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FDA Drugs July 2013.

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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 07/05/201
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