Calendar

Feb 3, 2015approval4227d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

Feb 3, 2015approval4227d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

Feb 3, 2015approval4227d agoLACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Feb 3, 2015approval4227d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Feb 3, 2015approval4227d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Feb 4, 2015approval4226d agoALEVE (NAPROXEN SODIUM) — FDA approvalNAPROXEN SODIUM

Sponsor: BAYER. Form: TABLET. Route: ORAL

full page →NAPROXEN SODIUM →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 4, 2015approval4226d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 5, 2015approval4225d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 5, 2015approval4225d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 6, 2015approval4224d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Feb 6, 2015approval4224d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: STRIDES PHARMA INTL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →Kapanol →fda approvals ↗

Week of Feb 9, 2015

Feb 9, 2015approval4221d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

Sponsor: AUROBINDO PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →amoxicillin →fda approvals ↗

Feb 9, 2015approval4221d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 10, 2015approval4220d agoMEN'S ROGAINE (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL

full page →fda approvals ↗

Feb 11, 2015approval4219d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 12, 2015approval4218d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 12, 2015approval4218d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 12, 2015approval4218d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

Feb 12, 2015approval4218d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Feb 12, 2015approval4218d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Feb 12, 2015approval4218d agoZOLADEX (GOSERELIN ACETATE) — FDA approvalgoserelin LA

Sponsor: TERSERA. Form: IMPLANT. Route: IMPLANTATION

full page →goserelin LA →fda approvals ↗

Feb 13, 2015approval4217d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Feb 13, 2015approval4217d agoLETROZOLE — FDA approvalLETROZOLE