FDA Drug Approvals July 2013.. Drug Name
Post# of 63700
Posted On: 07/12/2013 7:33:45 PM
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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