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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
October 2014

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 October 07, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
10/01/2014 FUROSEMIDE
NDA #018415		 SUPPL-26 FUROSEMIDE ESJAY PHARMA Labeling Approval
10/01/2014 MIRCERA
BLA #125164		 SUPPL-62 METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA HOFFMAN-LA ROCHE Approval
10/02/2014 PITOCIN
NDA #018261		 SUPPL-31 OXYTOCIN PH HEALTH Labeling Approval
10/02/2014 NITROGLYCERIN IN DEXTROSE 5%
NDA #019970		 SUPPL-15 NITROGLYCERIN BAXTER HLTHCARE Labeling Approval
10/02/2014 NITRO-DUR
NDA #020145		 SUPPL-27 NITROGLYCERIN USPHARMA Labeling Approval
10/02/2014 MONOKET
NDA #020215		 SUPPL-24 ISOSORBIDE MONONITRATE OMNIVIUM PHARMS Labeling Approval
10/02/2014 ADENOSINE
ANDA #090450		 ORIG-1 ADENOSINE RISING Approval
10/03/2014 CORTIFOAM
NDA #017351		 SUPPL-37 HYDROCORTISONE ACETATE VIATRIS Manufacturing (CMC) Approval
10/03/2014 FLO-PRED
NDA #022067		 SUPPL-12 PREDNISOLONE ACETATE SUN PHARMA CANADA Manufacturing (CMC) Approval
10/03/2014 NEXIUM 24HR
NDA #204655		 SUPPL-1 ESOMEPRAZOLE MAGNESIUM ASTRAZENECA LP Labeling Approval
10/06/2014 EYLEA
BLA #125387		 SUPPL-43 AFLIBERCEPT REGENERON PHARMACEUTICALS Approval
10/06/2014 CALCIUM ACETATE
ANDA #201658		 ORIG-1 CALCIUM ACETATE AMNEAL PHARMS Approval
10/06/2014 ORENITRAM
NDA #203496		 SUPPL-1 TREPROSTINIL DIOLAMINE UNITED THERAP Manufacturing (CMC) Approval
10/07/2014 ZOLADEX
NDA #019726		 SUPPL-58 GOSERELIN ACETATE TERSERA Labeling Approval
10/07/2014 AMBIEN
NDA #019908		 SUPPL-35 ZOLPIDEM TARTRATE COSETTE Labeling Approval
10/07/2014 ZOLADEX
NDA #020578		 SUPPL-36 GOSERELIN ACETATE TERSERA Labeling Approval
10/07/2014 BENICAR
NDA #021286		 SUPPL-28 OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
10/07/2014 AMBIEN CR
NDA #021774		 SUPPL-16 ZOLPIDEM TARTRATE COSETTE Labeling Approval
10/07/2014 TORISEL
NDA #022088		 SUPPL-17 TEMSIROLIMUS PF PRISM CV Labeling Approval
10/07/2014 LO MINASTRIN FE
NDA #204654		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
10/07/2014 OTREXUP
NDA #204824		 SUPPL-1 METHOTREXATE COSETTE Manufacturing (CMC) Approval
10/07/2014 OTREXUP PFS
NDA #204824		 SUPPL-1 METHOTREXATE COSETTE Manufacturing (CMC) Approval
10/07/2014 UCERIS
NDA #205613		 ORIG-1 BUDESONIDE SALIX Type 3 - New Dosage Form Approval
10/08/2014 EURAX
NDA #009112		 SUPPL-25 CROTAMITON JOURNEY Manufacturing (CMC) Approval
10/08/2014 TAMIFLU
NDA #021087		 SUPPL-66 OSELTAMIVIR PHOSPHATE ROCHE Manufacturing (CMC) Approval
10/08/2014 VELCADE
NDA #021602		 SUPPL-40 BORTEZOMIB TAKEDA PHARMS USA Efficacy Approval
10/08/2014 OLOPATADINE HYDROCHLORIDE
ANDA #091572		 ORIG-1 OLOPATADINE HYDROCHLORIDE APOTEX INC Approval
10/08/2014 OTREXUP
NDA #204824		 SUPPL-2 METHOTREXATE COSETTE Manufacturing (CMC) Approval
10/08/2014 OTREXUP PFS
NDA #204824		 SUPPL-2 METHOTREXATE COSETTE Manufacturing (CMC) Approval
10/09/2014 VERELAN
NDA #019614		 SUPPL-50 VERAPAMIL HYDROCHLORIDE AZURITY Labeling Approval
10/09/2014 DOXYLAMINE SUCCINATE
ANDA #040167		 SUPPL-41 DOXYLAMINE SUCCINATE PERRIGO Manufacturing (CMC) Approval
10/09/2014 LEVOTHYROXINE SODIUM
ANDA #076187		 SUPPL-28 LEVOTHYROXINE SODIUM MYLAN Manufacturing (CMC) Approval
10/09/2014 COLESTIPOL HYDROCHLORIDE
ANDA #077510		 SUPPL-8 COLESTIPOL HYDROCHLORIDE IMPAX LABS Manufacturing (CMC) Approval
10/09/2014 PEGINTRON
BLA #103949		 SUPPL-5296 PEGINTERFERON ALFA-2B SCHERING Approval
10/09/2014 SYLATRON
BLA #103949		 SUPPL-5296 PEGINTERFERON ALFA-2B SCHERING Approval
10/10/2014 PROZAC
NDA #018936		 SUPPL-102 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Efficacy Approval
10/10/2014 SARAFEM
NDA #018936		 SUPPL-102 FLUOXETINE HYDROCHLORIDE ELI LILLY AND CO Efficacy Approval
10/10/2014 NAFTIN
NDA #019599		 SUPPL-12 NAFTIFINE HYDROCHLORIDE LEGACY Efficacy Approval
10/10/2014 CUROSURF
BLA #020744		 SUPPL-28 PORACTANT ALFA CHIESI USA INC Approval
10/10/2014 ELIGARD KIT
NDA #021343		 SUPPL-30 LEUPROLIDE ACETATE TOLMAR Labeling Approval
10/10/2014 ELIGARD KIT
NDA #021343		 SUPPL-31 LEUPROLIDE ACETATE TOLMAR Manufacturing (CMC) Approval
10/10/2014 ELIGARD KIT
NDA #021379		 SUPPL-30 LEUPROLIDE ACETATE TOLMAR Labeling Approval
10/10/2014 ELIGARD KIT
NDA #021488		 SUPPL-27 LEUPROLIDE ACETATE TOLMAR Labeling Approval
10/10/2014 SYMBYAX
NDA #021520		 SUPPL-41 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Efficacy Approval
10/10/2014 ELIGARD KIT
NDA #021731		 SUPPL-27 LEUPROLIDE ACETATE TOLMAR Labeling Approval
10/10/2014 ISENTRESS
NDA #022145		 SUPPL-33 RALTEGRAVIR POTASSIUM MSD SUB MERCK Manufacturing (CMC) Approval
10/10/2014 ISENTRESS HD
NDA #022145		 SUPPL-33 RALTEGRAVIR POTASSIUM MSD SUB MERCK Manufacturing (CMC) Approval
10/10/2014 SOLIRIS
BLA #125166		 SUPPL-409 ECULIZUMAB ALEXION PHARM Approval
10/10/2014 LUMASON
NDA #203684		 ORIG-1 SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES BRACCO Type 1 - New Molecular Entity Approval
10/10/2014 NAFTIN
NDA #204286		 SUPPL-1 NAFTIFINE HYDROCHLORIDE LEGACY Efficacy Approval
10/10/2014 AKYNZEO
NDA #205718		 ORIG-1 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Type 1 - New Molecular Entity and Type 4 - New Combination Approval
10/10/2014 HARVONI
NDA #205834		 ORIG-1 LEDIPASVIR; SOFOSBUVIR GILEAD SCIENCES INC Type 1 - New Molecular Entity and Type 4 - New Combination Approval
10/13/2014 ADRENACLICK
NDA #020800		 SUPPL-29 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
10/13/2014 TWINJECT
NDA #020800		 SUPPL-29 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
10/13/2014 OXYCONTIN
NDA #022272		 SUPPL-25 OXYCODONE HYDROCHLORIDE KNOA PHARMA Manufacturing (CMC) Approval
10/13/2014 VALCHLOR
NDA #202317		 SUPPL-3 MECHLORETHAMINE HYDROCHLORIDE HELSINN Manufacturing (CMC) Approval
10/14/2014 DRYTEC
NDA #017693		 SUPPL-26 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR GE HEALTHCARE Labeling Approval
10/14/2014 VERELAN PM
NDA #020943		 SUPPL-29 VERAPAMIL HYDROCHLORIDE AZURITY Labeling Approval
10/14/2014 TAMIFLU
NDA #021087		 SUPPL-65 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
10/14/2014 TAMIFLU
NDA #021246		 SUPPL-48 OSELTAMIVIR PHOSPHATE ROCHE Labeling Approval
10/14/2014 RIMANTADINE HYDROCHLORIDE
ANDA #076132		 SUPPL-8 RIMANTADINE HYDROCHLORIDE IMPAX LABS Manufacturing (CMC) Approval
10/14/2014 EPLERENONE
ANDA #078510		 SUPPL-11 EPLERENONE SANDOZ Manufacturing (CMC) Approval
10/14/2014 LYMPHOSEEK KIT
NDA #202207		 SUPPL-2 TECHNETIUM TC-99M TILMANOCEPT CARDINAL HEALTH 414 Efficacy Approval
10/15/2014 CUROSURF
BLA #020744		 SUPPL-29 PORACTANT ALFA CHIESI USA INC Approval
10/15/2014 ACIPHEX
NDA #020973		 SUPPL-34 RABEPRAZOLE SODIUM WAYLIS THERAP Labeling Approval
10/15/2014 CHANTIX
NDA #021928		 SUPPL-33 VARENICLINE TARTRATE PF PRISM CV Efficacy Approval
10/15/2014 CHANTIX
NDA #021928		 SUPPL-34 VARENICLINE TARTRATE PF PRISM CV Efficacy Approval
10/15/2014 CHANTIX
NDA #021928		 SUPPL-37 VARENICLINE TARTRATE PF PRISM CV Labeling Approval
10/15/2014 ISTODAX
NDA #022393		 SUPPL-13 ROMIDEPSIN BRISTOL-MYERS Efficacy Approval
10/15/2014 ESBRIET
NDA #022535		 ORIG-1 PIRFENIDONE LEGACY Type 1 - New Molecular Entity Approval
10/15/2014 LINCOCIN
NDA #050317		 SUPPL-177 LINCOMYCIN HYDROCHLORIDE PFIZER Labeling Approval
10/15/2014 DUAC
NDA #050741		 SUPPL-23 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE STIEFEL Manufacturing (CMC) Approval
10/15/2014 METHYLPHENIDATE HYDROCHLORIDE
ANDA #079031		 ORIG-2 METHYLPHENIDATE HYDROCHLORIDE BARR LABS INC Approval
10/15/2014 DICLOFENAC SODIUM
ANDA #090066		 SUPPL-1 DICLOFENAC SODIUM UNIQUE Manufacturing (CMC) Approval
10/15/2014 MARQIBO KIT
NDA #202497		 SUPPL-2 VINCRISTINE SULFATE ACROTECH Manufacturing (CMC) Approval
10/15/2014 ERIVEDGE
NDA #203388		 SUPPL-4 VISMODEGIB GENENTECH Manufacturing (CMC) Approval
10/15/2014 NEURACEQ
NDA #204677		 SUPPL-2 FLORBETABEN F-18 LANTHEUS Manufacturing (CMC) Approval
10/15/2014 NEURACEQ
NDA #204677		 SUPPL-3 FLORBETABEN F-18 LANTHEUS Manufacturing (CMC) Approval
10/15/2014 ACIPHEX SPRINKLE
NDA #204736		 SUPPL-4 RABEPRAZOLE SODIUM AYTU Labeling Approval
10/15/2014 OFEV
NDA #205832		 ORIG-1 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Type 1 - New Molecular Entity Approval
10/16/2014 FIORINAL
NDA #017534		 SUPPL-73 ASPIRIN; BUTALBITAL; CAFFEINE ALLERGAN Manufacturing (CMC) Approval
10/16/2014 INDOCIN
NDA #018332		 SUPPL-36 INDOMETHACIN COSETTE Manufacturing (CMC) Approval
10/16/2014 XELODA
NDA #020896		 SUPPL-34 CAPECITABINE CHEPLAPHARM Labeling Approval
10/16/2014 CYMBALTA
NDA #021427		 SUPPL-43 DULOXETINE HYDROCHLORIDE LILLY Efficacy Approval
10/16/2014 CYMBALTA
NDA #021427		 SUPPL-44 DULOXETINE HYDROCHLORIDE LILLY Efficacy Approval
10/16/2014 MEGACE ES
NDA #021778		 SUPPL-19 MEGESTROL ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
10/16/2014 MEGACE ES
NDA #021778		 SUPPL-20 MEGESTROL ACETATE ENDO OPERATIONS Manufacturing (CMC) Approval
10/16/2014 HYLENEX RECOMBINANT
BLA #021859		 SUPPL-19 HYALURONIDASE RECOMBINANT HUMAN HALOZYME THERAP Approval
10/16/2014 LIALDA
NDA #022000		 SUPPL-13 MESALAMINE TAKEDA PHARMS USA Labeling Approval
10/16/2014 PRAVASTATIN SODIUM
ANDA #077987		 SUPPL-10 PRAVASTATIN SODIUM GLENMARK PHARMS LTD Labeling Approval
10/16/2014 TERBINAFINE HYDROCHLORIDE
ANDA #078157		 SUPPL-4 TERBINAFINE HYDROCHLORIDE GLENMARK PHARMS LTD Manufacturing (CMC) Approval
10/16/2014 ILARIS
BLA #125319		 SUPPL-81 CANAKINUMAB NOVARTIS PHARMS Approval
10/16/2014 VASCEPA
NDA #202057		 SUPPL-11 ICOSAPENT ETHYL AMARIN PHARMS Manufacturing (CMC) Approval
10/16/2014 ARGATROBAN
NDA #203049		 SUPPL-3 ARGATROBAN HIKMA PHARM CO LTD Manufacturing (CMC) Approval
10/17/2014 DYNA-HEX 4
NDA #019125		 SUPPL-42 CHLORHEXIDINE GLUCONATE XTTRIUM Labeling Approval
10/17/2014 ADRENACLICK
NDA #020800		 SUPPL-30 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
10/17/2014 TWINJECT
NDA #020800		 SUPPL-30 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
10/17/2014 COMBIVENT RESPIMAT
NDA #021747		 SUPPL-5 ALBUTEROL SULFATE; IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Labeling Approval
10/17/2014 EMBEDA
NDA #022321		 SUPPL-16 MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE ALPHARMA PHARMS Efficacy Approval
10/17/2014 FLUOXETINE HYDROCHLORIDE
ANDA #076001		 SUPPL-35 FLUOXETINE HYDROCHLORIDE TEVA PHARMS USA Manufacturing (CMC) Approval
10/17/2014 GRANISETRON HYDROCHLORIDE
ANDA #078258		 SUPPL-1 GRANISETRON HYDROCHLORIDE AMNEAL Labeling Approval
10/17/2014 GRANISETRON HYDROCHLORIDE
ANDA #078969		 SUPPL-3 GRANISETRON HYDROCHLORIDE NATCO PHARMA Labeling Approval
10/17/2014 PARICALCITOL
ANDA #091108		 SUPPL-1 PARICALCITOL SANDOZ Manufacturing (CMC) Approval
10/17/2014 AUBAGIO
NDA #202992		 SUPPL-1 TERIFLUNOMIDE SANOFI AVENTIS US Efficacy Approval
10/17/2014 SIRTURO
NDA #204384		 SUPPL-4 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
10/20/2014 FLOMAX
NDA #020579		 SUPPL-29 TAMSULOSIN HYDROCHLORIDE SANOFI Labeling Approval
10/20/2014 TARKA
NDA #020591		 SUPPL-22 TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
10/20/2014 NEXIUM IV
NDA #021689		 SUPPL-29 ESOMEPRAZOLE SODIUM ASTRAZENECA Manufacturing (CMC) Approval
10/20/2014 BONIVA
NDA #021858		 SUPPL-16 IBANDRONATE SODIUM ROCHE Manufacturing (CMC) Approval
10/20/2014 ABSORICA
NDA #021951		 SUPPL-4 ISOTRETINOIN SUN PHARM INDS INC Manufacturing (CMC) Approval
10/20/2014 DUTOPROL
NDA #021956		 SUPPL-4 HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE CONCORDIA Labeling Approval
10/20/2014 AFINITOR
NDA #022334		 SUPPL-28 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
10/20/2014 CLEOCIN PHOSPHATE
NDA #050441		 SUPPL-70 CLINDAMYCIN PHOSPHATE PFIZER Manufacturing (CMC) Approval
10/20/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065205		 SUPPL-13 AMOXICILLIN; CLAVULANATE POTASSIUM CHARTWELL RX Manufacturing (CMC) Approval
10/20/2014 BUMETANIDE
ANDA #074700		 SUPPL-19 BUMETANIDE SANDOZ Manufacturing (CMC) Approval
10/20/2014 MODAFINIL
ANDA #076594		 SUPPL-1 MODAFINIL NATCO PHARMA Manufacturing (CMC) Approval
10/20/2014 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #091397		 SUPPL-3 LEVOFLOXACIN BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
10/20/2014 XIAFLEX
BLA #125338		 SUPPL-84 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
10/21/2014 TOPAMAX
NDA #020505		 SUPPL-54 TOPIRAMATE JANSSEN PHARMS Labeling Approval
10/21/2014 EFFEXOR XR
NDA #020699		 SUPPL-104 VENLAFAXINE HYDROCHLORIDE UPJOHN Labeling Approval
10/21/2014 TOPAMAX
NDA #020844		 SUPPL-45 TOPIRAMATE JANSSEN PHARMS Labeling Approval
10/21/2014 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-45 TOPIRAMATE JANSSEN PHARMS Labeling Approval
10/21/2014 SAPHRIS
NDA #022117		 SUPPL-11 ASENAPINE MALEATE ABBVIE Labeling Approval
10/21/2014 MINOCYCLINE HYDROCHLORIDE
ANDA #065436		 SUPPL-2 MINOCYCLINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
10/21/2014 FLUOXETINE HYDROCHLORIDE
ANDA #075465		 SUPPL-19 FLUOXETINE HYDROCHLORIDE MARKSANS PHARMA Labeling Approval
10/21/2014 LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA #076050		 SUPPL-21 LORATADINE; PSEUDOEPHEDRINE SULFATE PERRIGO PHARMA INTL Manufacturing (CMC) Approval
10/21/2014 TERBUTALINE SULFATE
ANDA #076887		 SUPPL-7 TERBUTALINE SULFATE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/21/2014 AMLODIPINE BESYLATE
ANDA #078500		 SUPPL-3 AMLODIPINE BESYLATE WOCKHARDT Labeling Approval
10/21/2014 PARICALCITOL
NDA #201657		 ORIG-1 PARICALCITOL HOSPIRA Type 5 - New Formulation or New Manufacturer Approval
10/21/2014 ZOLEDRONIC ACID
ANDA #202472		 SUPPL-2 ZOLEDRONIC ACID ACTAVIS INC Labeling Approval
10/21/2014 ZOLEDRONIC ACID
ANDA #202472		 SUPPL-3 ZOLEDRONIC ACID ACTAVIS INC Labeling Approval
10/21/2014 FLUDEOXYGLUCOSE F18
ANDA #204463		 ORIG-1 FLUDEOXYGLUCOSE F-18 SOFIE Approval
10/21/2014 SODIUM FLUORIDE F-18
ANDA #204464		 ORIG-1 SODIUM FLUORIDE F-18 DECATUR Approval
10/22/2014 ALDACTONE
NDA #012151		 SUPPL-72 SPIRONOLACTONE PFIZER Labeling Approval
10/22/2014 ALDACTAZIDE
NDA #012616		 SUPPL-76 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE PFIZER Labeling Approval
10/22/2014 MS CONTIN
NDA #019516		 SUPPL-43 MORPHINE SULFATE KNOA PHARMA Labeling Approval
10/22/2014 OXYCONTIN
NDA #022272		 SUPPL-23 OXYCODONE HYDROCHLORIDE KNOA PHARMA Labeling Approval
10/22/2014 HYDROCHLOROTHIAZIDE
ANDA #040702		 SUPPL-6 HYDROCHLOROTHIAZIDE LEADING Manufacturing (CMC) Approval
10/22/2014 AMOXICILLIN
ANDA #065056		 SUPPL-20 AMOXICILLIN CHARTWELL RX Manufacturing (CMC) Approval
10/22/2014 TOPIRAMATE
ANDA #076314		 SUPPL-10 TOPIRAMATE NATCO Labeling Approval
10/22/2014 TOPIRAMATE
ANDA #076314		 SUPPL-11 TOPIRAMATE NATCO Labeling Approval
10/22/2014 NICOTINE POLACRILEX
ANDA #077007		 SUPPL-24 NICOTINE POLACRILEX PERRIGO R AND D Manufacturing (CMC) Approval
10/22/2014 TERBINAFINE HYDROCHLORIDE
ANDA #077511		 SUPPL-5 TERBINAFINE HYDROCHLORIDE SUN PHARMA CANADA Manufacturing (CMC) Approval
10/22/2014 DICLOFENAC SODIUM
ANDA #077863		 SUPPL-6 DICLOFENAC SODIUM UNIQUE Labeling Approval
10/22/2014 DICLOFENAC SODIUM
ANDA #090066		 SUPPL-2 DICLOFENAC SODIUM UNIQUE Labeling Approval
10/22/2014 SOTYLIZE
NDA #205108		 ORIG-1 SOTALOL HYDROCHLORIDE AZURITY Type 3 - New Dosage Form Approval
10/23/2014 SODIUM IODIDE I 131
NDA #016517		 SUPPL-12 SODIUM IODIDE I-131 CURIUM Manufacturing (CMC) Approval
10/23/2014 ASTELIN
NDA #020114		 SUPPL-26 AZELASTINE HYDROCHLORIDE RISING Labeling Approval
10/23/2014 ADRENACLICK
NDA #020800		 SUPPL-28 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
10/23/2014 TWINJECT
NDA #020800		 SUPPL-28 EPINEPHRINE IMPAX Manufacturing (CMC) Approval
10/23/2014 CANCIDAS
NDA #021227		 SUPPL-33 CASPOFUNGIN ACETATE MERCK Labeling Approval
10/23/2014 FINACEA
NDA #021470		 SUPPL-8 AZELAIC ACID LEO PHARMA AS Manufacturing (CMC) Approval
10/23/2014 LUVOX
NDA #021519		 SUPPL-7 FLUVOXAMINE MALEATE ANI PHARMS Manufacturing (CMC) Approval
10/23/2014 ULORIC
NDA #021856		 SUPPL-8 FEBUXOSTAT TAKEDA PHARMS USA Manufacturing (CMC) Approval
10/23/2014 SOMATULINE DEPOT
NDA #022074		 SUPPL-9 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
10/23/2014 MINOCIN
NDA #050444		 SUPPL-48 MINOCYCLINE HYDROCHLORIDE REMPEX Labeling Approval
10/23/2014 MIRTAZAPINE
ANDA #076312		 SUPPL-11 MIRTAZAPINE WATSON LABS Labeling Approval
10/23/2014 SULFAMETHOXAZOLE AND TRIMETHOPRIM
ANDA #078060		 SUPPL-13 SULFAMETHOXAZOLE; TRIMETHOPRIM CHARTWELL MOLECULES Manufacturing (CMC) Approval
10/23/2014 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-2 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
10/23/2014 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-4 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
10/23/2014 DIVALPROEX SODIUM
ANDA #078182		 SUPPL-6 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
10/23/2014 GABAPENTIN
ANDA #200651		 SUPPL-3 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
10/23/2014 ZETONNA
NDA #202129		 SUPPL-4 CICLESONIDE AZURITY Efficacy Approval
10/23/2014 ZETONNA
NDA #202129		 SUPPL-5 CICLESONIDE AZURITY Efficacy Approval
10/23/2014 ZETONNA
NDA #202129		 SUPPL-6 CICLESONIDE AZURITY Efficacy Approval
10/23/2014 PREGABALIN
ANDA #202269		 ORIG-1 PREGABALIN NOVEL LABS INC Tentative Approval
10/23/2014 TUDORZA PRESSAIR
NDA #202450		 SUPPL-4 ACLIDINIUM BROMIDE AZURITY Manufacturing (CMC) Approval
10/23/2014 IMMPHENTIV
NDA #203826		 SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
10/23/2014 PHENYLEPHRINE HYDROCHLORIDE
NDA #203826		 SUPPL-3 PHENYLEPHRINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
10/23/2014 AMMONIA N 13
ANDA #204465		 ORIG-1 AMMONIA N-13 SOFIE Approval
10/23/2014 ABACAVIR AND LAMIVUDINE
NDA #204915		 ORIG-1 ABACAVIR;LAMIVUDINE MYLAN LABS LTD Type 3 - New Dosage Form Tentative Approval
10/24/2014 DILATRATE-SR
NDA #019790		 SUPPL-11 ISOSORBIDE DINITRATE ENDO OPERATIONS Labeling Approval
10/24/2014 TOBRAMYCIN SULFATE
ANDA #065407		 SUPPL-5 TOBRAMYCIN SULFATE MYLAN LABS LTD Labeling Approval
10/24/2014 DICLOFENAC SODIUM
ANDA #074394		 SUPPL-42 DICLOFENAC SODIUM CHARTWELL RX Manufacturing (CMC) Approval
10/24/2014 SOTALOL HYDROCHLORIDE
ANDA #075429		 SUPPL-16 SOTALOL HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
10/24/2014 MIRTAZAPINE
ANDA #076119		 SUPPL-24 MIRTAZAPINE TEVA Labeling Approval
10/24/2014 MIRTAZAPINE
ANDA #076312		 SUPPL-9 MIRTAZAPINE WATSON LABS Labeling Approval
10/24/2014 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #076684		 SUPPL-3 ENOXAPARIN SODIUM AMPHASTAR PHARM Manufacturing (CMC) Approval
10/24/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #078381		 SUPPL-7 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
10/24/2014 VALACYCLOVIR HYDROCHLORIDE
ANDA #090682		 SUPPL-8 VALACYCLOVIR HYDROCHLORIDE AUROBINDO PHARMA Manufacturing (CMC) Approval
10/24/2014 AZELASTINE HYDROCHLORIDE
ANDA #091444		 ORIG-1 AZELASTINE HYDROCHLORIDE HIKMA Approval
10/24/2014 OXYMORPHONE HYDROCHLORIDE
ANDA #200792		 ORIG-1 OXYMORPHONE HYDROCHLORIDE PAR PHARM Approval
10/24/2014 IVERMECTIN
ANDA #204154		 ORIG-1 IVERMECTIN EDENBRIDGE PHARMS Approval
10/25/2014 CYCLOPHOSPHAMIDE
ANDA #040745		 SUPPL-3 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Labeling Approval
10/25/2014 NAPROXEN SODIUM
ANDA #074661		 SUPPL-54 NAPROXEN SODIUM PERRIGO Labeling Approval
10/25/2014 NAPROXEN SODIUM
ANDA #074661		 SUPPL-58 NAPROXEN SODIUM PERRIGO Labeling Approval
10/25/2014 NAPROXEN SODIUM
ANDA #074661		 SUPPL-62 NAPROXEN SODIUM PERRIGO Labeling Approval
10/25/2014 TOPIRAMATE
ANDA #077868		 SUPPL-8 TOPIRAMATE WATSON LABS Labeling Approval
10/25/2014 TOPIRAMATE
ANDA #077868		 SUPPL-11 TOPIRAMATE WATSON LABS Labeling Approval
10/26/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065373		 SUPPL-6 AMOXICILLIN; CLAVULANATE POTASSIUM HIKMA PHARMS Labeling Approval
10/26/2014 DICLOFENAC SODIUM
ANDA #075910		 SUPPL-20 DICLOFENAC SODIUM ACTAVIS ELIZABETH Labeling Approval
10/26/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077179		 SUPPL-20 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE TEVA PHARMS Labeling Approval
10/26/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #077183		 SUPPL-6 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
10/26/2014 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-5 DIVALPROEX SODIUM PH HEALTH Labeling Approval
10/26/2014 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-9 DIVALPROEX SODIUM PH HEALTH Labeling Approval
10/26/2014 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-10 DIVALPROEX SODIUM PH HEALTH Labeling Approval
10/26/2014 DIVALPROEX SODIUM
ANDA #078445		 SUPPL-12 DIVALPROEX SODIUM PH HEALTH Labeling Approval
10/26/2014 AMLODIPINE BESYLATE
ANDA #078453		 SUPPL-2 AMLODIPINE BESYLATE ORBION PHARMS Labeling Approval
10/26/2014 AMLODIPINE BESYLATE
ANDA #078453		 SUPPL-3 AMLODIPINE BESYLATE ORBION PHARMS Labeling Approval
10/26/2014 DONEPEZIL HYDROCHLORIDE
ANDA #090056		 SUPPL-6 DONEPEZIL HYDROCHLORIDE AUROBINDO Labeling Approval
10/26/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #090149		 SUPPL-4 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
10/26/2014 ATORVASTATIN CALCIUM
ANDA #091226		 SUPPL-6 ATORVASTATIN CALCIUM MYLAN PHARMS INC Labeling Approval
10/26/2014 QUETIAPINE FUMARATE
ANDA #202152		 SUPPL-2 QUETIAPINE FUMARATE ACCORD HLTHCARE Labeling Approval
10/27/2014 DRAXIMAGE DTPA
NDA #018511		 SUPPL-25 TECHNETIUM TC-99M PENTETATE KIT JUBILANT Manufacturing (CMC) Approval
10/27/2014 TRANDATE
NDA #018716		 SUPPL-27 LABETALOL HYDROCHLORIDE ALVOGEN Manufacturing (CMC) Approval
10/27/2014 FLUOCINONIDE
NDA #019117		 SUPPL-38 FLUOCINONIDE SUN PHARMA CANADA Manufacturing (CMC) Approval
10/27/2014 NASONEX
NDA #020762		 SUPPL-50 MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
10/27/2014 ORFADIN
NDA #021232		 SUPPL-15 NITISINONE SWEDISH ORPHAN Manufacturing (CMC) Approval
10/27/2014 RITALIN LA
NDA #021284		 SUPPL-25 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
10/27/2014 ULTRAM ER
NDA #021692		 SUPPL-12 TRAMADOL HYDROCHLORIDE VALEANT PHARMS Manufacturing (CMC) Approval
10/27/2014 BYSTOLIC
NDA #021742		 SUPPL-19 NEBIVOLOL HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
10/27/2014 ZYFLO CR
NDA #022052		 SUPPL-10 ZILEUTON CHIESI Manufacturing (CMC) Approval
10/27/2014 SERTRALINE HYDROCHLORIDE
ANDA #076882		 SUPPL-13 SERTRALINE HYDROCHLORIDE MACLEODS PHARMS Labeling Approval
10/27/2014 SERTRALINE HYDROCHLORIDE
ANDA #076882		 SUPPL-14 SERTRALINE HYDROCHLORIDE MACLEODS PHARMS Labeling Approval
10/27/2014 SERTRALINE HYDROCHLORIDE
ANDA #076882		 SUPPL-15 SERTRALINE HYDROCHLORIDE MACLEODS PHARMS Labeling Approval
10/27/2014 SERTRALINE HYDROCHLORIDE
ANDA #077670		 SUPPL-21 SERTRALINE HYDROCHLORIDE LUPIN Labeling Approval
10/27/2014 SERTRALINE HYDROCHLORIDE
ANDA #077670		 SUPPL-24 SERTRALINE HYDROCHLORIDE LUPIN Labeling Approval
10/27/2014 DEXTROMETHORPHAN POLISTIREX
ANDA #091135		 SUPPL-2 DEXTROMETHORPHAN POLISTIREX TRIS PHARMA INC Manufacturing (CMC) Approval
10/27/2014 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263		 SUPPL-2 LEVOCETIRIZINE DIHYDROCHLORIDE PADAGIS US Manufacturing (CMC) Approval
10/27/2014 ADAPALENE
ANDA #201000		 ORIG-1 ADAPALENE ACTAVIS MID ATLANTIC Approval
10/27/2014 SIROLIMUS
ANDA #201578		 ORIG-1 SIROLIMUS DR REDDYS Approval
10/27/2014 DELZICOL
NDA #204412		 SUPPL-4 MESALAMINE ABBVIE Labeling Approval
10/27/2014 CARISOPRODOL
ANDA #205085		 ORIG-1 CARISOPRODOL ORIENT PHARMA CO LTD Approval
10/27/2014 NEVIRAPINE
ANDA #205651		 ORIG-1 NEVIRAPINE MYLAN Approval
10/28/2014 SORIATANE
NDA #019821		 SUPPL-25 ACITRETIN STIEFEL LABS INC Manufacturing (CMC) Approval
10/28/2014 IDKIT:HP
NDA #021314		 SUPPL-4 CITRIC ACID; UREA C-13 MERIDIAN BIOSCIENCE Labeling Approval
10/28/2014 SOMATULINE DEPOT
NDA #022074		 SUPPL-4 LANREOTIDE ACETATE IPSEN PHARMA Manufacturing (CMC) Approval
10/28/2014 NICARDIPINE HYDROCHLORIDE
NDA #022276		 SUPPL-9 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Manufacturing (CMC) Approval
10/28/2014 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
NDA #022276		 SUPPL-9 NICARDIPINE HYDROCHLORIDE HIKMA INTL PHARMS Manufacturing (CMC) Approval
10/28/2014 VIBRAMYCIN
NDA #050007		 SUPPL-28 DOXYCYCLINE HYCLATE PFIZER Manufacturing (CMC) Approval
10/28/2014 TRAMADOL HYDROCHLORIDE
ANDA #075986		 SUPPL-12 TRAMADOL HYDROCHLORIDE MYLAN Manufacturing (CMC) Approval
10/28/2014 HYDROCHLOROTHIAZIDE
ANDA #078164		 SUPPL-3 HYDROCHLOROTHIAZIDE AUROBINDO PHARMA Labeling Approval
10/28/2014 CARISOPRODOL
ANDA #090988		 ORIG-1 CARISOPRODOL NATCO Approval
10/28/2014 METOPROLOL TARTRATE
ANDA #200981		 ORIG-1 METOPROLOL TARTRATE RUBICON RESEARCH Approval
10/28/2014 PREGABALIN
ANDA #202998		 ORIG-1 PREGABALIN APOTEX INC Tentative Approval
10/28/2014 QUETIAPINE FUMARATE
ANDA #203390		 ORIG-1 QUETIAPINE FUMARATE ALEMBIC Approval
10/28/2014 HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #203839		 ORIG-1 HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE TRIS PHARMA INC Approval
10/28/2014 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203855		 ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE SCIEGEN PHARMS Approval
10/29/2014 BIO-TROPIN
BLA #019774		 SUPPL-28 SOMATROPIN FERRING Approval
10/29/2014 ZOMACTON
BLA #019774		 SUPPL-28 SOMATROPIN FERRING Approval
10/29/2014 NAROPIN
NDA #020533		 SUPPL-26 ROPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
10/29/2014 SINGULAIR
NDA #020830		 SUPPL-67 MONTELUKAST SODIUM ORGANON Manufacturing (CMC) Approval
10/29/2014 EDLUAR
NDA #021997		 SUPPL-6 ZOLPIDEM TARTRATE VIATRIS Labeling Approval
10/29/2014 LETAIRIS
NDA #022081		 SUPPL-32 AMBRISENTAN GILEAD REMS Approval
10/29/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065358		 SUPPL-3 AMOXICILLIN; CLAVULANATE POTASSIUM SANDOZ INC Labeling Approval
10/29/2014 SUMATRIPTAN SUCCINATE (AUTOINJECTOR)
ANDA #090495		 SUPPL-2 SUMATRIPTAN SUCCINATE DR REDDYS Labeling Approval
10/29/2014 HUMIRA
BLA #125057		 SUPPL-384 ADALIMUMAB ABBVIE INC Approval
10/29/2014 LETROZOLE
ANDA #202048		 ORIG-1 LETROZOLE LANNETT CO INC Approval
10/29/2014 DYMISTA
NDA #202236		 SUPPL-7 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
10/29/2014 CELECOXIB
ANDA #202240		 ORIG-1 CELECOXIB LUPIN Approval
10/29/2014 ISONIAZID
ANDA #202610		 ORIG-1 ISONIAZID THEPHARMANETWORK LLC Approval
10/29/2014 DONEPEZIL HYDROCHLORIDE
ANDA #203104		 ORIG-1 DONEPEZIL HYDROCHLORIDE TWI PHARMS Approval
10/29/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 ORIG-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Approval
10/29/2014 PIPERACILLIN AND TAZOBACTAM
ANDA #203557		 SUPPL-1 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM SANDOZ Approval
10/29/2014 FLUDEOXYGLUCOSE F18
ANDA #203801		 ORIG-1 FLUDEOXYGLUCOSE F-18 TRUSTEES UNIV PA Approval
10/29/2014 DONEPEZIL HYDROCHLORIDE
ANDA #203907		 ORIG-1 DONEPEZIL HYDROCHLORIDE SCIEGEN PHARMS Approval
10/29/2014 FLUDEOXYGLUCOSE F18
ANDA #204385		 ORIG-1 FLUDEOXYGLUCOSE F-18 CHILDRENS HOSP MI Approval
10/29/2014 FLUDEOXYGLUCOSE F18
ANDA #204525		 ORIG-1 FLUDEOXYGLUCOSE F-18 ISOLOGIC INNOVATIVE Approval
10/29/2014 SODIUM FLUORIDE F-18
ANDA #204541		 ORIG-1 SODIUM FLUORIDE F-18 ESSENTIAL ISOTOPES Approval
10/29/2014 XIGDUO XR
NDA #205649		 ORIG-1 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Type 4 - New Combination Approval
10/30/2014 LOPRESSOR
NDA #017963		 SUPPL-69 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
10/30/2014 LOPRESSOR
NDA #017963		 SUPPL-70 METOPROLOL TARTRATE VALIDUS PHARMS Manufacturing (CMC) Approval
10/30/2014 LOCOID
NDA #018514		 SUPPL-13 HYDROCORTISONE BUTYRATE BAUSCH Labeling Approval
10/30/2014 NICORETTE
NDA #018612		 SUPPL-74 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2014 NICORETTE (MINT)
NDA #018612		 SUPPL-74 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2014 LOCOID
NDA #018652		 SUPPL-10 HYDROCORTISONE BUTYRATE PRECISION DERMAT Labeling Approval
10/30/2014 HUMULIN R
BLA #018780		 SUPPL-149 INSULIN HUMAN LILLY Approval
10/30/2014 HUMULIN R
BLA #018780		 SUPPL-149 INSULIN RECOMBINANT HUMAN LILLY Approval
10/30/2014 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-149 INSULIN HUMAN LILLY Approval
10/30/2014 HUMULIN R PEN
BLA #018780		 SUPPL-149 INSULIN RECOMBINANT HUMAN LILLY Approval
10/30/2014 LOCOID
NDA #019116		 SUPPL-9 HYDROCORTISONE BUTYRATE BAUSCH Labeling Approval
10/30/2014 DIFLUCAN
NDA #019949		 SUPPL-60 FLUCONAZOLE PFIZER Labeling Approval
10/30/2014 NICORETTE
NDA #020066		 SUPPL-55 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2014 NICORETTE (MINT)
NDA #020066		 SUPPL-55 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
10/30/2014 DIFLUCAN
NDA #020090		 SUPPL-44 FLUCONAZOLE PFIZER Labeling Approval
10/30/2014 AGRYLIN
NDA #020333		 SUPPL-22 ANAGRELIDE HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
10/30/2014 ORFADIN
NDA #021232		 SUPPL-14 NITISINONE SWEDISH ORPHAN Manufacturing (CMC) Approval
10/30/2014 ZAVESCA
NDA #021348		 SUPPL-11 MIGLUSTAT ACTELION Manufacturing (CMC) Approval
10/30/2014 SYMBYAX
NDA #021520		 SUPPL-43 FLUOXETINE HYDROCHLORIDE; OLANZAPINE LILLY Manufacturing (CMC) Approval
10/30/2014 NASCOBAL
NDA #021642		 SUPPL-22 CYANOCOBALAMIN ENDO OPERATIONS Manufacturing (CMC) Approval
10/30/2014 NUTRESTORE
NDA #021667		 SUPPL-5 L-GLUTAMINE EMMAUS MEDCL Manufacturing (CMC) Approval
10/30/2014 BYSTOLIC
NDA #021742		 SUPPL-18 NEBIVOLOL HYDROCHLORIDE ALLERGAN Manufacturing (CMC) Approval
10/30/2014 KEPPRA
NDA #021872		 SUPPL-16 LEVETIRACETAM UCB INC Efficacy Approval
10/30/2014 VYVANSE
NDA #021977		 SUPPL-35 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Manufacturing (CMC) Approval
10/30/2014 LOCOID
NDA #022076		 SUPPL-5 HYDROCORTISONE BUTYRATE BAUSCH Labeling Approval
10/30/2014 ZYPREXA RELPREVV
NDA #022173		 SUPPL-23 OLANZAPINE PAMOATE CHEPLAPHARM REMS Approval
10/30/2014 DOCEFREZ
NDA #022534		 SUPPL-4 DOCETAXEL SUN PHARM Labeling Approval
10/30/2014 DOCETAXEL
NDA #022534		 SUPPL-4 DOCETAXEL SUN PHARM Labeling Approval
10/30/2014 LEVOTHYROXINE SODIUM
ANDA #076187		 SUPPL-22 LEVOTHYROXINE SODIUM MYLAN Manufacturing (CMC) Approval
10/30/2014 GABAPENTIN
ANDA #090705		 SUPPL-8 GABAPENTIN INVAGEN PHARMS Labeling Approval
10/30/2014 QUETIAPINE FUMARATE
ANDA #202152		 SUPPL-1 QUETIAPINE FUMARATE ACCORD HLTHCARE Labeling Approval
10/30/2014 TUDORZA PRESSAIR
NDA #202450		 SUPPL-3 ACLIDINIUM BROMIDE AZURITY Labeling Approval
10/30/2014 MYCOPHENOLATE SODIUM
ANDA #202720		 ORIG-1 MYCOPHENOLATE SODIUM TEVA PHARMS USA Approval
10/30/2014 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Approval
10/30/2014 MONTELUKAST SODIUM
ANDA #202859		 ORIG-1 MONTELUKAST SODIUM PHARMOBEDIENT Approval
10/30/2014 MONTELUKAST SODIUM
ANDA #203037		 ORIG-1 MONTELUKAST SODIUM PHARMOBEDIENT Approval
10/30/2014 AMMONIA N 13
ANDA #203783		 ORIG-1 AMMONIA N-13 BRIGHAM WOMENS HOSP Approval
10/30/2014 FLUDEOXYGLUCOSE F18
ANDA #203816		 ORIG-1 FLUDEOXYGLUCOSE F-18 BRIGHAM WOMENS Approval
10/30/2014 FLUDEOXYGLUCOSE F18
ANDA #203937		 ORIG-1 FLUDEOXYGLUCOSE F-18 HOT SHOTS NM LLC Approval
10/30/2014 OMTRYG
NDA #204977		 SUPPL-1 OMEGA-3-ACID ETHYL ESTERS TYPE A OSMOTICA PHARM US Manufacturing (CMC) Approval
10/30/2014 ZYKADIA
NDA #205755		 SUPPL-1 CERITINIB NOVARTIS Manufacturing (CMC) Approval
10/31/2014 NUVARING
NDA #021187		 SUPPL-25 ETHINYL ESTRADIOL; ETONOGESTREL ORGANON USA ORGANON Labeling Approval
10/31/2014 LEXAPRO
NDA #021323		 SUPPL-44 ESCITALOPRAM OXALATE ABBVIE Labeling Approval
10/31/2014 LEXAPRO
NDA #021365		 SUPPL-32 ESCITALOPRAM OXALATE ABBVIE Labeling Approval
10/31/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065317		 SUPPL-1 AMOXICILLIN; CLAVULANATE POTASSIUM APOTEX INC Labeling Approval
10/31/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065317		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM APOTEX INC Labeling Approval
10/31/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065333		 SUPPL-1 AMOXICILLIN; CLAVULANATE POTASSIUM APOTEX INC Labeling Approval
10/31/2014 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065333		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM APOTEX INC Labeling Approval
10/31/2014 ALPRAZOLAM
ANDA #074112		 SUPPL-24 ALPRAZOLAM SANDOZ Manufacturing (CMC) Approval
10/31/2014 ALPRAZOLAM
ANDA #074909		 SUPPL-19 ALPRAZOLAM SANDOZ Manufacturing (CMC) Approval
10/31/2014 CLOBETASOL PROPIONATE
ANDA #075338		 SUPPL-1 CLOBETASOL PROPIONATE AUROBINDO PHARMA USA Manufacturing (CMC) Approval
10/31/2014 BALANCED SALT
ANDA #075503		 SUPPL-1 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE EPIC PHARMA LLC Manufacturing (CMC) Approval
10/31/2014 ISOSORBIDE MONONITRATE
ANDA #075522		 SUPPL-12 ISOSORBIDE MONONITRATE DEXCEL LTD Manufacturing (CMC) Approval
10/31/2014 OMEPRAZOLE
ANDA #075757		 SUPPL-32 OMEPRAZOLE SANDOZ Manufacturing (CMC) Approval
10/31/2014 LISINOPRIL
ANDA #076164		 SUPPL-11 LISINOPRIL PRINSTON INC Manufacturing (CMC) Approval
10/31/2014 CIPROFLOXACIN
ANDA #076558		 SUPPL-22 CIPROFLOXACIN HIKMA Manufacturing (CMC) Approval
10/31/2014 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076558		 SUPPL-22 CIPROFLOXACIN HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
10/31/2014 ATENOLOL
ANDA #076900		 SUPPL-24 ATENOLOL ZYDUS PHARMS USA Labeling Approval
10/31/2014 OMEPRAZOLE
ANDA #091672		 ORIG-1 OMEPRAZOLE GLENMARK PHARMS LTD Approval
10/31/2014 FENOFIBRATE (MICRONIZED)
ANDA #201748		 ORIG-1 FENOFIBRATE SUN PHARM INDS LTD Approval
10/31/2014 DESONIDE
ANDA #202161		 ORIG-1 DESONIDE TARO Approval
10/31/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #202239		 SUPPL-1 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
10/31/2014 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #202239		 SUPPL-3 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
10/31/2014 LEVONORGESTREL
ANDA #202739		 ORIG-1 LEVONORGESTREL XIROMED Approval
10/31/2014 FLUVOXAMINE MALEATE
ANDA #203240		 ORIG-1 FLUVOXAMINE MALEATE TORRENT Approval
10/31/2014 LAMIVUDINE
ANDA #203564		 ORIG-1 LAMIVUDINE CHARTWELL MOLECULAR Approval
10/31/2014 PAROXETINE
ANDA #203854		 ORIG-1 PAROXETINE HYDROCHLORIDE PRINSTON INC Approval
10/31/2014 BUPROPION HYDROCHLORIDE
ANDA #203969		 ORIG-1 BUPROPION HYDROCHLORIDE TORRENT Approval
10/31/2014 CYCLOPHOSPHAMIDE
ANDA #204555		 ORIG-1 CYCLOPHOSPHAMIDE HENGRUI PHARMA Approval
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