FDA Drug Approvals July 2013.. Drug Name and FDA

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FDA Drug Approvals July 2013..


Drug Name

and
FDA Appl. #

Suppl. #

Active
Ingredients

Company

Approval
Type

Approval
Date
ORTHO EVRA
(NDA # 021180)

044 ETHINYL ESTRADIOL; NORELGESTROMIN JANSSEN PHARMS Labeling Revision 07/01/2013
TRACLEER
(NDA # 021290)

025 BOSENTAN ACTELION PHARMS LTD Labeling Revision 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 078739)

000 RIZATRIPTAN BENZOATE SANDOZ Approval 07/01/2013
FINASTERIDE
(ANDA # 090060)

000 FINASTERIDE HETERO LABS LTD III Approval 07/01/2013
FINASTERIDE
(ANDA # 090508)

000 FINASTERIDE SUN PHARMA GLOBAL Approval 07/01/2013
RASAGILINE MESYLATE
(ANDA # 201823)

000 RASAGILINE MESYLATE WATSON LABS INC Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 201914)

000 RIZATRIPTAN BENZOATE GLENMARK GENERICS Approval 07/01/2013
ARIPIPRAZOLE
(ANDA # 202102)

000 ARIPIPRAZOLE ALEMBIC PHARMS LTD Tentative Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 202477)

000 RIZATRIPTAN BENZOATE APOTEX INC Approval 07/01/2013
GATIFLOXACIN
(ANDA # 202653)

000 GATIFLOXACIN LUPIN LTD Tentative Approval 07/01/2013
RILUZOLE
(ANDA # 203042)

000 RILUZOLE MYLAN PHARMS INC Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 203062)

000 RIZATRIPTAN BENZOATE AUROBINDO PHARMA LTD Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 203478)

000 RIZATRIPTAN BENZOATE NATCO PHARMA LTD Approval 07/01/2013
RIZATRIPTAN BENZOATE
(ANDA # 204339)

000 RIZATRIPTAN BENZOATE INVAGEN PHARMS Approval 07/01/2013
EFUDEX
(NDA # 016831)

056 FLUOROURACIL VALEANT PHARM INTL Manufacturing Change or Addition 07/02/2013
NASACORT AQ
(NDA # 020468)

033 TRIAMCINOLONE ACETONIDE SANOFI AVENTIS US Efficacy Supplement with Clinical Data to Support 07/02/2013
NASACORT AQ
(NDA # 020468)

034 TRIAMCINOLONE ACETONIDE SANOFI AVENTIS US Efficacy Supplement with Clinical Data to Support 07/02/2013
SPRIX
(NDA # 022382)

007 KETOROLAC TROMETHAMINE LUITPOLD Manufacturing Change or Addition 07/02/2013
ZIANA
(NDA # 050802)

014 CLINDAMYCIN PHOSPHATE; TRETINOIN MEDICIS Manufacturing Change or Addition 07/02/2013
ROSUVASTATIN CALCIUM
(ANDA # 079161)

000 ROSUVASTATIN CALCIUM MYLAN PHARMA Tentative Approval 07/02/2013
PEGASYS
(BLA # 103964)

5245 PEGINTERFERON ALFA-2A HOFFMAN-LA ROCHE Labeling Revision 07/02/2013
ACTEMRA
(BLA # 125276)

075 TOCILIZUMAB GENENTECH Labeling Revision 07/02/2013
SUBLIMAZE PRESERVATIVE FREE
(NDA # 016619)

034 FENTANYL CITRATE AKORN Labeling Revision 07/03/2013
TENEX
(NDA # 019032)

021 GUANFACINE HYDROCHLORIDE PROMIUS PHARMA Labeling Revision 07/03/2013
PERIOCHIP
(NDA # 020774)

013 CHLORHEXIDINE GLUCONATE DEXCEL PHARMA Manufacturing Change or Addition 07/03/2013
GEODON
(NDA # 020825)

041 ZIPRASIDONE HYDROCHLORIDE PFIZER Labeling Revision 07/03/2013
GEODON
(NDA # 020919)

027 ZIPRASIDONE MESYLATE PFIZER Labeling Revision 07/03/2013
BENICAR
(NDA # 021286)

027 OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
OXYTROL
(NDA # 021351)

007 OXYBUTYNIN WATSON LABS (UTAH) Manufacturing Change or Addition 07/03/2013
GEODON
(NDA # 021483)

007 ZIPRASIDONE HYDROCHLORIDE PFIZER INC Labeling Revision 07/03/2013
BENICAR HCT
(NDA # 021532)

022 HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
AZOR
(NDA # 022100)

022 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
CAPRELSA
(NDA # 022405)

004 VANDETANIB IPR PHARMS INC Labeling Revision 07/03/2013
GABAPENTIN
(ANDA # 076672)

000 GABAPENTIN TARO Approval 07/03/2013
PROLIA
(BLA # 125320)

113 DENOSUMAB AMGEN Labeling Revision 07/03/2013
XGEVA
(BLA # 125320)

113 DENOSUMAB AMGEN Labeling Revision 07/03/2013
TRIBENZOR
(NDA # 200175)

014 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Manufacturing Change or Addition 07/03/2013
TRIBENZOR
(NDA # 200175)

015 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL DAIICHI SANKYO Labeling Revision 07/03/2013
ZELBORAF
(NDA # 202429)

002 VEMURAFENIB HOFFMANN LA ROCHE Labeling Revision 07/03/2013
ZELBORAF
(NDA # 202429)

003 VEMURAFENIB HOFFMANN LA ROCHE Labeling Revision 07/03/2013
ZOLEDRONIC ACID
(NDA # 204016)

000 ZOLEDRONIC ACID HOSPIRA INC Tentative Approval 07/03/2013
ZUBSOLV
(NDA # 204242)

000 BUPRENORPHINE; NALOXONE OREXO AB Approval 07/03/2013
DILAUDID
(NDA # 019892)

023 HYDROMORPHONE HYDROCHLORIDE PURDUE PHARM PRODS Manufacturing Change or Addition 07/05/2013
SARAFEM
(NDA # 021860)

006 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
SARAFEM
(NDA # 021860)

007 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
SARAFEM
(NDA # 021860)

008 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
SARAFEM
(NDA # 021860)

009 FLUOXETINE HYDROCHLORIDE WARNER CHILCOTT LLC Labeling Revision 07/05/2013
DONEPEZIL HYDROCHLORIDE
(ANDA # 202114)

000 DONEPEZIL HYDROCHLORIDE ALVOGEN PINE BROOK Approval 07/05/2013
TRUVADA
(NDA # 021752)

039 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Manufacturing Change or Addition 07/08/2013
INTELENCE
(NDA # 022187)

015 ETRAVIRINE JANSSEN R AND D Manufacturing Change or Addition 07/08/2013
CEVIMELINE HYDROCHLORIDE
(ANDA # 091591)

001 CEVIMELINE HYDROCHLORIDE ROXANE Approval 07/08/2013
DIPRIVAN
(NDA # 019627)

060 PROPOFOL FRESENIUS KABI USA Manufacturing Change or Addition 07/09/2013
CIPRO HC
(NDA # 020805)

010 CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE ALCON PHARMS LTD Manufacturing Change or Addition 07/09/2013
OVIDREL
(NDA # 021149)

017 CHORIOGONADOTROPIN ALFA EMD SERONO Manufacturing Change or Addition 07/09/2013
SUSTIVA
(NDA # 021360)

032 EFAVIRENZ BRISTOL MYERS SQUIBB Manufacturing Change or Addition 07/09/2013
SYNERA
(NDA # 021623)

022 LIDOCAINE; TETRACAINE ZARS PHARM Manufacturing Change or Addition 07/09/2013
METHYLPHENIDATE HYDROCHLORIDE
(ANDA # 091695)

000 METHYLPHENIDATE HYDROCHLORIDE KUDCO IRELAND Approval 07/09/2013
METHYLPHENIDATE HYDROCHLORIDE
(ANDA # 091695)

000 METHYLPHENIDATE HYDROCHLORIDE KUDCO IRELAND Tentative Approval 07/09/2013
DELZICOL
(NDA # 204412)

001 MESALAMINE WARNER CHILCOTT LLC Manufacturing Change or Addition 07/09/2013
MONISTAT 7
(NDA # 017450)

063 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
MONISTAT 7
(NDA # 018520)

024 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
MONISTAT 3
(NDA # 018888)

015 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
LUPRON DEPOT
(NDA # 019732)

040 LEUPROLIDE ACETATE ABBOTT ENDOCRINE Labeling Revision 07/10/2013
MONISTAT 7 COMBINATION PACK
(NDA # 020288)

017 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
LUPRON DEPOT
(NDA # 020517)

035 LEUPROLIDE ACETATE ABBOTT ENDOCRINE Labeling Revision 07/10/2013
MONISTAT-3 COMBINATION PACK
(NDA # 020670)

022 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
MONISTAT 3
(NDA # 020827)

021 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
MONISTAT DUAL- PAK
(NDA # 020968)

003 MICONAZOLE NITRATE PERSONAL PRODS Manufacturing Change or Addition 07/10/2013
MONISTAT 3 COMBINATION PACK
(NDA # 021261)

014 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
MONISTAT 3 COMBINATION PACK (PREFILLED)
(NDA # 021261)

014 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
MONISTAT 1 COMBINATION PACK
(NDA # 021308)

019 MICONAZOLE NITRATE INSIGHT PHARMS Manufacturing Change or Addition 07/10/2013
OXYTROL
(NDA # 021351)

012 OXYBUTYNIN WATSON LABS (UTAH) Manufacturing Change or Addition 07/10/2013
LUVOX
(NDA # 021519)

006 FLUVOXAMINE MALEATE ANI PHARMS Manufacturing Change or Addition 07/10/2013
DURAPREP
(NDA # 021586)

004 IODINE POVACRYLEX; ISOPROPYL ALCOHOL 3M Manufacturing Change or Addition 07/10/2013
EXPAREL
(NDA # 022496)

004 BUPIVACAINE PACIRA PHARMS INC Manufacturing Change or Addition 07/10/2013
MORPHINE SULFATE
(NDA # 201517)

005 MORPHINE SULFATE LANNETT HOLDINGS INC Manufacturing Change or Addition 07/10/2013
STENDRA
(NDA # 202276)

004 AVANAFIL VIVUS Manufacturing Change or Addition 07/10/2013
KHEDEZLA
(NDA # 204683)

000 DESVENLAFAXINE OSMOTICA PHARM Approval 07/10/2013
FEMARA
(NDA # 020726)

025 LETROZOLE NOVARTIS PHARMS Manufacturing Change or Addition 07/11/2013
KETEK
(NDA # 021144)

016 TELITHROMYCIN SANOFI AVENTIS US Manufacturing Change or Addition 07/11/2013
TIROSINT
(NDA # 021924)

010 LEVOTHYROXINE SODIUM INSTITUT BIOCHIMIQUE Manufacturing Change or Addition 07/11/2013
NUCYNTA
(NDA # 022304)

007 TAPENTADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Revision 07/11/2013
NUCYNTA
(NDA # 022304)

008 TAPENTADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Revision 07/11/2013
NUCYNTA
(NDA # 022304)

009 TAPENTADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Revision 07/11/2013
NUCYNTA
(NDA # 022304)

011 TAPENTADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Revision 07/11/2013
NUCYNTA
(NDA # 022304)

012 TAPENTADOL HYDROCHLORIDE JANSSEN PHARMS Labeling Revision 07/11/2013
REPAGLINIDE
(ANDA # 077571)

000 REPAGLINIDE CARACO Approval 07/11/2013
OXYMORPHONE HYDROCHLORIDE
(ANDA # 079046)

000 OXYMORPHONE HYDROCHLORIDE ACTAVIS ELIZABETH Approval 07/11/2013
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
(ANDA # 090733)

000 OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN VINTAGE PHARMS Approval 07/11/2013
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
(ANDA # 090734)

000 OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN VINTAGE PHARMS Approval 07/11/2013
SUPRENZA
(NDA # 202088)

006 PHENTERMINE HYDROCHLORIDE CITIUS PHARMS Labeling Revision 07/11/2013
DECITABINE
(ANDA # 203131)

000 DECITABINE DR REDDYS LABS LTD Approval 07/11/2013
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
(NDA # 203667)

002 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE WARNER CHILCOTT LLC Labeling Revision 07/11/2013
GILOTRIF
(NDA # 201292)

000 AFATINIB BOEHRINGER INGELHEIM Approval 07/12/2013

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