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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 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 April 29, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/02/2015 ABRAXANE
NDA #021660		 SUPPL-42 PACLITAXEL BRISTOL-MYERS Manufacturing (CMC) Approval
11/02/2015 SOMATULINE DEPOT
NDA #022074		 SUPPL-14 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
11/02/2015 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #040248		 SUPPL-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE CHARTWELL Labeling Approval
11/02/2015 SANDIMMUNE
NDA #050573		 SUPPL-40 CYCLOSPORINE NOVARTIS Manufacturing (CMC) Approval
11/02/2015 GRIFULVIN V
ANDA #062483		 SUPPL-21 GRISEOFULVIN, MICROSIZE VALEANT LUXEMBOURG Labeling Approval
11/02/2015 CLAFORAN
ANDA #062659		 SUPPL-41 CEFOTAXIME SODIUM SANOFI AVENTIS US Labeling Approval
11/02/2015 PENTOXIFYLLINE
ANDA #075199		 SUPPL-3 PENTOXIFYLLINE ANI PHARMS Labeling Approval
11/02/2015 SERTRALINE HYDROCHLORIDE
ANDA #077299		 SUPPL-3 SERTRALINE HYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
11/02/2015 RISPERIDONE
ANDA #077769		 SUPPL-1 RISPERIDONE HERITAGE PHARMA AVET Labeling Approval
11/02/2015 PROMETH W/ DEXTROMETHORPHAN
ANDA #088762		 SUPPL-74 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE G AND W LABS INC Labeling Approval
11/02/2015 STENDRA
NDA #202276		 SUPPL-12 AVANAFIL METUCHEN PHARMS Manufacturing (CMC) Approval
11/02/2015 MYRBETRIQ
NDA #202611		 SUPPL-5 MIRABEGRON APGDI Labeling Approval
11/02/2015 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #204169		 ORIG-1 HYDROCHLOROTHIAZIDE; TELMISARTAN MACLEODS PHARMS LTD Approval
11/02/2015 AMMONIA N 13
ANDA #204510		 ORIG-1 AMMONIA N-13 PETNET Approval
11/03/2015 SABRIL
NDA #022006		 SUPPL-17 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
11/03/2015 VANCOMYCIN HYDROCHLORIDE
ANDA #062933		 SUPPL-27 VANCOMYCIN HYDROCHLORIDE HOSPIRA Labeling Approval
11/03/2015 HALOPERIDOL
ANDA #070714		 SUPPL-6 HALOPERIDOL LACTATE WATSON LABS Labeling Approval
11/03/2015 HALOPERIDOL
ANDA #070981		 SUPPL-11 HALOPERIDOL WATSON LABS Labeling Approval
11/03/2015 HALOPERIDOL
ANDA #070982		 SUPPL-12 HALOPERIDOL WATSON LABS Labeling Approval
11/03/2015 HALOPERIDOL
ANDA #070983		 SUPPL-12 HALOPERIDOL WATSON LABS Labeling Approval
11/03/2015 HALOPERIDOL
ANDA #070984		 SUPPL-10 HALOPERIDOL WATSON LABS Labeling Approval
11/03/2015 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073007		 SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
11/03/2015 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073008		 SUPPL-22 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
11/03/2015 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073009		 SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
11/03/2015 PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073010		 SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE CHARTWELL RX Labeling Approval
11/03/2015 CLONAZEPAM
ANDA #074940		 SUPPL-6 CLONAZEPAM MYLAN PHARMS INC Labeling Approval
11/03/2015 BUSPIRONE HYDROCHLORIDE
ANDA #075385		 SUPPL-10 BUSPIRONE HYDROCHLORIDE IVAX SUB TEVA PHARMS Labeling Approval
11/03/2015 CHLORPROMAZINE HYDROCHLORIDE
ANDA #080365		 SUPPL-165 CHLORPROMAZINE HYDROCHLORIDE DR REDDYS Labeling Approval
11/03/2015 OGEN .625
ANDA #083220		 SUPPL-42 ESTROPIPATE PFIZER Labeling Approval
11/03/2015 OGEN 1.25
ANDA #083220		 SUPPL-42 ESTROPIPATE PFIZER Labeling Approval
11/03/2015 OGEN 2.5
ANDA #083220		 SUPPL-42 ESTROPIPATE PFIZER Labeling Approval
11/03/2015 OGEN 5
ANDA #083220		 SUPPL-42 ESTROPIPATE PFIZER Labeling Approval
11/03/2015 OGEN
ANDA #084710		 SUPPL-22 ESTROPIPATE PHARMACIA AND UPJOHN Labeling Approval
11/03/2015 CHLORPROMAZINE HYDROCHLORIDE
ANDA #086863		 SUPPL-28 CHLORPROMAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088229		 SUPPL-24 THIORIDAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088476		 SUPPL-17 THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088477		 SUPPL-16 THIORIDAZINE HYDROCHLORIDE WATSON LABS TEVA Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088478		 SUPPL-17 THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088479		 SUPPL-16 THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088561		 SUPPL-23 THIORIDAZINE HYDROCHLORIDE WATSON LABS Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088563		 SUPPL-28 THIORIDAZINE HYDROCHLORIDE WATSON LABS Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088564		 SUPPL-25 THIORIDAZINE HYDROCHLORIDE WATSON LABS Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088567		 SUPPL-24 THIORIDAZINE HYDROCHLORIDE WATSON LABS TEVA Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088736		 SUPPL-11 THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088869		 SUPPL-12 THIORIDAZINE HYDROCHLORIDE WATSON LABS Labeling Approval
11/03/2015 THIORIDAZINE HYDROCHLORIDE
ANDA #088872		 SUPPL-13 THIORIDAZINE HYDROCHLORIDE WATSON LABS TEVA Labeling Approval
11/03/2015 PROCHLORPERAZINE EDISYLATE
ANDA #089523		 SUPPL-2 PROCHLORPERAZINE EDISYLATE HIKMA Labeling Approval
11/03/2015 PROCHLORPERAZINE EDISYLATE
ANDA #089530		 SUPPL-13 PROCHLORPERAZINE EDISYLATE WATSON LABS Labeling Approval
11/03/2015 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #089536		 SUPPL-25 ACETAMINOPHEN; BUTALBITAL; CAFFEINE WATSON LABS Labeling Approval
11/03/2015 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089997		 SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL Labeling Approval
11/03/2015 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089998		 SUPPL-16 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL Labeling Approval
11/03/2015 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #089999		 SUPPL-15 ACETAMINOPHEN; CODEINE PHOSPHATE CHARTWELL Labeling Approval
11/03/2015 GLUCAGON
NDA #201849		 SUPPL-1 GLUCAGON HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
11/03/2015 GLUCAGON
NDA #201849		 SUPPL-3 GLUCAGON HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
11/03/2015 SEVOFLURANE
ANDA #203793		 ORIG-1 SEVOFLURANE SHANGHAI HENGRUI Approval
11/04/2015 EFUDEX
NDA #016831		 SUPPL-59 FLUOROURACIL BAUSCH Manufacturing (CMC) Approval
11/04/2015 GABITRIL
NDA #020646		 SUPPL-18 TIAGABINE HYDROCHLORIDE CEPHALON Labeling Approval
11/04/2015 KETEK
NDA #021144		 SUPPL-19 TELITHROMYCIN SANOFI AVENTIS US Labeling Approval
11/04/2015 PHENTERMINE HYDROCHLORIDE
ANDA #040276		 SUPPL-15 PHENTERMINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
11/04/2015 HALOPERIDOL LACTATE
ANDA #074536		 SUPPL-1 HALOPERIDOL LACTATE ACTAVIS MID ATLANTIC Labeling Approval
11/04/2015 GABAPENTIN
ANDA #075477		 SUPPL-6 GABAPENTIN CSPC OUYI Labeling Approval
11/04/2015 OFLOXACIN
ANDA #076093		 SUPPL-3 OFLOXACIN LARKEN LABS Labeling Approval
11/04/2015 LEFLUNOMIDE
ANDA #077083		 SUPPL-6 LEFLUNOMIDE BARR Labeling Approval
11/04/2015 OXYBUTYNIN CHLORIDE
ANDA #078503		 SUPPL-5 OXYBUTYNIN CHLORIDE OSMOTICA PHARM US Labeling Approval
11/04/2015 OXYBUTYNIN CHLORIDE
ANDA #078503		 SUPPL-6 OXYBUTYNIN CHLORIDE OSMOTICA PHARM US Labeling Approval
11/04/2015 ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #085861		 SUPPL-70 ACETAMINOPHEN; CODEINE PHOSPHATE ACTAVIS MID ATLANTIC Labeling Approval
11/04/2015 CAPITAL AND CODEINE
ANDA #085883		 SUPPL-38 ACETAMINOPHEN; CODEINE PHOSPHATE ACTAVIS MID ATLANTIC Labeling Approval
11/04/2015 NUCALA
BLA #125526		 ORIG-1 MEPOLIZUMAB GLAXOSMITHKLINE LLC Approval
11/04/2015 FELBAMATE
ANDA #202284		 ORIG-1 FELBAMATE ANI PHARMS Approval
11/04/2015 IMPAVIDO
NDA #204684		 SUPPL-2 MILTEFOSINE KNIGHT THERAPS Manufacturing (CMC) Approval
11/05/2015 DDAVP
NDA #017922		 SUPPL-42 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
11/05/2015 DDAVP (NEEDS NO REFRIGERATION)
NDA #017922		 SUPPL-42 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
11/05/2015 DDAVP
NDA #018938		 SUPPL-29 DESMOPRESSIN ACETATE FERRING PHARMS INC Labeling Approval
11/05/2015 IOPIDINE
NDA #019779		 SUPPL-22 APRACLONIDINE HYDROCHLORIDE HARROW EYE Manufacturing (CMC) Approval
11/05/2015 LESCOL
NDA #020261		 SUPPL-50 FLUVASTATIN SODIUM NOVARTIS Manufacturing (CMC) Approval
11/05/2015 RAPAMUNE
NDA #021083		 SUPPL-58 SIROLIMUS PF PRISM CV Labeling Approval
11/05/2015 RAPAMUNE
NDA #021110		 SUPPL-75 SIROLIMUS PF PRISM CV Labeling Approval
11/05/2015 LESCOL XL
NDA #021192		 SUPPL-23 FLUVASTATIN SODIUM SANDOZ Manufacturing (CMC) Approval
11/05/2015 ZORTRESS
NDA #021560		 SUPPL-18 EVEROLIMUS NOVARTIS Labeling Approval
11/05/2015 HYDASE
BLA #021716		 SUPPL-3 HYALURONIDASE AKORN INC Approval
11/05/2015 MEGACE ES
NDA #021778		 SUPPL-22 MEGESTROL ACETATE ENDO PHARMS INC Manufacturing (CMC) Approval
11/05/2015 TREANDA
NDA #022249		 SUPPL-20 BENDAMUSTINE HYDROCHLORIDE CEPHALON Labeling Approval
11/05/2015 CARBAGLU
NDA #022562		 SUPPL-4 CARGLUMIC ACID RECORDATI RARE Manufacturing (CMC) Approval
11/05/2015 AZITHROMYCIN
ANDA #065507		 SUPPL-2 AZITHROMYCIN APOTEX CORP Labeling Approval
11/05/2015 AZITHROMYCIN
ANDA #065509		 SUPPL-2 AZITHROMYCIN APOTEX CORP Labeling Approval
11/05/2015 CARBIDOPA AND LEVODOPA
ANDA #073589		 SUPPL-25 CARBIDOPA; LEVODOPA DR REDDYS LABS SA Labeling Approval
11/05/2015 CARBIDOPA AND LEVODOPA
ANDA #073607		 SUPPL-28 CARBIDOPA; LEVODOPA DR REDDYS LABS SA Labeling Approval
11/05/2015 CARBIDOPA AND LEVODOPA
ANDA #073618		 SUPPL-27 CARBIDOPA; LEVODOPA DR REDDYS LABS SA Labeling Approval
11/05/2015 CLONAZEPAM
ANDA #074964		 SUPPL-18 CLONAZEPAM WATSON LABS Labeling Approval
11/05/2015 PAMIDRONATE DISODIUM
ANDA #076153		 SUPPL-28 PAMIDRONATE DISODIUM TEVA PHARMS USA Labeling Approval
11/05/2015 TESTOSTERONE
ANDA #076737		 SUPPL-6 TESTOSTERONE ACTAVIS LABS UT INC REMS Approval
11/05/2015 IRBESARTAN
ANDA #077466		 SUPPL-6 IRBESARTAN SANDOZ Labeling Approval
11/05/2015 ANASTROZOLE
ANDA #078485		 SUPPL-6 ANASTROZOLE HIKMA Labeling Approval
11/05/2015 ANASTROZOLE
ANDA #078485		 SUPPL-7 ANASTROZOLE HIKMA Labeling Approval
11/05/2015 QUETIAPINE FUMARATE
ANDA #078679		 SUPPL-7 QUETIAPINE FUMARATE SANDOZ Labeling Approval
11/05/2015 QUETIAPINE FUMARATE
ANDA #078679		 SUPPL-8 QUETIAPINE FUMARATE SANDOZ Labeling Approval
11/05/2015 ZOLPIDEM TARTRATE
ANDA #078970		 SUPPL-3 ZOLPIDEM TARTRATE LUPIN LTD Labeling Approval
11/05/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #090150		 SUPPL-4 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM APOTEX Labeling Approval
11/05/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090764		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE MYLAN Labeling Approval
11/05/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090764		 SUPPL-8 PRAMIPEXOLE DIHYDROCHLORIDE MYLAN Labeling Approval
11/05/2015 SIMVASTATIN
ANDA #200895		 SUPPL-1 SIMVASTATIN HETERO LABS LTD III Labeling Approval
11/05/2015 SIMVASTATIN
ANDA #200895		 SUPPL-2 SIMVASTATIN HETERO LABS LTD III Labeling Approval
11/05/2015 ADVIL
NDA #201803		 SUPPL-6 IBUPROFEN SODIUM HALEON US HOLDINGS Manufacturing (CMC) Approval
11/05/2015 OLANZAPINE
ANDA #202862		 SUPPL-1 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/05/2015 OLANZAPINE
ANDA #202862		 SUPPL-3 OLANZAPINE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
11/05/2015 OLANZAPINE
ANDA #202862		 SUPPL-5 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/05/2015 CLOPIDOGREL BISULFATE
ANDA #202925		 SUPPL-2 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
11/05/2015 CLOPIDOGREL BISULFATE
ANDA #202925		 SUPPL-3 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
11/05/2015 CLOPIDOGREL BISULFATE
ANDA #202925		 SUPPL-4 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
11/05/2015 CLOPIDOGREL BISULFATE
ANDA #202925		 SUPPL-5 CLOPIDOGREL BISULFATE ACCORD HLTHCARE Labeling Approval
11/05/2015 SPIRONOLACTONE
ANDA #203253		 SUPPL-2 SPIRONOLACTONE JUBILANT GENERICS Labeling Approval
11/05/2015 JUBLIA
NDA #203567		 SUPPL-4 EFINACONAZOLE BAUSCH Manufacturing (CMC) Approval
11/05/2015 SIMBRINZA
NDA #204251		 SUPPL-6 BRIMONIDINE TARTRATE; BRINZOLAMIDE ALCON LABS INC Labeling Approval
11/05/2015 TIVICAY
NDA #204790		 SUPPL-6 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Manufacturing (CMC) Approval
11/05/2015 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #204802		 ORIG-1 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE MACLEODS PHARMS LTD Approval
11/05/2015 MONTELUKAST SODIUM
ANDA #205695		 ORIG-1 MONTELUKAST SODIUM ANBISON LAB Approval
11/05/2015 POTASSIUM CHLORIDE
ANDA #205993		 ORIG-1 POTASSIUM CHLORIDE PADAGIS US Approval
11/05/2015 GENVOYA
NDA #207561		 ORIG-1 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Type 1 - New Molecular Entity and Type 4 - New Combination Approval
11/06/2015 BSS PLUS
NDA #018469		 SUPPL-54 CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE ALCON Labeling Approval
11/06/2015 BSS PLUS
NDA #018469		 SUPPL-55 CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE ALCON Manufacturing (CMC) Approval
11/06/2015 TOPICORT
NDA #018594		 SUPPL-12 DESOXIMETASONE TARO Manufacturing (CMC) Approval
11/06/2015 FIORINAL W/CODEINE
NDA #019429		 SUPPL-38 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ALLERGAN Manufacturing (CMC) Approval
11/06/2015 BSS
NDA #020742		 SUPPL-25 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE ALCON Labeling Approval
11/06/2015 BSS
NDA #020742		 SUPPL-26 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE ALCON Manufacturing (CMC) Approval
11/06/2015 BROVANA
NDA #021912		 SUPPL-27 ARFORMOTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
11/06/2015 CUVPOSA
NDA #022571		 SUPPL-4 GLYCOPYRROLATE MERZ PHARMS Labeling Approval
11/06/2015 MYCOPHENOLATE MOFETIL
ANDA #065416		 SUPPL-12 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE Labeling Approval
11/06/2015 RIZATRIPTAN BENZOATE
ANDA #077263		 SUPPL-1 RIZATRIPTAN BENZOATE TEVA PHARMS Labeling Approval
11/06/2015 MYCOPHENOLATE MOFETIL
ANDA #090253		 SUPPL-12 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE Labeling Approval
11/06/2015 IRBESARTAN
ANDA #202910		 SUPPL-1 IRBESARTAN HETERO LABS LTD V Labeling Approval
11/06/2015 MYCOPHENOLATE MOFETIL
ANDA #203005		 SUPPL-2 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
11/06/2015 XTANDI
NDA #203415		 SUPPL-8 ENZALUTAMIDE ASTELLAS Manufacturing (CMC) Approval
11/06/2015 SAVAYSA
NDA #206316		 SUPPL-5 EDOXABAN TOSYLATE DAIICHI SANKYO INC Manufacturing (CMC) Approval
11/06/2015 JADENU
NDA #206910		 SUPPL-2 DEFERASIROX NOVARTIS PHARMS CORP Manufacturing (CMC) Approval
11/06/2015 ULTRAVATE
NDA #208183		 ORIG-1 HALOBETASOL PROPIONATE SUN PHARM INDUSTRIES Type 3 - New Dosage Form Approval
11/09/2015 FENTANYL CITRATE
NDA #019101		 SUPPL-42 FENTANYL CITRATE HIKMA Manufacturing (CMC) Approval
11/09/2015 AGGRENOX
NDA #020884		 SUPPL-35 ASPIRIN; DIPYRIDAMOLE BOEHRINGER INGELHEIM Labeling Approval
11/09/2015 PROTONIX IV
NDA #020988		 SUPPL-53 PANTOPRAZOLE SODIUM WYETH PHARMS Manufacturing (CMC) Approval
11/09/2015 THYRO-TABS
NDA #021116		 SUPPL-14 LEVOTHYROXINE SODIUM ALVOGEN Manufacturing (CMC) Approval
11/09/2015 FOLLISTIM AQ
BLA #021211		 SUPPL-16 FOLLITROPIN ALFA/BETA ORGANON USA INC Approval
11/09/2015 DAYTRANA
NDA #021514		 SUPPL-18 METHYLPHENIDATE NOVEN PHARMS INC Manufacturing (CMC) Approval
11/09/2015 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
NDA #050821		 SUPPL-4 CEFEPIME HYDROCHLORIDE B BRAUN Labeling Approval
11/09/2015 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-20 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
11/09/2015 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-19 MYCOPHENOLATE MOFETIL SANDOZ Labeling Approval
11/09/2015 VERAPAMIL HYDROCHLORIDE
ANDA #071483		 SUPPL-25 VERAPAMIL HYDROCHLORIDE RISING Labeling Approval
11/09/2015 CLOTRIMAZOLE
ANDA #074165		 SUPPL-39 CLOTRIMAZOLE P AND L Manufacturing (CMC) Approval
11/09/2015 CAPTOPRIL
ANDA #074434		 SUPPL-15 CAPTOPRIL AUROBINDO PHARMA USA Labeling Approval
11/09/2015 TRAMADOL HYDROCHLORIDE
ANDA #075977		 SUPPL-11 TRAMADOL HYDROCHLORIDE TEVA Labeling Approval
11/09/2015 TRAMADOL HYDROCHLORIDE
ANDA #075986		 SUPPL-13 TRAMADOL HYDROCHLORIDE MYLAN Labeling Approval
11/09/2015 LEFLUNOMIDE
ANDA #077087		 SUPPL-11 LEFLUNOMIDE WANBANG BIOPHARMS Labeling Approval
11/09/2015 LEFLUNOMIDE
ANDA #077087		 SUPPL-12 LEFLUNOMIDE WANBANG BIOPHARMS Labeling Approval
11/09/2015 RIZATRIPTAN BENZOATE
ANDA #078173		 SUPPL-5 RIZATRIPTAN BENZOATE MYLAN PHARMS INC Labeling Approval
11/09/2015 IRBESARTAN
ANDA #090201		 SUPPL-2 IRBESARTAN HIKMA Labeling Approval
11/09/2015 TRAMADOL HYDROCHLORIDE
ANDA #090404		 SUPPL-3 TRAMADOL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/09/2015 GALANTAMINE HYDROBROMIDE
ANDA #090900		 SUPPL-4 GALANTAMINE HYDROBROMIDE MYLAN Labeling Approval
11/09/2015 GALANTAMINE HYDROBROMIDE
ANDA #090900		 SUPPL-5 GALANTAMINE HYDROBROMIDE MYLAN Labeling Approval
11/09/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #090931		 SUPPL-3 TAMSULOSIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/09/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #090931		 SUPPL-4 TAMSULOSIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/09/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #090931		 SUPPL-6 TAMSULOSIN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/09/2015 ATORVASTATIN CALCIUM
ANDA #091226		 SUPPL-8 ATORVASTATIN CALCIUM MYLAN PHARMS INC Labeling Approval
11/09/2015 GILOTRIF
NDA #201292		 SUPPL-6 AFATINIB DIMALEATE BOEHRINGER INGELHEIM Efficacy Approval
11/09/2015 TEMOZOLOMIDE
ANDA #201742		 SUPPL-7 TEMOZOLOMIDE SUN PHARM Labeling Approval
11/09/2015 ZOLEDRONIC ACID
ANDA #201783		 SUPPL-9 ZOLEDRONIC ACID AVET LIFESCIENCES Labeling Approval
11/09/2015 TRETINOIN
ANDA #202026		 SUPPL-1 TRETINOIN MYLAN Labeling Approval
11/09/2015 VALSARTAN
ANDA #202223		 SUPPL-2 VALSARTAN AUROBINDO PHARMA LTD Labeling Approval
11/09/2015 RIZATRIPTAN BENZOATE
ANDA #202490		 SUPPL-4 RIZATRIPTAN BENZOATE AUROBINDO PHARMA LTD Labeling Approval
11/09/2015 TRETINOIN
ANDA #202567		 SUPPL-1 TRETINOIN MYLAN Labeling Approval
11/09/2015 RIZATRIPTAN BENZOATE
ANDA #203062		 SUPPL-1 RIZATRIPTAN BENZOATE AUROBINDO PHARMA LTD Labeling Approval
11/09/2015 PALONOSETRON HYDROCHLORIDE
ANDA #204731		 ORIG-1 PALONOSETRON HYDROCHLORIDE AKORN INC Tentative Approval
11/09/2015 ALMOTRIPTAN MALATE
ANDA #205171		 ORIG-1 ALMOTRIPTAN MALATE MYLAN Approval
11/09/2015 NEVIRAPINE
ANDA #206271		 ORIG-1 NEVIRAPINE MYLAN Approval
11/10/2015 FLUOCINONIDE
NDA #019117		 SUPPL-39 FLUOCINONIDE TARO Manufacturing (CMC) Approval
11/10/2015 CLOZARIL
NDA #019758		 SUPPL-76 CLOZAPINE HERITAGE LIFE Manufacturing (CMC) Approval
11/10/2015 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-23 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/10/2015 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-23 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/10/2015 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-23 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/10/2015 NORVIR
NDA #020659		 SUPPL-62 RITONAVIR ABBVIE Labeling Approval
11/10/2015 AZOPT
NDA #020816		 SUPPL-19 BRINZOLAMIDE SANDOZ Labeling Approval
11/10/2015 NORVIR
NDA #020945		 SUPPL-40 RITONAVIR ABBVIE Labeling Approval
11/10/2015 KALETRA
NDA #021226		 SUPPL-42 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/10/2015 KALETRA
NDA #021251		 SUPPL-51 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/10/2015 RANEXA
NDA #021526		 SUPPL-30 RANOLAZINE MENARINI INTL Manufacturing (CMC) Approval
11/10/2015 QOLIANA
NDA #021764		 SUPPL-9 BRIMONIDINE TARTRATE SANDOZ Manufacturing (CMC) Approval
11/10/2015 KALETRA
NDA #021906		 SUPPL-44 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/10/2015 BESIVANCE
NDA #022308		 SUPPL-11 BESIFLOXACIN HYDROCHLORIDE BAUSCH AND LOMB Manufacturing (CMC) Approval
11/10/2015 EMBEDA
NDA #022321		 SUPPL-20 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Manufacturing (CMC) Approval
11/10/2015 NORVIR
NDA #022417		 SUPPL-14 RITONAVIR ABBVIE Labeling Approval
11/10/2015 STREPTOMYCIN SULFATE
ANDA #064210		 SUPPL-12 STREPTOMYCIN SULFATE XGEN PHARMS Labeling Approval
11/10/2015 PIPERACILLIN AND TAZOBACTAM
ANDA #065362		 SUPPL-7 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Labeling Approval
11/10/2015 ACEPHEN
ANDA #072237		 SUPPL-11 ACETAMINOPHEN COSETTE Labeling Approval
11/10/2015 ACEPHEN
ANDA #072237		 SUPPL-14 ACETAMINOPHEN COSETTE Labeling Approval
11/10/2015 MOMETASONE FUROATE
ANDA #076171		 SUPPL-3 MOMETASONE FUROATE FOUGERA PHARMS Labeling Approval
11/10/2015 MOMETASONE FUROATE
ANDA #076624		 SUPPL-6 MOMETASONE FUROATE TARO Labeling Approval
11/10/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076794		 SUPPL-31 CIPROFLOXACIN HYDROCHLORIDE WATSON LABS Labeling Approval
11/10/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076794		 SUPPL-34 CIPROFLOXACIN HYDROCHLORIDE WATSON LABS Labeling Approval
11/10/2015 BUPROPION HYDROCHLORIDE
ANDA #077475		 SUPPL-16 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
11/10/2015 BUPROPION HYDROCHLORIDE
ANDA #077475		 SUPPL-17 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
11/10/2015 GALANTAMINE HYDROBROMIDE
ANDA #077590		 SUPPL-8 GALANTAMINE HYDROBROMIDE MYLAN Labeling Approval
11/10/2015 GALANTAMINE HYDROBROMIDE
ANDA #077590		 SUPPL-9 GALANTAMINE HYDROBROMIDE MYLAN Labeling Approval
11/10/2015 GALANTAMINE HYDROBROMIDE
ANDA #077605		 SUPPL-8 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
11/10/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077948		 SUPPL-7 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM SANDOZ Labeling Approval
11/10/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077948		 SUPPL-9 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM SANDOZ Labeling Approval
11/10/2015 GALANTAMINE HYDROBROMIDE
ANDA #078189		 SUPPL-8 GALANTAMINE HYDROBROMIDE BARR Labeling Approval
11/10/2015 SILDENAFIL CITRATE
ANDA #078380		 SUPPL-3 SILDENAFIL CITRATE TEVA PHARMS Labeling Approval
11/10/2015 MOMETASONE FUROATE
ANDA #078541		 SUPPL-8 MOMETASONE FUROATE GLENMARK PHARMS INC Labeling Approval
11/10/2015 CELECOXIB
ANDA #078857		 SUPPL-1 CELECOXIB MYLAN Manufacturing (CMC) Approval
11/10/2015 SUMATRIPTAN SUCCINATE
ANDA #090314		 SUPPL-2 SUMATRIPTAN SUCCINATE STERISCIENCE Manufacturing (CMC) Approval
11/10/2015 SUMATRIPTAN SUCCINATE
ANDA #090314		 SUPPL-4 SUMATRIPTAN SUCCINATE STERISCIENCE Labeling Approval
11/10/2015 BUPROPION HYDROCHLORIDE
ANDA #201567		 SUPPL-5 BUPROPION HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
11/10/2015 ILEVRO
NDA #203491		 SUPPL-9 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
11/10/2015 COTELLIC
NDA #206192		 ORIG-1 COBIMETINIB FUMARATE GENENTECH INC Type 1 - New Molecular Entity Approval
11/10/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #206721		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE MYLAN Approval
11/12/2015 CLARITIN
NDA #020641		 SUPPL-38 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
11/12/2015 CLARITIN HIVES RELIEF
NDA #020641		 SUPPL-38 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
11/12/2015 ZONEGRAN
NDA #020789		 SUPPL-33 ZONISAMIDE CONCORDIA Manufacturing (CMC) Approval
11/12/2015 AVAGARD
NDA #021074		 SUPPL-10 ALCOHOL; CHLORHEXIDINE GLUCONATE 3M Labeling Approval
11/12/2015 IONSYS
NDA #021338		 SUPPL-6 FENTANYL HYDROCHLORIDE THE MEDICINES CO REMS Approval
11/12/2015 MIRALAX
NDA #022015		 SUPPL-24 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Labeling Approval
11/12/2015 FLUDARABINE PHOSPHATE
NDA #022137		 SUPPL-12 FLUDARABINE PHOSPHATE SANDOZ Manufacturing (CMC) Approval
11/12/2015 OXYCONTIN
NDA #022272		 SUPPL-30 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Manufacturing (CMC) Approval
11/12/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076118		 SUPPL-20 BENAZEPRIL HYDROCHLORIDE PRINSTON INC Labeling Approval
11/12/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #076118		 SUPPL-21 BENAZEPRIL HYDROCHLORIDE PRINSTON INC Labeling Approval
11/12/2015 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #076516		 SUPPL-9 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE FOUGERA PHARMS Labeling Approval
11/12/2015 IRBESARTAN
ANDA #077159		 SUPPL-7 IRBESARTAN TEVA PHARMS Labeling Approval
11/12/2015 METOPROLOL TARTRATE
ANDA #077761		 SUPPL-16 METOPROLOL TARTRATE HIKMA FARMACEUTICA Labeling Approval
11/12/2015 BENAZEPRIL HYDROCHLORIDE
ANDA #078212		 SUPPL-15 BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
11/12/2015 MONTELUKAST SODIUM
ANDA #078605		 SUPPL-8 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
11/12/2015 MONTELUKAST SODIUM
ANDA #078723		 SUPPL-8 MONTELUKAST SODIUM TEVA PHARMS Labeling Approval
11/12/2015 RISPERIDONE
ANDA #079158		 SUPPL-10 RISPERIDONE LANNETT CO INC Labeling Approval
11/12/2015 ROCURONIUM BROMIDE
ANDA #079199		 SUPPL-6 ROCURONIUM BROMIDE MYLAN INSTITUTIONAL Labeling Approval
11/12/2015 IRBESARTAN
ANDA #079213		 SUPPL-1 IRBESARTAN ZYDUS PHARMS USA INC Labeling Approval
11/12/2015 ESCITALOPRAM OXALATE
ANDA #090432		 SUPPL-9 ESCITALOPRAM OXALATE AUROBINDO PHARMA LTD Labeling Approval
11/12/2015 LOSARTAN POTASSIUM
ANDA #202230		 SUPPL-5 LOSARTAN POTASSIUM MACLEODS PHARMS LTD Labeling Approval
11/12/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202580		 SUPPL-3 DEXMETHYLPHENIDATE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
11/12/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #203870		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE AMNEAL PHARMS Approval
11/12/2015 CARISOPRODOL
ANDA #205513		 ORIG-1 CARISOPRODOL STRIDES PHARMA Approval
11/12/2015 HARVONI
NDA #205834		 SUPPL-2 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/12/2015 HARVONI
NDA #205834		 SUPPL-3 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/12/2015 HARVONI
NDA #205834		 SUPPL-4 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/12/2015 HARVONI
NDA #205834		 SUPPL-5 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/12/2015 HARVONI
NDA #205834		 SUPPL-6 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Efficacy Approval
11/12/2015 TRIFERIC
NDA #206317		 SUPPL-4 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Manufacturing (CMC) Approval
11/12/2015 ENTECAVIR
ANDA #206652		 ORIG-1 ENTECAVIR AMNEAL PHARMS Approval
11/13/2015 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-71 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/13/2015 HEPARIN SODIUM
NDA #017651		 SUPPL-58 HEPARIN SODIUM FRESENIUS KABI USA Manufacturing (CMC) Approval
11/13/2015 ALLOPURINOL
NDA #018877		 SUPPL-62 ALLOPURINOL WATSON LABS Manufacturing (CMC) Approval
11/13/2015 DIOVAN HCT
NDA #020818		 SUPPL-67 HYDROCHLOROTHIAZIDE; VALSARTAN NOVARTIS Manufacturing (CMC) Approval
11/13/2015 EXELON
NDA #020823		 SUPPL-33 RIVASTIGMINE TARTRATE NOVARTIS Manufacturing (CMC) Approval
11/13/2015 TRIGLIDE
NDA #021350		 SUPPL-15 FENOFIBRATE SKYEPHARMA AG Labeling Approval
11/13/2015 NOXAFIL
NDA #022003		 SUPPL-18 POSACONAZOLE SCHERING Labeling Approval
11/13/2015 NOXAFIL
NDA #022003		 SUPPL-20 POSACONAZOLE SCHERING Labeling Approval
11/13/2015 DORIBAX
NDA #022106		 SUPPL-16 DORIPENEM SHIONOGI INC Manufacturing (CMC) Approval
11/13/2015 INTERMEZZO
NDA #022328		 SUPPL-3 ZOLPIDEM TARTRATE PURDUE PHARMA Manufacturing (CMC) Approval
11/13/2015 TROPICAMIDE
ANDA #040064		 SUPPL-24 TROPICAMIDE BAUSCH AND LOMB Labeling Approval
11/13/2015 TROPICAMIDE
ANDA #040067		 SUPPL-24 TROPICAMIDE BAUSCH AND LOMB Labeling Approval
11/13/2015 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #050671		 SUPPL-21 VANCOMYCIN HYDROCHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
11/13/2015 CELLCEPT
NDA #050722		 SUPPL-34 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
11/13/2015 CELLCEPT
NDA #050723		 SUPPL-33 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
11/13/2015 CELLCEPT
NDA #050758		 SUPPL-31 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE PALO REMS Approval
11/13/2015 CELLCEPT
NDA #050759		 SUPPL-40 MYCOPHENOLATE MOFETIL ROCHE PALO REMS Approval
11/13/2015 MYFORTIC
NDA #050791		 SUPPL-22 MYCOPHENOLIC SODIUM NOVARTIS REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065379		 SUPPL-18 MYCOPHENOLATE MOFETIL SANDOZ REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065410		 SUPPL-9 MYCOPHENOLATE MOFETIL HIKMA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065413		 SUPPL-10 MYCOPHENOLATE MOFETIL HIKMA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065416		 SUPPL-11 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065451		 SUPPL-18 MYCOPHENOLATE MOFETIL SANDOZ REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065457		 SUPPL-9 MYCOPHENOLATE MOFETIL TEVA PHARMS REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065491		 SUPPL-9 MYCOPHENOLATE MOFETIL TEVA PHARMS REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065520		 SUPPL-16 MYCOPHENOLATE MOFETIL MYLAN REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #065521		 SUPPL-13 MYCOPHENOLATE MOFETIL MYLAN REMS Approval
11/13/2015 TRAMADOL HYDROCHLORIDE
ANDA #075981		 SUPPL-13 TRAMADOL HYDROCHLORIDE APOTEX Labeling Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090055		 SUPPL-5 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090111		 SUPPL-8 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090253		 SUPPL-11 MYCOPHENOLATE MOFETIL ACCORD HLTHCARE REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090419		 SUPPL-9 MYCOPHENOLATE MOFETIL APOTEX CORP REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090456		 SUPPL-7 MYCOPHENOLATE MOFETIL STRIDES PHARMA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090499		 SUPPL-10 MYCOPHENOLATE MOFETIL APOTEX REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090606		 SUPPL-7 MYCOPHENOLATE MOFETIL AMNEAL REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090661		 SUPPL-2 MYCOPHENOLATE MOFETIL JUBILANT CADISTA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #090762		 SUPPL-2 MYCOPHENOLATE MOFETIL JUBILANT CADISTA REMS Approval
11/13/2015 MYCOPHENOLIC SODIUM
ANDA #091248		 SUPPL-3 MYCOPHENOLIC SODIUM RK PHARMA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #091249		 SUPPL-6 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
11/13/2015 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #091351		 SUPPL-1 HYDROCHLOROTHIAZIDE; TELMISARTAN LUPIN LTD Labeling Approval
11/13/2015 MYCOPHENOLIC SODIUM
ANDA #091558		 SUPPL-6 MYCOPHENOLIC SODIUM APOTEX INC REMS Approval
11/13/2015 NEULASTA
BLA #125031		 SUPPL-180 PEGFILGRASTIM AMGEN Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #200197		 SUPPL-3 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
11/13/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673		 SUPPL-1 LEVOCETIRIZINE DIHYDROCHLORIDE TARO Labeling Approval
11/13/2015 MYCOPHENOLIC SODIUM
ANDA #202720		 SUPPL-1 MYCOPHENOLIC SODIUM TEVA PHARMS USA REMS Approval
11/13/2015 MYCOPHENOLATE MOFETIL
ANDA #203005		 SUPPL-1 MYCOPHENOLATE MOFETIL ALKEM LABS LTD REMS Approval
11/13/2015 FLUDEOXYGLUCOSE F18
ANDA #203603		 ORIG-1 FLUDEOXYGLUCOSE F-18 CARDINAL HEALTH 414 Approval
11/13/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #203871		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL AMNEAL PHARMS Approval
11/13/2015 NOXAFIL
NDA #205053		 SUPPL-2 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
11/13/2015 NOXAFIL
NDA #205053		 SUPPL-4 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
11/13/2015 NOXAFIL
NDA #205596		 SUPPL-1 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
11/13/2015 NOXAFIL
NDA #205596		 SUPPL-3 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
11/13/2015 UCERIS
NDA #205613		 SUPPL-1 BUDESONIDE SALIX Manufacturing (CMC) Approval
11/13/2015 CHOLINE C-11
ANDA #206319		 ORIG-1 CHOLINE C-11 DECATUR Approval
11/13/2015 ABACAVIR; LAMIVUDINE
NDA #207369		 ORIG-1 ABACAVIR;LAMIVUDINE HETERO LABS LTD V Type 5 - New Formulation or New Manufacturer Tentative Approval
11/13/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207884		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Approval
11/13/2015 LONSURF
NDA #207981		 SUPPL-1 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Manufacturing (CMC) Approval
11/13/2015 TAGRISSO
NDA #208065		 ORIG-1 OSIMERTINIB MESYLATE ASTRAZENECA Type 1 - New Molecular Entity Approval
11/16/2015 SUTENT
NDA #021938		 SUPPL-31 SUNITINIB MALATE CPPI CV Labeling Approval
11/16/2015 RISEDRONATE SODIUM
ANDA #077132		 SUPPL-3 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
11/16/2015 RISEDRONATE SODIUM
ANDA #077132		 SUPPL-6 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
11/16/2015 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #200465		 SUPPL-2 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM MYLAN Labeling Approval
11/16/2015 OXYCODONE HYDROCHLORIDE
NDA #200534		 SUPPL-5 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Manufacturing (CMC) Approval
11/16/2015 CEFOXITIN IN PLASTIC CONTAINER
ANDA #200938		 ORIG-1 CEFOXITIN SODIUM SAMSON MEDCL Approval
11/16/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #202010		 SUPPL-2 TAMSULOSIN HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
11/16/2015 TAMSULOSIN HYDROCHLORIDE
ANDA #202010		 SUPPL-5 TAMSULOSIN HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
11/16/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202253		 SUPPL-5 ONDANSETRON HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/16/2015 DICLOFENAC SODIUM
ANDA #203383		 ORIG-1 DICLOFENAC SODIUM ALTAIRE PHARMS INC Approval
11/16/2015 INJECTAFER
NDA #203565		 SUPPL-4 FERRIC CARBOXYMALTOSE AM REGENT Manufacturing (CMC) Approval
11/16/2015 DARZALEX
BLA #761036		 ORIG-1 DARATUMUMAB JANSSEN BIOTECH Approval
11/17/2015 HABITROL
NDA #020076		 SUPPL-37 NICOTINE DR REDDYS LABS SA Manufacturing (CMC) Approval
11/17/2015 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-26 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Manufacturing (CMC) Approval
11/17/2015 GONAL-F
BLA #021765		 SUPPL-11 FOLLITROPIN ALFA/BETA EMD SERONO Approval
11/17/2015 GONAL-F RFF
BLA #021765		 SUPPL-11 FOLLITROPIN ALFA/BETA EMD SERONO Approval
11/17/2015 PRAZOSIN HYDROCHLORIDE
ANDA #072575		 SUPPL-17 PRAZOSIN HYDROCHLORIDE MYLAN Labeling Approval
11/17/2015 PRAZOSIN HYDROCHLORIDE
ANDA #072575		 SUPPL-18 PRAZOSIN HYDROCHLORIDE MYLAN Labeling Approval
11/17/2015 LEUPROLIDE ACETATE
ANDA #074728		 SUPPL-14 LEUPROLIDE ACETATE SANDOZ Labeling Approval
11/17/2015 LABETALOL HYDROCHLORIDE
ANDA #075240		 SUPPL-12 LABETALOL HYDROCHLORIDE HOSPIRA Labeling Approval
11/17/2015 LABETALOL HYDROCHLORIDE
ANDA #075240		 SUPPL-13 LABETALOL HYDROCHLORIDE HOSPIRA Labeling Approval
11/17/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075685		 SUPPL-12 CIPROFLOXACIN HYDROCHLORIDE MYLAN Labeling Approval
11/17/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075685		 SUPPL-13 CIPROFLOXACIN HYDROCHLORIDE MYLAN Labeling Approval
11/17/2015 TIOCONAZOLE
ANDA #075915		 SUPPL-25 TIOCONAZOLE PERRIGO Labeling Approval
11/17/2015 ITRACONAZOLE
ANDA #076104		 SUPPL-16 ITRACONAZOLE SANDOZ Labeling Approval
11/17/2015 ITRACONAZOLE
ANDA #076104		 SUPPL-18 ITRACONAZOLE SANDOZ Labeling Approval
11/17/2015 CARBIDOPA AND LEVODOPA
ANDA #076212		 SUPPL-11 CARBIDOPA; LEVODOPA APOTEX Labeling Approval
11/17/2015 LEVOCARNITINE
ANDA #076858		 SUPPL-6 LEVOCARNITINE RISING Labeling Approval
11/17/2015 RIVASTIGMINE TARTRATE
ANDA #077131		 SUPPL-4 RIVASTIGMINE TARTRATE SUN PHARM Labeling Approval
11/17/2015 GALANTAMINE HYDROBROMIDE
ANDA #078185		 SUPPL-1 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
11/17/2015 GALANTAMINE HYDROBROMIDE
ANDA #078185		 SUPPL-2 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
11/17/2015 GALANTAMINE HYDROBROMIDE
ANDA #078185		 SUPPL-4 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
11/17/2015 TELMISARTAN
ANDA #090032		 SUPPL-2 TELMISARTAN GLENMARK PHARMS LTD Labeling Approval
11/17/2015 ROPINIROLE HYDROCHLORIDE
ANDA #090135		 SUPPL-7 ROPINIROLE HYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
11/17/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090151		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE ZENNOVA Labeling Approval
11/17/2015 RIVASTIGMINE TARTRATE
ANDA #091689		 SUPPL-1 RIVASTIGMINE TARTRATE ALEMBIC PHARMS LTD Labeling Approval
11/17/2015 RIVASTIGMINE TARTRATE
ANDA #091689		 SUPPL-2 RIVASTIGMINE TARTRATE ALEMBIC PHARMS LTD Labeling Approval
11/17/2015 RISEDRONATE SODIUM
ANDA #200477		 SUPPL-2 RISEDRONATE SODIUM MYLAN Labeling Approval
11/17/2015 LEVALBUTEROL HYDROCHLORIDE
ANDA #200875		 SUPPL-1 LEVALBUTEROL HYDROCHLORIDE TEVA PARENTERAL Labeling Approval
11/17/2015 LEVALBUTEROL HYDROCHLORIDE
ANDA #200875		 SUPPL-2 LEVALBUTEROL HYDROCHLORIDE TEVA PARENTERAL Labeling Approval
11/17/2015 TOPOTECAN HYDROCHLORIDE
ANDA #202351		 SUPPL-1 TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
11/17/2015 TOPOTECAN HYDROCHLORIDE
ANDA #202351		 SUPPL-3 TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
11/17/2015 TELMISARTAN AND AMLODIPINE
ANDA #202516		 SUPPL-3 AMLODIPINE BESYLATE; TELMISARTAN MYLAN Labeling Approval
11/17/2015 IRBESARTAN
ANDA #203071		 SUPPL-1 IRBESARTAN PRINSTON INC Labeling Approval
11/17/2015 RIVASTIGMINE TARTRATE
ANDA #203148		 SUPPL-1 RIVASTIGMINE TARTRATE MACLEODS PHARMS LTD Labeling Approval
11/17/2015 ACETYLCYSTEINE
ANDA #203624		 ORIG-1 ACETYLCYSTEINE RISING Tentative Approval
11/17/2015 METHAMPHETAMINE HYDROCHLORIDE
ANDA #203846		 ORIG-1 METHAMPHETAMINE HYDROCHLORIDE HIKMA Approval
11/17/2015 TELMISARTAN
ANDA #203867		 SUPPL-2 TELMISARTAN SANDOZ Labeling Approval
11/17/2015 TELMISARTAN
ANDA #203867		 SUPPL-4 TELMISARTAN SANDOZ Labeling Approval
11/17/2015 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-1 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
11/17/2015 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-2 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
11/17/2015 OPSUMIT
NDA #204410		 SUPPL-2 MACITENTAN ACTELION REMS Approval
11/17/2015 SODIUM FLUORIDE F-18
ANDA #204440		 ORIG-1 SODIUM FLUORIDE F-18 MIDWEST MEDCL Approval
11/17/2015 SODIUM FLUORIDE F-18
ANDA #204462		 ORIG-1 SODIUM FLUORIDE F-18 UIHC PET IMAGING Approval
11/17/2015 HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #205658		 ORIG-1 HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE MAYNE PHARMA INC Approval
11/17/2015 MEMANTINE HYDROCHLORIDE
ANDA #206855		 ORIG-1 MEMANTINE HYDROCHLORIDE PURACAP PHARM LLC Approval
11/18/2015 VIREAD
NDA #021356		 SUPPL-51 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Manufacturing (CMC) Approval
11/18/2015 TRILIPIX
NDA #022224		 SUPPL-12 CHOLINE FENOFIBRATE ABBVIE Manufacturing (CMC) Approval
11/18/2015 OMNICEF
NDA #050739		 SUPPL-17 CEFDINIR ABBVIE Labeling Approval
11/18/2015 OMNICEF
NDA #050749		 SUPPL-23 CEFDINIR ABBVIE Labeling Approval
11/18/2015 MUPIROCIN
ANDA #065170		 SUPPL-12 MUPIROCIN TARO Labeling Approval
11/18/2015 MUPIROCIN
ANDA #065170		 SUPPL-13 MUPIROCIN TARO Labeling Approval
11/18/2015 MESNA
ANDA #075811		 SUPPL-12 MESNA FRESENIUS KABI USA Labeling Approval
11/18/2015 IPRATROPIUM BROMIDE
ANDA #076155		 SUPPL-22 IPRATROPIUM BROMIDE APOTEX INC Labeling Approval
11/18/2015 IPRATROPIUM BROMIDE
ANDA #076156		 SUPPL-20 IPRATROPIUM BROMIDE APOTEX INC Labeling Approval
11/18/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674		 SUPPL-14 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
11/18/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674		 SUPPL-16 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
11/18/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674		 SUPPL-17 HYDROCHLOROTHIAZIDE; LISINOPRIL COREPHARMA Labeling Approval
11/18/2015 IRBESARTAN
ANDA #077205		 SUPPL-1 IRBESARTAN CHARTWELL MOLECULAR Labeling Approval
11/18/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-18 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
11/18/2015 LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606		 SUPPL-19 HYDROCHLOROTHIAZIDE; LISINOPRIL AUROBINDO Labeling Approval
11/18/2015 RISPERIDONE
ANDA #078528		 SUPPL-9 RISPERIDONE SANDOZ Labeling Approval
11/18/2015 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-2 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
11/18/2015 MEMANTINE HYDROCHLORIDE
ANDA #090052		 SUPPL-2 MEMANTINE HYDROCHLORIDE TEVA PHARMS Labeling Approval
11/18/2015 ROPINIROLE HYDROCHLORIDE
ANDA #090429		 SUPPL-3 ROPINIROLE HYDROCHLORIDE ALEMBIC LTD Labeling Approval
11/18/2015 HALAVEN
NDA #201532		 SUPPL-14 ERIBULIN MESYLATE EISAI INC Manufacturing (CMC) Approval
11/18/2015 BLISOVI FE 1/20
ANDA #201584		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN LTD Approval
11/18/2015 BLISOVI FE 1.5/30
ANDA #201585		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE LUPIN LTD Approval
11/18/2015 EDARBYCLOR
NDA #202331		 SUPPL-8 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE AZURITY Manufacturing (CMC) Approval
11/18/2015 ZOLEDRONIC ACID
ANDA #202472		 SUPPL-4 ZOLEDRONIC ACID ACTAVIS INC Labeling Approval
11/18/2015 SILDENAFIL CITRATE
ANDA #203963		 ORIG-1 SILDENAFIL CITRATE AUROBINDO PHARMA LTD Approval
11/18/2015 RABEPRAZOLE SODIUM
ANDA #204237		 ORIG-1 RABEPRAZOLE SODIUM RUBICON Approval
11/18/2015 AMMONIA N 13
ANDA #204457		 ORIG-1 AMMONIA N-13 MIDWEST MEDCL Approval
11/18/2015 NARCAN
NDA #208411		 ORIG-1 NALOXONE HYDROCHLORIDE EMERGENT Type 3 - New Dosage Form Approval
11/19/2015 IMITREX
NDA #020080		 SUPPL-49 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
11/19/2015 IMITREX STATDOSE
NDA #020080		 SUPPL-49 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
11/19/2015 GONAL-F
BLA #020378		 SUPPL-43 FOLLITROPIN ALFA/BETA EMD SERONO Approval
11/19/2015 TWYNSTA
NDA #022401		 SUPPL-17 AMLODIPINE BESYLATE; TELMISARTAN BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
11/19/2015 ACANYA
NDA #050819		 SUPPL-14 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
11/19/2015 ONEXTON
NDA #050819		 SUPPL-14 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
11/19/2015 PROPOFOL
ANDA #075102		 SUPPL-32 PROPOFOL SAGENT PHARMS INC Labeling Approval
11/19/2015 SERTRALINE HYDROCHLORIDE
ANDA #076934		 SUPPL-6 SERTRALINE HYDROCHLORIDE ACI Labeling Approval
11/19/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565		 SUPPL-8 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/19/2015 ZIDOVUDINE
ANDA #078349		 SUPPL-18 ZIDOVUDINE CIPLA LTD Labeling Approval
11/19/2015 ALENDRONATE SODIUM
ANDA #079049		 SUPPL-4 ALENDRONATE SODIUM CHARTWELL RX Labeling Approval
11/19/2015 ALENDRONATE SODIUM
ANDA #079049		 SUPPL-5 ALENDRONATE SODIUM CHARTWELL RX Labeling Approval
11/19/2015 CARBIDOPA AND LEVODOPA
ANDA #090324		 SUPPL-4 CARBIDOPA; LEVODOPA MYLAN Labeling Approval
11/19/2015 CARBIDOPA AND LEVODOPA
ANDA #090324		 SUPPL-5 CARBIDOPA; LEVODOPA MYLAN Labeling Approval
11/19/2015 ATORVASTATIN CALCIUM
ANDA #091624		 SUPPL-2 ATORVASTATIN CALCIUM LANNETT CO INC Labeling Approval
11/19/2015 ATORVASTATIN CALCIUM
ANDA #091624		 SUPPL-3 ATORVASTATIN CALCIUM LANNETT CO INC Labeling Approval
11/19/2015 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200248		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL LUPIN LTD Approval
11/19/2015 FAMCICLOVIR
ANDA #201022		 SUPPL-6 FAMCICLOVIR MACLEODS PHARMS LTD Labeling Approval
11/19/2015 ZOLEDRONIC ACID
ANDA #202182		 SUPPL-1 ZOLEDRONIC ACID HIKMA FARMACEUTICA Labeling Approval
11/19/2015 PICATO
NDA #202833		 SUPPL-4 INGENOL MEBUTATE LEO LABS Efficacy Approval
11/19/2015 FLUDEOXYGLUCOSE F18
ANDA #203736		 ORIG-1 FLUDEOXYGLUCOSE F-18 MIDWEST MEDCL Approval
11/19/2015 SILDENAFIL CITRATE
ANDA #203988		 SUPPL-2 SILDENAFIL CITRATE EUGIA PHARMA Labeling Approval
11/20/2015 AZULFIDINE
NDA #007073		 SUPPL-127 SULFASALAZINE PFIZER Manufacturing (CMC) Approval
11/20/2015 AZULFIDINE EN-TABS
NDA #007073		 SUPPL-127 SULFASALAZINE PFIZER Manufacturing (CMC) Approval
11/20/2015 METHOTREXATE LPF
NDA #011719		 SUPPL-122 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/20/2015 METHOTREXATE PRESERVATIVE FREE
NDA #011719		 SUPPL-122 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/20/2015 METHOTREXATE SODIUM
NDA #011719		 SUPPL-122 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/20/2015 METHOTREXATE SODIUM PRESERVATIVE FREE
NDA #011719		 SUPPL-122 METHOTREXATE SODIUM HOSPIRA Labeling Approval
11/20/2015 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-31 DEXTROSE B BRAUN Manufacturing (CMC) Approval
11/20/2015 DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-31 DEXTROSE B BRAUN Manufacturing (CMC) Approval
11/20/2015 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-31 DEXTROSE B BRAUN Manufacturing (CMC) Approval
11/20/2015 DEXTROSE 7.7% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-31 DEXTROSE B BRAUN Manufacturing (CMC) Approval
11/20/2015 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-31 DEXTROSE B BRAUN Manufacturing (CMC) Approval
11/20/2015 TIAZAC
NDA #020401		 SUPPL-41 DILTIAZEM HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
11/20/2015 ZANTAC 75
NDA #020520		 SUPPL-30 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
11/20/2015 MIRAPEX
NDA #020667		 SUPPL-32 PRAMIPEXOLE DIHYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
11/20/2015 MONISTAT 3 COMBINATION PACK
NDA #020670		 SUPPL-28 MICONAZOLE NITRATE MEDTECH PRODUCTS Manufacturing (CMC) Approval
11/20/2015 CRESTOR
NDA #021366		 SUPPL-31 ROSUVASTATIN CALCIUM IPR Efficacy Approval
11/20/2015 ZANTAC 150
NDA #021698		 SUPPL-20 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
11/20/2015 ATRIPLA
NDA #021937		 SUPPL-37 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Labeling Approval
11/20/2015 CALDOLOR
NDA #022348		 SUPPL-5 IBUPROFEN CUMBERLAND PHARMS Efficacy Approval
11/20/2015 ELELYSO
BLA #022458		 SUPPL-7 TALIGLUCERASE ALFA PFIZER Approval
11/20/2015 PRADAXA
NDA #022512		 SUPPL-28 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Efficacy Approval
11/20/2015 THEOPHYLLINE
ANDA #040560		 SUPPL-6 THEOPHYLLINE NOSTRUM LABS INC Labeling Approval
11/20/2015 BENZPHETAMINE HYDROCHLORIDE
ANDA #040747		 SUPPL-6 BENZPHETAMINE HYDROCHLORIDE TEDOR PHARM Manufacturing (CMC) Approval
11/20/2015 TACROLIMUS
ANDA #065461		 SUPPL-25 TACROLIMUS SANDOZ Labeling Approval
11/20/2015 BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
ANDA #075231		 SUPPL-6 ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE LGM PHARMA Labeling Approval
11/20/2015 RIVASTIGMINE TARTRATE
ANDA #077129		 SUPPL-2 RIVASTIGMINE TARTRATE WATSON LABS Labeling Approval
11/20/2015 RIVASTIGMINE TARTRATE
ANDA #077129		 SUPPL-3 RIVASTIGMINE TARTRATE WATSON LABS Labeling Approval
11/20/2015 BUDESONIDE
ANDA #078949		 SUPPL-3 BUDESONIDE APOTEX INC Labeling Approval
11/20/2015 LOSARTAN POTASSIUM
ANDA #090382		 SUPPL-11 LOSARTAN POTASSIUM STRIDES PHARMA Labeling Approval
11/20/2015 HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
ANDA #091671		 SUPPL-5 CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX NEOS THERAPS INC Manufacturing (CMC) Approval
11/20/2015 Xeomin
BLA #125360		 SUPPL-66 incobotulinumtoxinA MERZ PHARMS Approval
11/20/2015 DONEPEZIL HYDROCHLORIDE
ANDA #200292		 SUPPL-3 DONEPEZIL HYDROCHLORIDE PRINSTON INC Labeling Approval
11/20/2015 DONEPEZIL HYDROCHLORIDE
ANDA #200292		 SUPPL-6 DONEPEZIL HYDROCHLORIDE PRINSTON INC Labeling Approval
11/20/2015 DUTASTERIDE
ANDA #200899		 ORIG-1 DUTASTERIDE CHARTWELL Approval
11/20/2015 VALSARTAN
ANDA #201677		 SUPPL-1 VALSARTAN LUPIN LTD Labeling Approval
11/20/2015 EPROSARTAN MESYLATE
ANDA #202012		 SUPPL-3 EPROSARTAN MESYLATE MYLAN PHARMS INC Labeling Approval
11/20/2015 EPROSARTAN MESYLATE
ANDA #202012		 SUPPL-4 EPROSARTAN MESYLATE MYLAN PHARMS INC Labeling Approval
11/20/2015 DUTASTERIDE
ANDA #202421		 ORIG-1 DUTASTERIDE VINTAGE Approval
11/20/2015 ACYCLOVIR
ANDA #202459		 SUPPL-3 ACYCLOVIR MYLAN PHARMS INC Manufacturing (CMC) Approval
11/20/2015 DUTASTERIDE
ANDA #202530		 ORIG-1 DUTASTERIDE RISING Approval
11/20/2015 DUTASTERIDE
ANDA #202660		 ORIG-1 DUTASTERIDE AUROBINDO PHARMA LTD Approval
11/20/2015 VALSARTAN
ANDA #202728		 SUPPL-3 VALSARTAN TORRENT Labeling Approval
11/20/2015 TAFINLAR
NDA #202806		 SUPPL-4 DABRAFENIB MESYLATE NOVARTIS Efficacy Approval
11/20/2015 DUTASTERIDE
ANDA #202808		 ORIG-1 DUTASTERIDE ACTAVIS LABS FL INC Approval
11/20/2015 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
ANDA #202975		 ORIG-1 DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE ACTAVIS LABS FL INC Approval
11/20/2015 DUTASTERIDE
ANDA #203118		 ORIG-1 DUTASTERIDE AMNEAL PHARMS Approval
11/20/2015 MEKINIST
NDA #204114		 SUPPL-4 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Efficacy Approval
11/20/2015 DUTASTERIDE
ANDA #204262		 ORIG-1 DUTASTERIDE STRIDES PHARMA Approval
11/20/2015 DUTASTERIDE
ANDA #204705		 ORIG-1 DUTASTERIDE NOSTRUM LABS INC Approval
11/20/2015 VARITHENA
NDA #205098		 SUPPL-12 POLIDOCANOL PROVENSIS Manufacturing (CMC) Approval
11/20/2015 LONSURF
NDA #207981		 SUPPL-2 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Manufacturing (CMC) Approval
11/20/2015 NINLARO
NDA #208462		 ORIG-1 IXAZOMIB CITRATE TAKEDA PHARMS USA Type 1 - New Molecular Entity Approval
11/23/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #020178		 SUPPL-13 SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
11/23/2015 DEFINITY
NDA #021064		 SUPPL-18 PERFLUTREN LANTHEUS MEDCL Manufacturing (CMC) Approval
11/23/2015 DEFINITY RT
NDA #021064		 SUPPL-18 PERFLUTREN LANTHEUS MEDCL Manufacturing (CMC) Approval
11/23/2015 FORTEO
NDA #021318		 SUPPL-44 TERIPARATIDE LILLY Manufacturing (CMC) Approval
11/23/2015 RIFAMPIN
ANDA #065028		 SUPPL-15 RIFAMPIN HIKMA Labeling Approval
11/23/2015 SUMATRIPTAN SUCCINATE
ANDA #076554		 SUPPL-4 SUMATRIPTAN SUCCINATE SUN PHARM INDS LTD Labeling Approval
11/23/2015 SUMATRIPTAN SUCCINATE
ANDA #076572		 SUPPL-4 SUMATRIPTAN SUCCINATE SUN PHARM INDS LTD Labeling Approval
11/23/2015 TEMOZOLOMIDE
ANDA #078879		 SUPPL-11 TEMOZOLOMIDE HERITAGE Labeling Approval
11/23/2015 TEMOZOLOMIDE
ANDA #078879		 SUPPL-12 TEMOZOLOMIDE HERITAGE Labeling Approval
11/23/2015 TEMOZOLOMIDE
ANDA #078879		 SUPPL-13 TEMOZOLOMIDE HERITAGE Labeling Approval
11/23/2015 RANITIDINE HYDROCHLORIDE
ANDA #079211		 SUPPL-2 RANITIDINE HYDROCHLORIDE WOCKHARDT Labeling Approval
11/23/2015 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
ANDA #088400		 SUPPL-30 STERILE WATER FOR INJECTION FRESENIUS KABI USA Labeling Approval
11/23/2015 EFAVIRENZ
ANDA #091175		 ORIG-1 EFAVIRENZ TEVA PHARMS USA Tentative Approval
11/23/2015 HUMIRA
BLA #125057		 SUPPL-394 ADALIMUMAB ABBVIE INC Approval
11/23/2015 OPDIVO
BLA #125554		 SUPPL-1 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
11/23/2015 OPDIVO
BLA #125554		 SUPPL-12 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
11/23/2015 DUTASTERIDE
ANDA #202204		 ORIG-1 DUTASTERIDE HIKMA Approval
11/23/2015 LINZESS
NDA #202811		 SUPPL-9 LINACLOTIDE ABBVIE Labeling Approval
11/23/2015 DEXTROAMPHETAMINE SULFATE
ANDA #203548		 ORIG-1 DEXTROAMPHETAMINE SULFATE AVANTHI INC Approval
11/23/2015 OXYBUTYNIN CHLORIDE
ANDA #204010		 ORIG-1 OXYBUTYNIN CHLORIDE AMNEAL PHARMS Approval
11/23/2015 CLOBETASOL PROPIONATE
ANDA #206075		 ORIG-1 CLOBETASOL PROPIONATE NOVEL LABS INC Approval
11/23/2015 NEXIUM 24HR
NDA #207920		 ORIG-1 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Type 3 - New Dosage Form Approval
11/24/2015 PROZAC
NDA #018936		 SUPPL-106 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
11/24/2015 SARAFEM
NDA #018936		 SUPPL-106 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
11/24/2015 FIRAZYR
NDA #022150		 SUPPL-7 ICATIBANT ACETATE TAKEDA PHARMS USA Labeling Approval
11/24/2015 XERESE
NDA #022436		 SUPPL-5 ACYCLOVIR; HYDROCORTISONE BAUSCH Manufacturing (CMC) Approval
11/24/2015 DALIRESP
NDA #022522		 SUPPL-6 ROFLUMILAST ASTRAZENECA Labeling Approval
11/24/2015 AMPICILLIN AND SULBACTAM
ANDA #065403		 SUPPL-7 AMPICILLIN SODIUM; SULBACTAM SODIUM ACS DOBFAR Labeling Approval
11/24/2015 AMPICILLIN AND SULBACTAM
ANDA #065403		 SUPPL-8 AMPICILLIN SODIUM; SULBACTAM SODIUM ACS DOBFAR Labeling Approval
11/24/2015 GALANTAMINE HYDROBROMIDE
ANDA #077608		 SUPPL-1 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
11/24/2015 GALANTAMINE HYDROBROMIDE
ANDA #077608		 SUPPL-2 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
11/24/2015 AMLODIPINE BESYLATE
ANDA #078477		 SUPPL-18 AMLODIPINE BESYLATE AMNEAL PHARMS NY Labeling Approval
11/24/2015 GALANTAMINE HYDROBROMIDE
ANDA #078898		 SUPPL-2 GALANTAMINE HYDROBROMIDE ZYDUS PHARMS USA INC Labeling Approval
11/24/2015 GALANTAMINE HYDROBROMIDE
ANDA #078898		 SUPPL-5 GALANTAMINE HYDROBROMIDE ZYDUS PHARMS USA INC Labeling Approval
11/24/2015 AMLODIPINE BESYLATE
ANDA #078925		 SUPPL-7 AMLODIPINE BESYLATE ALKEM Labeling Approval
11/24/2015 LEVETIRACETAM
ANDA #090906		 SUPPL-6 LEVETIRACETAM LOTUS PHARM CO LTD Labeling Approval
11/24/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091264		 SUPPL-3 LEVOCETIRIZINE DIHYDROCHLORIDE HETERO LABS LTD III Labeling Approval
11/24/2015 PORTRAZZA
BLA #125547		 ORIG-1 NECITUMUMAB ELI LILLY CO Approval
11/24/2015 QUETIAPINE FUMARATE
ANDA #200363		 SUPPL-3 QUETIAPINE FUMARATE TORRENT PHARMS LTD Labeling Approval
11/24/2015 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #201356		 SUPPL-5 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
11/24/2015 QUINAPRIL HYDROCHLORIDE
ANDA #202725		 SUPPL-5 QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/24/2015 QUINAPRIL HYDROCHLORIDE
ANDA #202725		 SUPPL-6 QUINAPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/24/2015 NIFEDIPINE
ANDA #203126		 SUPPL-1 NIFEDIPINE TWI PHARMS Labeling Approval
11/24/2015 NIFEDIPINE
ANDA #203126		 SUPPL-2 NIFEDIPINE TWI PHARMS Labeling Approval
11/24/2015 KALYDECO
NDA #203188		 SUPPL-9 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
11/24/2015 DUTASTERIDE
ANDA #204292		 ORIG-1 DUTASTERIDE APOTEX Approval
11/24/2015 MESALAMINE
ANDA #204354		 ORIG-1 MESALAMINE MYLAN Approval
11/25/2015 BICNU
NDA #017422		 SUPPL-49 CARMUSTINE AVET LIFESCIENCES Manufacturing (CMC) Approval
11/25/2015 CLARITIN-D
NDA #019670		 SUPPL-32 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Labeling Approval
11/25/2015 CLARITIN-D 24 HOUR
NDA #020470		 SUPPL-44 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Labeling Approval
11/25/2015 CLARITIN HIVES RELIEF REDITAB
NDA #020704		 SUPPL-28 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
11/25/2015 CLARITIN REDITABS
NDA #020704		 SUPPL-28 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
11/25/2015 TIKOSYN
NDA #020931		 SUPPL-10 DOFETILIDE PFIZER REMS Approval
11/25/2015 SYNTHROID
NDA #021402		 SUPPL-29 LEVOTHYROXINE SODIUM ABBVIE Manufacturing (CMC) Approval
11/25/2015 CLARITIN REDITABS
NDA #021993		 SUPPL-13 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
11/25/2015 POTIGA
NDA #022345		 SUPPL-9 EZOGABINE GLAXOSMITHKLINE REMS Approval
11/25/2015 ONGLYZA
NDA #022350		 SUPPL-17 SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Manufacturing (CMC) Approval
11/25/2015 RIFAMPIN
ANDA #065502		 SUPPL-2 RIFAMPIN EPIC PHARMA LLC Labeling Approval
11/25/2015 LABETALOL HYDROCHLORIDE
ANDA #075113		 SUPPL-28 LABETALOL HYDROCHLORIDE SANDOZ Labeling Approval
11/25/2015 LISINOPRIL
ANDA #075944		 SUPPL-27 LISINOPRIL SUN PHARM INDS LTD Labeling Approval
11/25/2015 QUINAPRIL HYDROCHLORIDE
ANDA #076607		 SUPPL-13 QUINAPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
11/25/2015 OXCARBAZEPINE
ANDA #077795		 SUPPL-9 OXCARBAZEPINE HIKMA Labeling Approval
11/25/2015 RANITIDINE HYDROCHLORIDE
ANDA #078192		 SUPPL-14 RANITIDINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
11/25/2015 QUINAPRIL HYDROCHLORIDE
ANDA #078457		 SUPPL-5 QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
11/25/2015 QUINAPRIL HYDROCHLORIDE
ANDA #078457		 SUPPL-6 QUINAPRIL HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
11/25/2015 TELMISARTAN
ANDA #078710		 SUPPL-1 TELMISARTAN CHARTWELL RX Labeling Approval
11/25/2015 TELMISARTAN
ANDA #078710		 SUPPL-2 TELMISARTAN CHARTWELL RX Labeling Approval
11/25/2015 CLOZAPINE
ANDA #090308		 ORIG-1 CLOZAPINE BARR LABS INC Approval
11/25/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090385		 SUPPL-4 LEVOCETIRIZINE DIHYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
11/25/2015 GADAVIST
NDA #201277		 SUPPL-12 GADOBUTROL BAYER HLTHCARE Manufacturing (CMC) Approval
11/25/2015 MORPHINE SULFATE
ANDA #202309		 ORIG-1 MORPHINE SULFATE CHARTWELL MOLECULAR Approval
11/25/2015 CLOZAPINE
ANDA #202873		 ORIG-1 CLOZAPINE ACCORD HLTHCARE Approval
11/25/2015 CLOZAPINE
ANDA #203039		 ORIG-1 CLOZAPINE TEVA PHARMS USA Approval
11/25/2015 TYBOST
NDA #203094		 SUPPL-3 COBICISTAT GILEAD SCIENCES INC Efficacy Approval
11/25/2015 FLONASE ALLERGY RELIEF
NDA #205434		 SUPPL-3 FLUTICASONE PROPIONATE HALEON US HOLDINGS Labeling Approval
11/25/2015 IMBRUVICA
NDA #205552		 SUPPL-9 IBRUTINIB PHARMACYCLICS LLC Manufacturing (CMC) Approval
11/25/2015 HUMALOG KWIKPEN
BLA #205747		 SUPPL-1 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
11/27/2015 BACTRIM
NDA #017377		 SUPPL-77 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
11/27/2015 BACTRIM DS
NDA #017377		 SUPPL-77 SULFAMETHOXAZOLE; TRIMETHOPRIM SUN PHARM INDUSTRIES Manufacturing (CMC) Approval
11/27/2015 FIBRICOR
NDA #022418		 SUPPL-13 FENOFIBRIC ACID ATHENA Manufacturing (CMC) Approval
11/27/2015 RIZATRIPTAN BENZOATE
ANDA #077526		 SUPPL-1 RIZATRIPTAN BENZOATE CHARTWELL RX Manufacturing (CMC) Approval
11/27/2015 DORZOLAMIDE HYDROCHLORIDE
ANDA #078395		 SUPPL-8 DORZOLAMIDE HYDROCHLORIDE RUBICON Labeling Approval
11/27/2015 AMPICILLIN SODIUM
ANDA #090583		 ORIG-1 AMPICILLIN SODIUM SAGENT PHARMS INC Approval
11/27/2015 ISRADIPINE
ANDA #201067		 ORIG-1 ISRADIPINE MYLAN Approval
11/27/2015 GEMCITABINE HYDROCHLORIDE
ANDA #202063		 SUPPL-1 GEMCITABINE HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
11/27/2015 GEMCITABINE HYDROCHLORIDE
ANDA #202063		 SUPPL-3 GEMCITABINE HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
11/27/2015 GEMCITABINE HYDROCHLORIDE
ANDA #202063		 SUPPL-4 GEMCITABINE HYDROCHLORIDE EMCURE PHARMS LTD Labeling Approval
11/27/2015 OLANZAPINE
ANDA #203044		 SUPPL-1 OLANZAPINE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
11/27/2015 OLANZAPINE
ANDA #203044		 SUPPL-3 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/27/2015 NEBIVOLOL HYDROCHLORIDE
ANDA #203683		 ORIG-1 NEBIVOLOL HYDROCHLORIDE WATSON LABS INC Approval
11/27/2015 OMEGA-3-ACID ETHYL ESTERS
ANDA #204940		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS AMNEAL PHARMS Approval
11/27/2015 PAROXETINE HYDROCHLORIDE
ANDA #205528		 ORIG-1 PAROXETINE HYDROCHLORIDE JUBILANT GENERICS Approval
11/27/2015 PATADAY ONCE DAILY RELIEF
NDA #206276		 SUPPL-1 OLOPATADINE HYDROCHLORIDE ALCON LABS INC Manufacturing (CMC) Approval
11/30/2015 DESOGEN
NDA #020071		 SUPPL-22 DESOGESTREL; ETHINYL ESTRADIOL ORGANON USA INC Manufacturing (CMC) Approval
11/30/2015 FOSAMAX
NDA #020560		 SUPPL-69 ALENDRONATE SODIUM ORGANON Labeling Approval
11/30/2015 FOSAMAX
NDA #021575		 SUPPL-25 ALENDRONATE SODIUM MERCK Labeling Approval
11/30/2015 VITRASE
BLA #021640		 SUPPL-23 HYALURONIDASE BAUSCH AND LOMB Approval
11/30/2015 FOSAMAX PLUS D
NDA #021762		 SUPPL-21 ALENDRONATE SODIUM; CHOLECALCIFEROL ORGANON LLC Labeling Approval
11/30/2015 VALPROIC ACID
ANDA #073484		 SUPPL-26 VALPROIC ACID BIONPHARMA Labeling Approval
11/30/2015 VALPROIC ACID
ANDA #073484		 SUPPL-27 VALPROIC ACID BIONPHARMA Labeling Approval
11/30/2015 VALPROIC ACID
ANDA #073484		 SUPPL-28 VALPROIC ACID BIONPHARMA Labeling Approval
11/30/2015 VALPROIC ACID
ANDA #073484		 SUPPL-30 VALPROIC ACID BIONPHARMA Labeling Approval
11/30/2015 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074694		 SUPPL-6 CLOMIPRAMINE HYDROCHLORIDE TARO Labeling Approval
11/30/2015 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074694		 SUPPL-8 CLOMIPRAMINE HYDROCHLORIDE TARO Labeling Approval
11/30/2015 PRAVASTATIN SODIUM
ANDA #076056		 SUPPL-14 PRAVASTATIN SODIUM TEVA Labeling Approval
11/30/2015 ISOSORBIDE MONONITRATE
ANDA #076813		 SUPPL-12 ISOSORBIDE MONONITRATE HIKMA INTL PHARMS Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-17 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-20 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078014		 SUPPL-2 ONDANSETRON HYDROCHLORIDE TARO PHARMS IRELAND Labeling Approval
11/30/2015 ONDANSETRON HYDROCHLORIDE
ANDA #078180		 SUPPL-1 ONDANSETRON HYDROCHLORIDE SAGENT PHARMS Labeling Approval
11/30/2015 BUDESONIDE
ANDA #078202		 SUPPL-5 BUDESONIDE NEPHRON Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-11 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-12 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-14 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-15 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #078239		 SUPPL-17 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 METOCLOPRAMIDE HYDROCHLORIDE
ANDA #078374		 SUPPL-8 METOCLOPRAMIDE HYDROCHLORIDE NORTHSTAR HLTHCARE Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #078919		 SUPPL-16 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
11/30/2015 TOPIRAMATE
ANDA #079153		 SUPPL-17 TOPIRAMATE TORRENT PHARMS Labeling Approval
11/30/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090056		 SUPPL-8 DONEPEZIL HYDROCHLORIDE AUROBINDO Labeling Approval
11/30/2015 FELODIPINE
ANDA #090365		 SUPPL-3 FELODIPINE GLENMARK PHARMS LTD Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-10 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-11 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-14 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/30/2015 DIVALPROEX SODIUM
ANDA #090554		 SUPPL-16 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
11/30/2015 RISEDRONATE SODIUM
ANDA #090877		 ORIG-2 RISEDRONATE SODIUM APOTEX Approval
11/30/2015 RISEDRONATE SODIUM
ANDA #090886		 ORIG-2 RISEDRONATE SODIUM SUN PHARM Approval
11/30/2015 LOPERAMIDE HYDROCHLORIDE
ANDA #091292		 SUPPL-3 LOPERAMIDE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
11/30/2015 LOPERAMIDE HYDROCHLORIDE
ANDA #091292		 SUPPL-8 LOPERAMIDE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
11/30/2015 RISEDRONATE SODIUM
ANDA #200296		 ORIG-1 RISEDRONATE SODIUM AUROBINDO PHARMA LTD Approval
11/30/2015 RISEDRONATE SODIUM
ANDA #200477		 ORIG-2 RISEDRONATE SODIUM MYLAN Approval
11/30/2015 TELMISARTAN AND AMLODIPINE
ANDA #202517		 SUPPL-3 AMLODIPINE BESYLATE; TELMISARTAN TORRENT Labeling Approval
11/30/2015 PARICALCITOL
ANDA #202539		 SUPPL-1 PARICALCITOL BIONPHARMA Labeling Approval
11/30/2015 MEMANTINE HYDROCHLORIDE
ANDA #206528		 ORIG-1 MEMANTINE HYDROCHLORIDE AJANTA PHARMA LTD Approval
11/30/2015 EMPLICITI
BLA #761035		 ORIG-1 ELOTUZUMAB BRISTOL MYERS SQUIBB Approval
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