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Week of Nov 30, 2015

32

Nov 30, 2015approval3906d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Nov 30, 2015approval3906d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Nov 30, 2015approval3906d agoFOSAMAX (ALENDRONATE SODIUM) — FDA approvalALENDRONATE SODIUM

Sponsor: ORGANON. Form: TABLET. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Nov 30, 2015approval3906d agoFOSAMAX PLUS D (ALENDRONATE SODIUM) — FDA approval(alendronate sodium + cholecalciferol)

Sponsor: ORGANON LLC. Form: TABLET. Route: ORAL

full page →(alendronate sodium + cholecalciferol) →fda approvals ↗

Nov 30, 2015approval3906d agoCLOMIPRAMINE HYDROCHLORIDE — FDA approvalTruPharma LLC

Sponsor: TARO. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Nov 30, 2015approval3906d agoCLOMIPRAMINE HYDROCHLORIDE — FDA approvalTruPharma LLC

Sponsor: TARO. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Dec 1, 2015approval3905d agoPRAVASTATIN SODIUM — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 1, 2015approval3905d agoPRAVASTATIN SODIUM — FDA approvalSenores Pharmaceuticals Inc

Sponsor: SENORES PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 1, 2015approval3905d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 1, 2015approval3905d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Dec 2, 2015approval3904d agoKARBINAL ER (CARBINOXAMINE MALEATE) — FDA approvalAYTU BIOPHARMA, INC

Sponsor: AYTU. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Dec 2, 2015approval3904d agoIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE) — FDA approvalBionpharma Inc

Sponsor: KENVUE BRANDS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2015approval3904d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

Dec 2, 2015approval3904d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Dec 3, 2015approval3903d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 4, 2015approval3902d agoQUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalCOLLEGIUM PHARMACEUTICAL, INC

Sponsor: NEXTWAVE PHARMS. Form: TABLET, EXTENDED RELEASE, CHEWABLE. Route: ORAL

full page →fda approvals ↗

Dec 4, 2015approval3902d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 4, 2015approval3902d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 4, 2015approval3902d agoTUZISTRA XR (CHLORPHENIRAMINE POLISTIREX) — FDA approvalTUZISTRA XR

Sponsor: TRIS PHARMA INC. Form: SUSPENSION, EXTENDED RELEASE. Route: ORAL

full page →TUZISTRA XR →fda approvals ↗

Dec 4, 2015approval3902d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →(empagliflozin + linagliptin) →fda approvals ↗

Dec 4, 2015approval3902d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Dec 4, 2015approval3902d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

full page →SYNJARDY →fda approvals ↗

Dec 4, 2015approval3902d agoFOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) — FDA approvaldexmethylphenidate hydrochloride ER

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

full page →dexmethylphenidate hydrochloride ER →fda approvals ↗

Dec 4, 2015approval3902d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Week of Dec 7, 2015

12

Dec 8, 2015approval3898d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

Sponsor: ALKERMES. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →naltrexone ER →fda approvals ↗

Dec 9, 2015approval

Week of Dec 14, 2015

6

Dec 14, 2015approval3892d agoRYTARY (CARBIDOPA) — FDA approvalOrganon & Co.

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

full page →fda approvals ↗

Dec 14, 2015approval

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