FDA Drugs July 2013. Previous Month Next
Post# of 63821
Posted On: 07/08/2013 7:55:29 PM
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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