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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