Calendar

Week of Aug 25, 2008

Aug 25, 2008approval6564d agoESTRING (ESTRADIOL) — FDA approvalestradiol ER

Sponsor: PFIZER. Form: INSERT, EXTENDED RELEASE. Route: VAGINAL

full page →estradiol ER →fda approvals ↗

Aug 25, 2008approval6564d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

Aug 25, 2008approval6564d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GENUS LIFESCIENCES. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Aug 25, 2008approval6564d agoSALONPAS (MENTHOL) — FDA approvalHisamitsu America Inc

Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL

full page →fda approvals ↗

Aug 26, 2008approval6563d agoMETADATE CD (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETADATE CD

Sponsor: AYTU BIOPHARMA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →METADATE CD →fda approvals ↗

Aug 27, 2008approval6562d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Aug 29, 2008approval6560d agoSTALEVO 75 (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ORION PHARMA. Form: TABLET. Route: ORAL

full page →carbidopa →fda approvals ↗

Week of Sep 1, 2008

Sep 2, 2008approval6556d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 2, 2008approval

Week of Sep 8, 2008

Sep 8, 2008approval6550d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Week of Sep 15, 2008

Sep 15, 2008approval6543d agoSERTRALINE HYDROCHLORIDE — FDA approvalSERTRALINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →SERTRALINE HYDROCHLORIDE →fda approvals ↗

Sep 16, 2008approval

Week of Sep 22, 2008

Sep 23, 2008approval6535d agoCLOZAPINE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: IVAX SUB TEVA PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Sep 23, 2008approval

Week of Oct 6, 2008

Oct 7, 2008approval6521d agoAKTEN (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

Sponsor: THEA PHARMA. Form: GEL. Route: OPHTHALMIC

full page →Laryng-O-Jet →fda approvals ↗

Oct 8, 2008approval

Week of Oct 13, 2008

Oct 17, 2008approval6511d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

Sponsor: SANDOZ. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Week of Oct 20, 2008

Oct 20, 2008approval6508d agoFENTANYL-75 (FENTANYL) — FDA approvalDifGen Pharmaceuticals LLC

Sponsor: DIFGEN PHARMS. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL

full page →fda approvals ↗

Oct 23, 2008approval

Week of Oct 27, 2008

Oct 29, 2008approval6499d agoLEFLUNOMIDE — FDA approvalLEFLUNOMIDE

Sponsor: HERITAGE. Form: TABLET. Route: ORAL

full page →LEFLUNOMIDE →fda approvals ↗

Oct 31, 2008approval

Week of Nov 3, 2008

Nov 6, 2008approval6491d agoMINOCYCLINE HYDROCHLORIDE — FDA approvalMINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT. Form: CAPSULE. Route: ORAL

full page →MINOCYCLINE HYDROCHLORIDE →fda approvals ↗

Nov 7, 2008approval

Week of Nov 10, 2008

Nov 12, 2008approval6485d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Nov 12, 2008approval

Week of Nov 17, 2008

Nov 17, 2008approval6480d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Nov 18, 2008approval

Week of Nov 24, 2008

Nov 24, 2008approval6473d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

Nov 25, 2008approval

Week of Dec 15, 2008

Dec 18, 2008approval6449d agoMALARONE PEDIATRIC (ATOVAQUONE) — FDA approvalatovaquone

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →atovaquone →fda approvals ↗

Dec 18, 2008approval

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