Calendar

Jan 14, 2015approval4247d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalFLUOXETINE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: CAPSULE. Route: ORAL

full page →FLUOXETINE HYDROCHLORIDE →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Jan 15, 2015approval4246d agoXARELTO (RIVAROXABAN) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON HYDROCHLORIDE — FDA approvalRedHill Biopharma Ltd.

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: SUN PHARM INDS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Jan 15, 2015approval4246d agoONDANSETRON — FDA approvalSandoz Inc

Sponsor: SUN PHARM INDS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →fda approvals ↗

Jan 16, 2015approval4245d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Jan 16, 2015approval4245d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: RISING. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Jan 17, 2015approval4244d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Week of Jan 19, 2015

Jan 20, 2015approval4241d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Jan 20, 2015approval4241d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: TORRENT PHARMS. Form: TABLET, CHEWABLE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Jan 20, 2015approval4241d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Jan 20, 2015approval4241d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

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

full page →carbamazepine ER →fda approvals ↗

Jan 20, 2015approval4241d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Jan 20, 2015approval4241d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Jan 20, 2015approval4241d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Jan 20, 2015approval4241d agoCONZIP (TRAMADOL HYDROCHLORIDE) — FDA approvalTrigen Laboratories Inc

Sponsor: CIPHER PHARMS INC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Jan 20, 2015approval4241d agoFENTANYL CITRATE — FDA approvalEffentora

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →Effentora →fda approvals ↗

Jan 20, 2015approval4241d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →ondansetron hydrochloride CR →fda approvals ↗

Jan 20, 2015approval4241d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Jan 20, 2015approval4241d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Jan 21, 2015approval4240d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 22, 2015approval4239d agoDOXIL (LIPOSOMAL) (DOXORUBICIN HYDROCHLORIDE) — FDA approvalDoxil

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

full page →Doxil →fda approvals ↗

Jan 23, 2015approval4238d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

Jan 23, 2015approval4238d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗

Week of Jan 26, 2015

Jan 26, 2015approval4235d agoVIVITROL (NALTREXONE) — FDA approvalnaltrexone ER

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

full page →naltrexone ER →fda approvals ↗

Jan 26, 2015approval4235d agoDILAUDID (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalSpecGx LLC

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

full page →fda approvals ↗

Jan 26, 2015approval4235d agoOXAYDO (OXYCODONE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ZYLA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 26, 2015approval4235d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗

Jan 26, 2015approval4235d agoBREVIBLOC (ESMOLOL HYDROCHLORIDE) — FDA approvalESMOLOL HYDROCHLORIDE

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

full page →ESMOLOL HYDROCHLORIDE →fda approvals ↗

Jan 27, 2015approval4234d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Jan 29, 2015approval4232d agoPREZCOBIX (COBICISTAT) — FDA approvalGILEAD SCIENCES, INC.

Sponsor: JANSSEN PRODS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 29, 2015approval4232d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 30, 2015approval4231d agoABREVA (DOCOSANOL) — FDA approvalPL Developments Copiague LLC

Sponsor: HALEON US HOLDINGS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Jan 30, 2015approval4231d agoSCOPOLAMINE — FDA approvalRiconpharma LLC

Sponsor: PADAGIS US. Form: SYSTEM. Route: TRANSDERMAL

full page →fda approvals ↗

Jan 30, 2015approval4231d agoRECLAST (ZOLEDRONIC ACID) — FDA approvalZOLEDRONIC ACID

Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS

full page →ZOLEDRONIC ACID →fda approvals ↗

Jan 30, 2015approval4231d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗

Jan 30, 2015approval4231d agoDEPO-SUBQ PROVERA 104 (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →medroxyprogesterone acetate →fda approvals ↗

Jan 30, 2015approval4231d agoDEPO-PROVERA (MEDROXYPROGESTERONE ACETATE) — FDA approvalmedroxyprogesterone acetate

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →medroxyprogesterone acetate →fda approvals ↗

Jan 30, 2015approval4231d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗

Jan 30, 2015approval4231d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

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

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

Jan 30, 2015approval4231d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Jan 30, 2015approval4231d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Week of Jan 12, 2015

Week of Jan 19, 2015

Week of Jan 26, 2015

Week of Feb 2, 2015