERONE VALEANT PHARM INTL Labeling Approval
05/11/2015 VIRILON
ANDA #087750		 SUPPL-15 METHYLTESTOSTERONE CHARTWELL Labeling Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #091244		 SUPPL-5 TESTOSTERONE CYPIONATE HIKMA FARMACEUTICA Labeling Approval
05/11/2015 NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #200897		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE XIROMED Approval
05/11/2015 TESTOSTERONE CYPIONATE
ANDA #201720		 SUPPL-5 TESTOSTERONE CYPIONATE SUN PHARM INDS LTD Labeling Approval
05/11/2015 TESTOSTERONE
NDA #202763		 SUPPL-3 TESTOSTERONE ANI PHARMS Labeling Approval
05/11/2015 TESTOSTERONE
NDA #203098		 SUPPL-6 TESTOSTERONE PERRIGO ISRAEL Labeling Approval
05/11/2015 VOGELXO
NDA #204399		 SUPPL-2 TESTOSTERONE UPSHER SMITH LABS Labeling Approval
05/11/2015 VARITHENA
NDA #205098		 SUPPL-9 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
05/11/2015 NATESTO
NDA #205488		 SUPPL-1 TESTOSTERONE ACERUS Labeling Approval
05/11/2015 CERDELGA
NDA #205494		 SUPPL-2 ELIGLUSTAT TARTRATE GENZYME CORP Manufacturing (CMC) Approval
05/11/2015 EVZIO
NDA #205787		 SUPPL-2 NALOXONE HYDROCHLORIDE KALEO INC Manufacturing (CMC) Approval
05/12/2015 OPCON-A
NDA #020065		 SUPPL-20 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE BAUSCH AND LOMB Manufacturing (CMC) Approval
05/12/2015 PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
ANDA #040902		 SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
05/12/2015 TRAZODONE HYDROCHLORIDE
ANDA #072192		 SUPPL-41 TRAZODONE HYDROCHLORIDE OXFORD PHARMS Manufacturing (CMC) Approval
05/12/2015 TRAZODONE HYDROCHLORIDE
ANDA #072193		 SUPPL-41 TRAZODONE HYDROCHLORIDE OXFORD PHARMS Manufacturing (CMC) Approval
05/12/2015 TYSABRI
BLA #125104		 SUPPL-950 NATALIZUMAB BIOGEN IDEC Approval
05/12/2015 MORPHINE SULFATE
ANDA #203518		 ORIG-1 MORPHINE SULFATE TRIS PHARMA INC Approval
05/12/2015 XOFIGO
NDA #203971		 SUPPL-5 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
05/13/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016677		 SUPPL-150 SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/13/2015 ALOPRIM
NDA #020298		 SUPPL-6 ALLOPURINOL SODIUM MYLAN Manufacturing (CMC) Approval
05/13/2015 VENOFER
NDA #021135		 SUPPL-28 FERRIC OXYHYDROXIDE AM REGENT Manufacturing (CMC) Approval
05/13/2015 LAMIVUDINE AND ZIDOVUDINE
ANDA #079128		 ORIG-1 LAMIVUDINE; ZIDOVUDINE STRIDES PHARMA Approval
05/13/2015 PEGINTRON
BLA #103949		 SUPPL-5298 PEGINTERFERON ALFA-2B SCHERING Approval
05/13/2015 SYLATRON
BLA #103949		 SUPPL-5298 PEGINTERFERON ALFA-2B SCHERING Approval
05/13/2015 STENDRA
NDA #202276		 SUPPL-10 AVANAFIL METUCHEN PHARMS Labeling Approval
05/13/2015 AKYNZEO
NDA #205718		 SUPPL-4 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Labeling Approval
05/14/2015 ISOVUE-128
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 ISOVUE-200
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 ISOVUE-250
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 ISOVUE-300
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 ISOVUE-370
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 ISOVUE-M 200
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 ISOVUE-M 300
NDA #018735		 SUPPL-55 IOPAMIDOL BRACCO Manufacturing (CMC) Approval
05/14/2015 FAMVIR
NDA #020363		 SUPPL-44 FAMCICLOVIR NOVARTIS Manufacturing (CMC) Approval
05/14/2015 TREXIMET
NDA #021926		 SUPPL-11 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE CURRAX Labeling Approval
05/14/2015 TREXIMET
NDA #021926		 SUPPL-12 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE CURRAX Efficacy Approval
05/14/2015 HYCOFENIX
NDA #022279		 ORIG-1 GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE CHARTWELL RX Type 4 - New Combination Approval
05/14/2015 FLOWTUSS
NDA #022424		 ORIG-1 GUAIFENESIN; HYDROCODONE BITARTRATE CHARTWELL RX Type 4 - New Combination Approval
05/14/2015 GILENYA
NDA #022527		 SUPPL-15 FINGOLIMOD HYDROCHLORIDE NOVARTIS REMS Approval
05/14/2015 TRIAMCINOLONE ACETONIDE
ANDA #040467		 SUPPL-5 TRIAMCINOLONE ACETONIDE FOUGERA PHARMS Labeling Approval
05/14/2015 BACTROBAN
NDA #050703		 SUPPL-16 MUPIROCIN CALCIUM GLAXOSMITHKLINE Labeling Approval
05/14/2015 AZITHROMYCIN
ANDA #065209		 SUPPL-21 AZITHROMYCIN SANDOZ Labeling Approval
05/14/2015 AZITHROMYCIN
ANDA #065211		 SUPPL-25 AZITHROMYCIN SANDOZ Labeling Approval
05/14/2015 AZITHROMYCIN
ANDA #065212		 SUPPL-23 AZITHROMYCIN SANDOZ Labeling Approval
05/14/2015 DICLOFENAC POTASSIUM
ANDA #075463		 SUPPL-12 DICLOFENAC POTASSIUM RK PHARMA Labeling Approval
05/14/2015 IFOSFAMIDE
ANDA #076657		 SUPPL-17 IFOSFAMIDE MEITHEAL Labeling Approval
05/14/2015 IFOSFAMIDE
ANDA #076657		 SUPPL-21 IFOSFAMIDE MEITHEAL Labeling Approval
05/14/2015 IFOSFAMIDE
ANDA #076657		 SUPPL-25 IFOSFAMIDE MEITHEAL Labeling Approval
05/14/2015 ESCITALOPRAM OXALATE
ANDA #077550		 ORIG-1 ESCITALOPRAM OXALATE ESJAY PHARMA Approval
05/14/2015 GEMFIBROZIL
ANDA #078012		 SUPPL-7 GEMFIBROZIL EPIC PHARMA LLC Labeling Approval
05/14/2015 GEMFIBROZIL
ANDA #078012		 SUPPL-8 GEMFIBROZIL EPIC PHARMA LLC Labeling Approval
05/14/2015 DUTASTERIDE
ANDA #090095		 SUPPL-2 DUTASTERIDE BARR Labeling Approval
05/14/2015 NALTREXONE HYDROCHLORIDE
ANDA #091205		 SUPPL-3 NALTREXONE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
05/14/2015 NORETHINDRONE
ANDA #091209		 SUPPL-5 NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
05/14/2015 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-1 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/14/2015 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-3 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/14/2015 BUPROPION HYDROCHLORIDE
ANDA #201331		 SUPPL-2 BUPROPION HYDROCHLORIDE WOCKHARDT LTD Labeling Approval
05/14/2015 PARICALCITOL
NDA #201657		 SUPPL-2 PARICALCITOL HOSPIRA Manufacturing (CMC) Approval
05/14/2015 ESCITALOPRAM OXALATE
ANDA #202227		 SUPPL-3 ESCITALOPRAM OXALATE AMNEAL PHARMS Labeling Approval
05/14/2015 MAGNESIUM SULFATE
ANDA #202411		 ORIG-1 MAGNESIUM SULFATE HOSPIRA Approval
05/14/2015 SIRTURO
NDA #204384		 SUPPL-5 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
05/14/2015 LAMIVUDINE; ZIDOVUDINE
NDA #204914		 SUPPL-1 LAMIVUDINE; ZIDOVUDINE MYLAN LABS Manufacturing (CMC) Approval
05/15/2015 CEFTAZIDIME IN DEXTROSE CONTAINER
NDA #050823		 SUPPL-4 CEFTAZIDIME B BRAUN Labeling Approval
05/15/2015 AZITHROMYCIN
ANDA #065398		 ORIG-1 AZITHROMYCIN LUPIN LTD Approval
05/15/2015 AZITHROMYCIN
ANDA #065399		 ORIG-1 AZITHROMYCIN LUPIN LTD Approval
05/15/2015 AZITHROMYCIN
ANDA #065400		 ORIG-1 AZITHROMYCIN LUPIN LTD Approval
05/15/2015 AZITHROMYCIN
ANDA #065488		 ORIG-1 AZITHROMYCIN CHARTWELL RX Approval
05/15/2015 XIAFLEX
BLA #125338		 SUPPL-85 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
05/15/2015 XIAFLEX
BLA #125338		 SUPPL-87 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
05/15/2015 XIAFLEX
BLA #125338		 SUPPL-88 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
05/15/2015 CLONIDINE HYDROCHLORIDE
ANDA #202792		 ORIG-1 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
05/15/2015 CLONIDINE HYDROCHLORIDE
ANDA #203320		 ORIG-1 CLONIDINE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
05/15/2015 DESVENLAFAXINE
NDA #204150		 SUPPL-3 DESVENLAFAXINE ALEMBIC PHARMS LTD Labeling Approval
05/16/2015 BUPROPION HYDROCHLORIDE
ANDA #075584		 SUPPL-41 BUPROPION HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
05/16/2015 BUPROPION HYDROCHLORIDE
ANDA #075584		 SUPPL-42 BUPROPION HYDROCHLORIDE APNAR PHARMA LP Labeling Approval
05/16/2015 MORPHINE SULFATE
ANDA #076412		 SUPPL-19 MORPHINE SULFATE SPECGX LLC Labeling Approval
05/16/2015 MORPHINE SULFATE
ANDA #076438		 SUPPL-16 MORPHINE SULFATE SPECGX LLC Labeling Approval
05/16/2015 ALYACEN 1/35
ANDA #091634		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
05/16/2015 ALYACEN 7/7/7
ANDA #091636		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
05/16/2015 ALYACEN 777
ANDA #091636		 SUPPL-3 NORETHINDRONE; ETHINYL ESTRADIOL GLENMARK PHARMS LTD Labeling Approval
05/18/2015 ADVIL
NDA #018989		 SUPPL-83 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
05/18/2015 LAMICTAL
NDA #020241		 SUPPL-53 LAMOTRIGINE GLAXOSMITHKLINE LLC Efficacy Approval
05/18/2015 LOTREL
NDA #020364		 SUPPL-61 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ Labeling Approval
05/18/2015 LAMICTAL CD
NDA #020764		 SUPPL-46 LAMOTRIGINE GLAXOSMITHKLINE LLC Efficacy Approval
05/18/2015 SANDOSTATIN LAR
NDA #021008		 SUPPL-33 OCTREOTIDE ACETATE NOVARTIS Manufacturing (CMC) Approval
05/18/2015 IPRIVASK
BLA #021271		 SUPPL-7 DESIRUDIN RECOMBINANT BAUSCH Approval
05/18/2015 ALTOPREV
NDA #021316		 SUPPL-32 LOVASTATIN COVIS Manufacturing (CMC) Approval
05/18/2015 NICORETTE
NDA #021330		 SUPPL-18 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
05/18/2015 FORTAMET
NDA #021574		 SUPPL-18 METFORMIN HYDROCHLORIDE ANDRX LABS LLC Manufacturing (CMC) Approval
05/18/2015 LAMICTAL ODT
NDA #022251		 SUPPL-17 LAMOTRIGINE GLAXOSMITHKLINE LLC Efficacy Approval
05/18/2015 NAMENDA XR
NDA #022525		 SUPPL-10 MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
05/18/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #070175		 SUPPL-50 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
05/18/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #070176		 SUPPL-50 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
05/18/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #070177		 SUPPL-49 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
05/18/2015 PROPRANOLOL HYDROCHLORIDE
ANDA #070178		 SUPPL-52 PROPRANOLOL HYDROCHLORIDE WATSON LABS Labeling Approval
05/18/2015 CLONIDINE
ANDA #076157		 SUPPL-1 CLONIDINE DIFGEN PHARMS Labeling Approval
05/18/2015 CLONIDINE
ANDA #076157		 SUPPL-5 CLONIDINE DIFGEN PHARMS Labeling Approval
05/18/2015 CLONIDINE
ANDA #076166		 SUPPL-5 CLONIDINE MYLAN TECHNOLOGIES Labeling Approval
05/18/2015 CLONAZEPAM
ANDA #077147		 SUPPL-4 CLONAZEPAM ACCORD HLTHCARE Labeling Approval
05/18/2015 ADENOSINE
ANDA #077425		 SUPPL-2 ADENOSINE MEITHEAL Labeling Approval
05/18/2015 ADENOSINE
ANDA #077425		 SUPPL-4 ADENOSINE MEITHEAL Labeling Approval
05/18/2015 GEMCITABINE HYDROCHLORIDE
ANDA #077983		 SUPPL-3 GEMCITABINE HYDROCHLORIDE TEVA PHARMS Labeling Approval
05/18/2015 GEMCITABINE HYDROCHLORIDE
ANDA #077983		 SUPPL-12 GEMCITABINE HYDROCHLORIDE TEVA PHARMS Labeling Approval
05/18/2015 LINEZOLID
ANDA #078061		 ORIG-1 LINEZOLID TEVA PHARMS USA Approval
05/18/2015 LEVETIRACETAM
ANDA #078582		 SUPPL-10 LEVETIRACETAM STRIDES PHARMA Labeling Approval
05/18/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078946		 SUPPL-3 HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Labeling Approval
05/18/2015 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078946		 SUPPL-4 HYDROCHLOROTHIAZIDE; VALSARTAN LUPIN LTD Labeling Approval
05/18/2015 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #090979		 SUPPL-3 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE PADAGIS ISRAEL Labeling Approval
05/18/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-12 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
05/18/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #091629		 SUPPL-13 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM AUROBINDO PHARMA Labeling Approval
05/18/2015 FAMCICLOVIR
ANDA #201333		 SUPPL-1 FAMCICLOVIR NATCO PHARMA Labeling Approval
05/18/2015 ILUVIEN
NDA #201923		 SUPPL-1 FLUOCINOLONE ACETONIDE ALIMERA SCIENCES INC Manufacturing (CMC) Approval
05/18/2015 RISEDRONATE SODIUM
ANDA #203217		 ORIG-1 RISEDRONATE SODIUM TEVA PHARMS USA Approval
05/18/2015 GATTEX KIT
NDA #203441		 SUPPL-5 TEDUGLUTIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
05/18/2015 NEURACEQ
NDA #204677		 SUPPL-7 FLORBETABEN F-18 LIFE MOLECULAR Manufacturing (CMC) Approval
05/18/2015 TAPENTADOL
ANDA #204971		 ORIG-1 TAPENTADOL ACTAVIS ELIZABETH Tentative Approval
05/18/2015 HEMANGEOL
NDA #205410		 SUPPL-1 PROPRANOLOL HYDROCHLORIDE PIERRE FABRE Manufacturing (CMC) Approval
05/18/2015 AURYXIA
NDA #205874		 SUPPL-2 FERRIC CITRATE KERYX BIOPHARMS Manufacturing (CMC) Approval
05/18/2015 INVEGA HAFYERA
NDA #207946		 ORIG-1 PALIPERIDONE PALMITATE JANSSEN PHARMS Type 5 - New Formulation or New Manufacturer Approval
05/18/2015 INVEGA TRINZA
NDA #207946		 ORIG-1 PALIPERIDONE PALMITATE JANSSEN PHARMS Type 5 - New Formulation or New Manufacturer Approval
05/19/2015 SORIATANE
NDA #019821		 SUPPL-27 ACITRETIN STIEFEL LABS INC Labeling Approval
05/19/2015 PROGRAF
NDA #050708		 SUPPL-45 TACROLIMUS ASTELLAS Labeling Approval
05/19/2015 PROGRAF
NDA #050709		 SUPPL-38 TACROLIMUS ASTELLAS Labeling Approval
05/19/2015 AZATHIOPRINE
ANDA #074069		 SUPPL-10 AZATHIOPRINE AMNEAL Labeling Approval
05/19/2015 AMIODARONE HYDROCHLORIDE
ANDA #077069		 SUPPL-5 AMIODARONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/19/2015 AMIODARONE HYDROCHLORIDE
ANDA #077069		 SUPPL-7 AMIODARONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/19/2015 AMIODARONE HYDROCHLORIDE
ANDA #077069		 SUPPL-8 AMIODARONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
05/19/2015 SPIRONOLACTONE
ANDA #086809		 SUPPL-69 SPIRONOLACTONE CHARTWELL RX Labeling Approval
05/19/2015 DEXRAZOXANE HYDROCHLORIDE
ANDA #200752		 SUPPL-2 DEXRAZOXANE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
05/19/2015 DEXRAZOXANE HYDROCHLORIDE
ANDA #200752		 SUPPL-4 DEXRAZOXANE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
05/19/2015 GLIPIZIDE
ANDA #202298		 ORIG-1 GLIPIZIDE NORVIUM BIOSCIENCE Approval
05/19/2015 NEURACEQ
NDA #204677		 SUPPL-6 FLORBETABEN F-18 LIFE MOLECULAR Manufacturing (CMC) Approval
05/19/2015 TAPENTADOL
ANDA #205057		 ORIG-1 TAPENTADOL ROXANE Tentative Approval
05/20/2015 PFIZERPEN
ANDA #060657		 SUPPL-19 PENICILLIN G POTASSIUM PFIZER Labeling Approval
05/20/2015 ADENOSINE
ANDA #078076		 SUPPL-3 ADENOSINE RISING Labeling Approval
05/20/2015 PERINDOPRIL ERBUMINE
ANDA #079070		 SUPPL-4 PERINDOPRIL ERBUMINE AUROBINDO PHARMA Labeling Approval
05/20/2015 PERINDOPRIL ERBUMINE
ANDA #079070		 SUPPL-6 PERINDOPRIL ERBUMINE AUROBINDO PHARMA Labeling Approval
05/20/2015 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #202085		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL XIROMED Approval
05/20/2015 ZYTIGA
NDA #202379		 SUPPL-18 ABIRATERONE ACETATE JANSSEN BIOTECH Labeling Approval
05/20/2015 ICLUSIG
NDA #203469		 SUPPL-15 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
05/20/2015 ZERBAXA
NDA #206829		 SUPPL-1 CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM CUBIST PHARMS LLC Labeling Approval
05/21/2015 CATAPRES
NDA #017407		 SUPPL-38 CLONIDINE HYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
05/21/2015 CARDENE
NDA #019734		 SUPPL-25 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/21/2015 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-25 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/21/2015 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-25 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/21/2015 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-25 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/21/2015 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-25 NICARDIPINE HYDROCHLORIDE CHIESI Manufacturing (CMC) Approval
05/21/2015 REBETOL
NDA #020903		 SUPPL-53 RIBAVIRIN MERCK SHARP DOHME Labeling Approval
05/21/2015 ZYMAR
NDA #021493		 SUPPL-10 GATIFLOXACIN ALLERGAN Labeling Approval
05/21/2015 REBETOL
NDA #021546		 SUPPL-9 RIBAVIRIN SCHERING Labeling Approval
05/21/2015 CLOBEX
NDA #021835		 SUPPL-9 CLOBETASOL PROPIONATE GALDERMA LABS LP Manufacturing (CMC) Approval
05/21/2015 FLONASE SENSIMIST ALLERGY RELIEF
NDA #022051		 SUPPL-11 FLUTICASONE FUROATE HALEON US HOLDINGS Labeling Approval
05/21/2015 SAVELLA
NDA #022256		 SUPPL-18 MILNACIPRAN HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
05/21/2015 QUTENZA
NDA #022395		 SUPPL-15 CAPSAICIN AVERITAS Manufacturing (CMC) Approval
05/21/2015 SERTRALINE HYDROCHLORIDE
ANDA #076465		 SUPPL-18 SERTRALINE HYDROCHLORIDE HERITAGE PHARMA AVET Manufacturing (CMC) Approval
05/21/2015 ZOLPIDEM TARTRATE
ANDA #078055		 SUPPL-5 ZOLPIDEM TARTRATE SUN PHARM INDS LTD Labeling Approval
05/21/2015 OMEPRAZOLE
ANDA #091672		 SUPPL-4 OMEPRAZOLE GLENMARK PHARMS LTD Labeling Approval
05/21/2015 INTRON A
BLA #103132		 SUPPL-5191 INTERFERON ALFA-2B SCHERING Approval
05/21/2015 PEGINTRON
BLA #103949		 SUPPL-5297 PEGINTERFERON ALFA-2B SCHERING Approval
05/21/2015 SYLATRON
BLA #103949		 SUPPL-5297 PEGINTERFERON ALFA-2B SCHERING Approval
05/21/2015 PROLIA
BLA #125320		 SUPPL-162 DENOSUMAB AMGEN Approval
05/21/2015 XGEVA
BLA #125320		 SUPPL-162 DENOSUMAB AMGEN Approval
05/21/2015 BICALUTAMIDE
ANDA #200274		 ORIG-1 BICALUTAMIDE APOTEX Approval
05/21/2015 VIENVA
ANDA #201088		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Approval
05/21/2015 METHOTREXATE SODIUM
ANDA #201749		 ORIG-1 METHOTREXATE SODIUM SUN PHARM Approval
05/21/2015 RASAGILINE MESYLATE
ANDA #201899		 ORIG-1 RASAGILINE MESYLATE ALKEM LABS LTD Tentative Approval
05/21/2015 FELODIPINE
ANDA #203032		 ORIG-1 FELODIPINE ORBION PHARMS Approval
05/21/2015 ERIVEDGE
NDA #203388		 SUPPL-5 VISMODEGIB GENENTECH Labeling Approval
05/21/2015 ERIVEDGE
NDA #203388		 SUPPL-6 VISMODEGIB GENENTECH Labeling Approval
05/21/2015 ERIVEDGE
NDA #203388		 SUPPL-7 VISMODEGIB GENENTECH Labeling Approval
05/21/2015 ERIVEDGE
NDA #203388		 SUPPL-8 VISMODEGIB GENENTECH Labeling Approval
05/21/2015 LEVETIRACETAM
ANDA #203468		 ORIG-1 LEVETIRACETAM PRINSTON INC Approval
05/21/2015 OMIDRIA
NDA #205388		 SUPPL-1 KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE RAYNER SURGICAL Manufacturing (CMC) Approval
05/21/2015 LOPINAVIR AND RITONAVIR
NDA #205425		 ORIG-1 LOPINAVIR;RITONAVIR CIPLA LTD Type 5 - New Formulation or New Manufacturer Tentative Approval
05/21/2015 MORPHINE SULFATE
ANDA #205758		 ORIG-1 MORPHINE SULFATE HIKMA Approval
05/21/2015 STIOLTO RESPIMAT
NDA #206756		 ORIG-1 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Type 4 - New Combination Approval
05/22/2015 MICRONASE
NDA #017498		 SUPPL-32 GLYBURIDE PFIZER Labeling Approval
05/22/2015 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-119 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
05/22/2015 GLYNASE
NDA #020051		 SUPPL-21 GLYBURIDE PFIZER Labeling Approval
05/22/2015 GALZIN
NDA #020458		 SUPPL-6 ZINC ACETATE TEVA Manufacturing (CMC) Approval
05/22/2015 DIOVAN HCT
NDA #020818		 SUPPL-65 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Manufacturing (CMC) Approval
05/22/2015 EXFORGE
NDA #021990		 SUPPL-25 AMLODIPINE BESYLATE; VALSARTAN NOVARTIS Manufacturing (CMC) Approval
05/22/2015 AFINITOR
NDA #022334		 SUPPL-30 EVEROLIMUS NOVARTIS Efficacy Approval
05/22/2015 CLINDAMYCIN PHOSPHATE
ANDA #065513		 SUPPL-4 CLINDAMYCIN PHOSPHATE EPIC PHARMA LLC Labeling Approval
05/22/2015 BUPROPION HYDROCHLORIDE
ANDA #075491		 SUPPL-30 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
05/22/2015 BUPROPION HYDROCHLORIDE
ANDA #075491		 SUPPL-31 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
05/22/2015 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-7 DIVALPROEX SODIUM APOTEX Labeling Approval
05/22/2015 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-8 DIVALPROEX SODIUM APOTEX Labeling Approval
05/22/2015 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-9 DIVALPROEX SODIUM APOTEX Labeling Approval
05/22/2015 DIVALPROEX SODIUM
ANDA #077615		 SUPPL-10 DIVALPROEX SODIUM APOTEX Labeling Approval
05/22/2015 ELITEK
BLA #103946		 SUPPL-5095 RASBURICASE SANOFI SYNTHELABO Approval
05/22/2015 URSODIOL
ANDA #200826		 SUPPL-5 URSODIOL IMPAX LABS INC Labeling Approval
05/22/2015 DUOPA
NDA #203952		 SUPPL-1 CARBIDOPA; LEVODOPA ABBVIE Manufacturing (CMC) Approval
05/22/2015 MONTELUKAST SODIUM
ANDA #204093		 ORIG-1 MONTELUKAST SODIUM HETERO LABS LTD V Approval
05/22/2015 ACITRETIN
ANDA #204633		 ORIG-1 ACITRETIN SIGMAPHARM LABS LLC Approval
05/22/2015 AURYXIA
NDA #205874		 SUPPL-3 FERRIC CITRATE KERYX BIOPHARMS Manufacturing (CMC) Approval
05/26/2015 HALDOL
NDA #015923		 SUPPL-91 HALOPERIDOL LACTATE JANSSEN PHARMS Labeling Approval
05/26/2015 CIS-MDP
NDA #018124		 SUPPL-24 TECHNETIUM TC-99M MEDRONATE KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
05/26/2015 NUTROPIN AQ
BLA #020522		 SUPPL-54 SOMATROPIN GENENTECH Approval
05/26/2015 NUTROPIN AQ NUSPIN
BLA #020522		 SUPPL-54 SOMATROPIN GENENTECH Approval
05/26/2015 NUTROPIN AQ PEN
BLA #020522		 SUPPL-54 SOMATROPIN GENENTECH Approval
05/26/2015 STRATTERA
NDA #021411		 SUPPL-46 ATOMOXETINE HYDROCHLORIDE LILLY Labeling Approval
05/26/2015 POTIGA
NDA #022345		 SUPPL-10 EZOGABINE GLAXOSMITHKLINE Labeling Approval
05/26/2015 IFOSFAMIDE/MESNA KIT
ANDA #075874		 SUPPL-30 IFOSFAMIDE; MESNA TEVA PHARMS USA Labeling Approval
05/26/2015 IFOSFAMIDE/MESNA KIT
ANDA #075874		 SUPPL-33 IFOSFAMIDE; MESNA TEVA PHARMS USA Labeling Approval
05/26/2015 IFOSFAMIDE/MESNA KIT
ANDA #075874		 SUPPL-37 IFOSFAMIDE; MESNA TEVA PHARMS USA Labeling Approval
05/26/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-23 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
05/26/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-24 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
05/26/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-25 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
05/26/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076265		 SUPPL-26 HYDROCHLOROTHIAZIDE; LISINOPRIL HIKMA INTL PHARMS Labeling Approval
05/26/2015 BISOPROLOL FUMARATE
ANDA #078635		 SUPPL-1 BISOPROLOL FUMARATE UNICHEM Labeling Approval
05/26/2015 BUPROPION HYDROCHLORIDE
ANDA #202304		 ORIG-1 BUPROPION HYDROCHLORIDE PRINSTON INC Approval
05/26/2015 ESCITALOPRAM OXALATE
ANDA #203967		 ORIG-1 ESCITALOPRAM OXALATE ANTRIM PHARMS LLC Approval
05/26/2015 HUMALOG KWIKPEN
BLA #205747		 ORIG-1 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
05/27/2015 ASACOL
NDA #019651		 SUPPL-25 MESALAMINE APIL Efficacy Approval
05/27/2015 NIASPAN
NDA #020381		 SUPPL-50 NIACIN ABBVIE Manufacturing (CMC) Approval
05/27/2015 NIASPAN TITRATION STARTER PACK
NDA #020381		 SUPPL-50 NIACIN ABBVIE Manufacturing (CMC) Approval
05/27/2015 XIFAXAN
NDA #021361		 SUPPL-12 RIFAXIMIN SALIX PHARMS Efficacy Approval
05/27/2015 PREZISTA
NDA #021976		 SUPPL-36 DARUNAVIR JANSSEN PRODS Labeling Approval
05/27/2015 DYLOJECT
NDA #022396		 SUPPL-2 DICLOFENAC SODIUM JAVELIN PHARMS INC Manufacturing (CMC) Approval
05/27/2015 EXPAREL
NDA #022496		 SUPPL-12 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
05/27/2015 MAXITROL
NDA #050023		 SUPPL-31 DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE HARROW EYE Manufacturing (CMC) Approval
05/27/2015 CARBIDOPA AND LEVODOPA
ANDA #075091		 SUPPL-26 CARBIDOPA; LEVODOPA MYLAN Labeling Approval
05/27/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #076759		 SUPPL-14 ONDANSETRON HYDROCHLORIDE TEVA Labeling Approval
05/27/2015 REVONTO
ANDA #078378		 SUPPL-9 DANTROLENE SODIUM USWM Labeling Approval
05/27/2015 ATENOLOL
ANDA #078512		 SUPPL-7 ATENOLOL AUROBINDO PHARMA Labeling Approval
05/27/2015 GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #091071		 ORIG-1 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE ACTAVIS LABS FL Approval
05/27/2015 PARICALCITOL
ANDA #091412		 SUPPL-1 PARICALCITOL DR REDDYS Labeling Approval
05/27/2015 TIGECYCLINE
ANDA #091620		 ORIG-1 TIGECYCLINE SANDOZ Approval
05/27/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #200492		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED Approval
05/27/2015 PREZISTA
NDA #202895		 SUPPL-13 DARUNAVIR JANSSEN PRODS Labeling Approval
05/27/2015 ZOLEDRONIC ACID
ANDA #202930		 SUPPL-4 ZOLEDRONIC ACID GLAND PHARMA LTD Labeling Approval
05/27/2015 VIBERZI
NDA #206940		 ORIG-1 ELUXADOLINE ABBVIE Type 1 - New Molecular Entity Approval
05/28/2015 RAPAMUNE
NDA #021083		 SUPPL-55 SIROLIMUS PF PRISM CV Efficacy Approval
05/28/2015 RAPAMUNE
NDA #021110		 SUPPL-73 SIROLIMUS PF PRISM CV Efficacy Approval
05/28/2015 CLARITHROMYCIN
ANDA #065283		 SUPPL-12 CLARITHROMYCIN SANDOZ Labeling Approval
05/28/2015 CLARITHROMYCIN
ANDA #065283		 SUPPL-13 CLARITHROMYCIN SANDOZ Labeling Approval
05/28/2015 CLARITHROMYCIN
ANDA #065283		 SUPPL-14 CLARITHROMYCIN SANDOZ Labeling Approval
05/28/2015 SULINDAC
ANDA #072710		 SUPPL-9 SULINDAC EPIC PHARMA Labeling Approval
05/28/2015 SULINDAC
ANDA #072711		 SUPPL-9 SULINDAC EPIC PHARMA Labeling Approval
05/28/2015 DESMOPRESSIN ACETATE
ANDA #201831		 ORIG-1 DESMOPRESSIN ACETATE GLENMARK PHARMS LTD Approval
05/28/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #202036		 ORIG-1 VENLAFAXINE HYDROCHLORIDE YAOPHARMA CO LTD Approval
05/28/2015 MOXIFLOXACIN HYDROCHLORIDE
ANDA #204079		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE LUPIN LTD Approval
05/28/2015 VAZCULEP
NDA #204300		 SUPPL-5 PHENYLEPHRINE HYDROCHLORIDE EXELA PHARMA Labeling Approval
05/28/2015 DOXYCYCLINE
ANDA #204446		 ORIG-1 DOXYCYCLINE COSETTE Approval
05/29/2015 KINEVAC
NDA #017697		 SUPPL-25 SINCALIDE BRACCO Manufacturing (CMC) Approval
05/29/2015 CARNITOR
NDA #018948		 SUPPL-26 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
05/29/2015 CARNITOR
NDA #019257		 SUPPL-12 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
05/29/2015 CARNITOR SF
NDA #019257		 SUPPL-12 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
05/29/2015 OXSORALEN-ULTRA
NDA #019600		 SUPPL-17 METHOXSALEN BAUSCH Manufacturing (CMC) Approval
05/29/2015 DIFLUCAN
NDA #019949		 SUPPL-61 FLUCONAZOLE PFIZER Manufacturing (CMC) Approval
05/29/2015 FOSCAVIR
NDA #020068		 SUPPL-21 FOSCARNET SODIUM CLINIGEN HLTHCARE Manufacturing (CMC) Approval
05/29/2015 CARNITOR
NDA #020182		 SUPPL-13 LEVOCARNITINE LEADIANT BIOSCI INC Labeling Approval
05/29/2015 ANGIOMAX
NDA #020873		 SUPPL-32 BIVALIRUDIN SANDOZ Manufacturing (CMC) Approval
05/29/2015 VIREAD
NDA #021356		 SUPPL-49 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
05/29/2015 VIREAD
NDA #022577		 SUPPL-7 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
05/29/2015 METHADONE HYDROCHLORIDE
ANDA #040241		 SUPPL-13 METHADONE HYDROCHLORIDE VISTAPHARM LLC Labeling Approval
05/29/2015 AMIKACIN SULFATE
ANDA #064045		 SUPPL-25 AMIKACIN SULFATE MEITHEAL Labeling Approval
05/29/2015 NALOXONE HYDROCHLORIDE
ANDA #070639		 SUPPL-16 NALOXONE HYDROCHLORIDE INTL MEDICATION Manufacturing (CMC) Approval
05/29/2015 DOXEPIN HYDROCHLORIDE
ANDA #070791		 SUPPL-28 DOXEPIN HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
05/29/2015 AZATHIOPRINE
ANDA #075568		 SUPPL-18 AZATHIOPRINE RISING Labeling Approval
05/29/2015 ECONAZOLE NITRATE
ANDA #076075		 SUPPL-11 ECONAZOLE NITRATE CHARTWELL RX Labeling Approval
05/29/2015 CLONIDINE
ANDA #079090		 SUPPL-7 CLONIDINE DR REDDYS LABS SA Labeling Approval
05/29/2015 MEPERIDINE HYDROCHLORIDE
ANDA #088639		 SUPPL-32 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
05/29/2015 MEPERIDINE HYDROCHLORIDE
ANDA #088639		 SUPPL-33 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
05/29/2015 MEPERIDINE HYDROCHLORIDE
ANDA #088639		 SUPPL-34 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
05/29/2015 MEPERIDINE HYDROCHLORIDE
ANDA #088640		 SUPPL-36 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
05/29/2015 MEPERIDINE HYDROCHLORIDE
ANDA #088640		 SUPPL-37 MEPERIDINE HYDROCHLORIDE BARR Labeling Approval
05/29/2015 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #090081		 SUPPL-5 DROSPIRENONE; ETHINYL ESTRADIOL DR REDDYS LABS SA Labeling Approval
05/29/2015 IMIPENEM AND CILASTATIN
ANDA #090577		 SUPPL-3 CILASTATIN SODIUM; IMIPENEM ACS DOBFAR Labeling Approval
05/29/2015 IMIPENEM AND CILASTATIN
ANDA #090577		 SUPPL-6 CILASTATIN SODIUM; IMIPENEM ACS DOBFAR Labeling Approval
05/29/2015 PERJETA
BLA #125409		 SUPPL-105 PERTUZUMAB GENENTECH Approval
05/29/2015 KADCYLA
BLA #125427		 SUPPL-87 ADO-TRASTUZUMAB EMTANSINE GENENTECH Approval
05/29/2015 LEVONORGESTREL
ANDA #202380		 ORIG-1 LEVONORGESTREL NAARI PTE LTD Approval
05/29/2015 CHLOROTHIAZIDE SODIUM
ANDA #202462		 ORIG-1 CHLOROTHIAZIDE SODIUM SAGENT PHARMS INC Approval
05/29/2015 URSODIOL
ANDA #202540		 SUPPL-1 URSODIOL ENDO OPERATIONS Labeling Approval
05/29/2015 CLINDAMYCIN PHOSPHATE
ANDA #203343		 ORIG-1 CLINDAMYCIN PHOSPHATE ENDO OPERATIONS Approval
05/29/2015 DIVALPROEX SODIUM
ANDA #203730		 ORIG-1 DIVALPROEX SODIUM AMNEAL PHARMS Approval
05/29/2015 METRONIDAZOLE
ANDA #203974		 ORIG-1 METRONIDAZOLE AUROBINDO PHARMA LTD Approval
05/29/2015 ESTRADIOL
ANDA #205256		 ORIG-1 ESTRADIOL AMNEAL PHARMS Approval
05/29/2015 COLISTIMETHATE SODIUM
ANDA #205356		 ORIG-1 COLISTIMETHATE SODIUM XELLIA PHARMS APS Approval
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