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calendar

25,951 catalysts · 16,950 approval · 3,627 device 510k · 2,351 grant · 1,190 device recall · 1,071 device pma · 762 recall

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  • approval16,950
  • device 510k3,627
  • grant2,351
  • device recall1,190
  • device pma1,071
  • recall762
therapy area

no tagged catalysts yet

Week of Feb 23, 2015

2
›Mar 1, 2015approval4201d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗
›Mar 1, 2015approval4201d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Week of Mar 2, 2015

11
›Mar 2, 2015approval4200d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗
›Mar 2, 2015approval4200d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Mar 3, 2015approval4199d agoMORPHINE SULFATE — FDA approvalKapanol

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

full page →Kapanol →fda approvals ↗
›Mar 3, 2015approval4199d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
›Mar 3, 2015approval4199d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
›Mar 3, 2015approval4199d agoADDERALL XR 10 (AMPHETAMINE ASPARTATE) — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: TAKEDA PHARMS USA. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Mar 4, 2015approval4198d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗
›Mar 4, 2015approval4198d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: TABLET. Route: ORAL

full page →tedizolid phosphate →fda approvals ↗
›Mar 4, 2015approval4198d agoSIVEXTRO (TEDIZOLID PHOSPHATE) — FDA approvaltedizolid phosphate

Sponsor: CUBIST PHARMS LLC. Form: POWDER. Route: INTRAVENOUS

full page →tedizolid phosphate →fda approvals ↗
›Mar 6, 2015approval4196d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Mar 6, 2015approval4196d agoOMEPRAZOLE — FDA approvalomeprazole DR

Sponsor: DEXCEL PHARMA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →omeprazole DR →fda approvals ↗

Week of Mar 9, 2015

14
›Mar 9, 2015approval4193d agoKALYDECO (IVACAFTOR) — FDA approvalVertex, Inc.

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

full page →fda approvals ↗
›Mar 9, 2015approval4193d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →dulaglutide →fda approvals ↗
›Mar 9, 2015approval4193d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

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

full page →fda approvals ↗
›Mar 9, 2015approval4193d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗
›Mar 9, 2015approval4193d agoDILAUDID (HYDROMORPHONE HYDROCHLORIDE) — FDA approvalSpecGx LLC

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

full page →fda approvals ↗
›Mar 9, 2015approval4193d agoVICTOZA (LIRAGLUTIDE) — FDA approvalSaxenda

Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →Saxenda →fda approvals ↗
›Mar 10, 2015approval4192d agoUNITUXIN (DINUTUXIMAB) — FDA approvalUNITED THERAPEUTICS Corp

Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗
›Mar 11, 2015approval4191d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

Sponsor: LEO PHARMA AS. Form: CREAM. Route: TOPICAL

full page →calcipotriene →fda approvals ↗
›Mar 11, 2015approval4191d agoDOVONEX (CALCIPOTRIENE) — FDA approvalcalcipotriene

Sponsor: LEO PHARMA AS. Form: OINTMENT. Route: TOPICAL

full page →calcipotriene →fda approvals ↗
›Mar 12, 2015approval4190d agoAFREZZA (INSULIN RECOMBINANT HUMAN) — FDA approvalinsulin human

Sponsor: MANNKIND. Form: POWDER. Route: INHALATION

full page →insulin human →fda approvals ↗
›Mar 12, 2015approval4190d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗
›Mar 13, 2015approval4189d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Mar 13, 2015approval4189d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Mar 13, 2015approval4189d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗

Week of Mar 16, 2015

11
›Mar 16, 2015approval4186d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗
›Mar 16, 2015approval4186d agoCONTRAVE (BUPROPION HYDROCHLORIDE) — FDA approvalIpca Pharmaceuticals Inc

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

full page →fda approvals ↗
›Mar 17, 2015approval4185d agoKALYDECO (IVACAFTOR) — FDA approvalivacaftor

Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL

full page →ivacaftor →fda approvals ↗
›Mar 18, 2015approval4184d agoIMODIUM MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE) — FDA approvalBionpharma Inc

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

full page →fda approvals ↗
›Mar 18, 2015approval4184d agoONDANSETRON HYDROCHLORIDE — FDA approvalondansetron hydrochloride CR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →ondansetron hydrochloride CR →fda approvals ↗
›Mar 18, 2015approval4184d agoZIPRASIDONE HYDROCHLORIDE — FDA approvalLupin Ltd

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

full page →fda approvals ↗
›Mar 20, 2015approval4182d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

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

full page →divalproex sodium DR →fda approvals ↗
›Mar 20, 2015approval4182d agoCENESTIN (ESTROGENS, CONJUGATED SYNTHETIC A) — FDA approvalCENESTIN

Sponsor: ASPEN. Form: TABLET. Route: ORAL

full page →CENESTIN →fda approvals ↗
›Mar 20, 2015approval4182d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Mar 20, 2015approval4182d agoMETHYLIN ER (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalMETHYLIN ER

Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →METHYLIN ER →fda approvals ↗
›Mar 20, 2015approval4182d agoXELODA (CAPECITABINE) — FDA approvalArmas Pharmaceuticals Inc

Sponsor: CHEPLAPHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Week of Mar 23, 2015

12
›Mar 24, 2015approval4178d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL ODT (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL CD (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Mar 24, 2015approval4178d agoLAMICTAL XR (LAMOTRIGINE) — FDA approvalLAMOTRIGINE

Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗
›Mar 25, 2015approval4177d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Mar 25, 2015approval4177d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Mar 25, 2015approval4177d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

full page →fda approvals ↗
›Mar 26, 2015approval4176d agoATELVIA (RISEDRONATE SODIUM) — FDA approvalAllergan Finance LLC

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

full page →fda approvals ↗
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