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calendar

27,085 catalysts · 17,272 approval · 3,896 device 510k · 2,448 grant · 1,413 device recall · 1,196 device pma · 860 recall

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approval17,272
device 510k3,896
grant2,448
device recall1,413
device pma1,196
recall860

therapy area

no tagged catalysts yet

Week of Oct 27, 2014

›Oct 29, 2014approval4323d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

Sponsor: SANDOZ INC. Form: FOR SUSPENSION. Route: ORAL

full page →amoxicillin →fda approvals ↗

›Oct 29, 2014approval4323d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Oct 29, 2014approval4323d agoCELECOXIB — FDA approvalCelebrex

Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL

full page →Celebrex →fda approvals ↗

›Oct 30, 2014approval4322d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →fda approvals ↗

›Oct 30, 2014approval4322d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

full page →quetiapine fumarate ER →fda approvals ↗

›Oct 30, 2014approval4322d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 2, 2014approval4319d agoPRAVASTATIN SODIUM — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

Week of Nov 3, 2014

›Nov 4, 2014approval4317d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

›Nov 4, 2014approval4317d agoESCITALOPRAM OXALATE — FDA approvalAbbVie Inc.

Sponsor: SUN PHARMA CANADA. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Nov 5, 2014approval4316d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

›Nov 5, 2014approval4316d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 6, 2014approval4315d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

Sponsor: ABBVIE INC. Form: VIAL

full page →adalimumab →fda approvals ↗

›Nov 7, 2014approval4314d agoPROPOFOL — FDA approvalPROPOFOL

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →PROPOFOL →fda approvals ↗

›Nov 8, 2014approval4313d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 8, 2014approval4313d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Nov 8, 2014approval4313d agoDIVALPROEX SODIUM — FDA approvalUnichem Pharmaceuticals (USA) Inc

Sponsor: SUN PHARM INDS. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →fda approvals ↗

›Nov 8, 2014approval4313d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

›Nov 8, 2014approval4313d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ZYDUS PHARMS USA INC. Form: TABLET. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

Week of Nov 10, 2014

›Nov 10, 2014approval4311d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗

›Nov 10, 2014approval4311d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 10, 2014approval4311d agoHUMATROPE (SOMATROPIN) — FDA approvalEMD Serono Inc

Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

›Nov 11, 2014approval4310d agoJUXTAPID (LOMITAPIDE MESYLATE) — FDA approvalChiesi USA Inc

Sponsor: CHIESI. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 12, 2014approval4309d agoCLINDAMYCIN HYDROCHLORIDE — FDA approvalMicro Labs USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

›Nov 12, 2014approval4309d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: PAI HOLDINGS. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Nov 13, 2014approval4308d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

›Nov 14, 2014approval4307d agoOBREDON (GUAIFENESIN) — FDA approvalMoberg Pharma AB

Sponsor: SOVEREIGN PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

›Nov 14, 2014approval4307d agoVYVANSE (LISDEXAMFETAMINE DIMESYLATE) — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

›Nov 16, 2014approval4305d agoMORPHINE SULFATE — FDA approvalKapanol

Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS

full page →Kapanol →fda approvals ↗

Week of Nov 17, 2014

›Nov 17, 2014approval4304d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 17, 2014approval4304d agoTOPIRAMATE — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Nov 17, 2014approval4304d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: SOLUTION. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

›Nov 17, 2014approval4304d agoNUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approvaltapentadol hydrochloride ER

Sponsor: COLLEGIUM PHARM INC. Form: SOLUTION. Route: ORAL

full page →tapentadol hydrochloride ER →fda approvals ↗

›Nov 17, 2014approval4304d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

›Nov 17, 2014approval4304d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

›Nov 20, 2014approval4301d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Nov 20, 2014approval4301d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

›Nov 20, 2014approval4301d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

›Nov 20, 2014approval4301d agoPRIFTIN (RIFAPENTINE) — FDA approvalrifapentine

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →rifapentine →fda approvals ↗