Calendar

pharmadog

Week of Jun 24, 2024

Jun 24, 2024approval801d agoAMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN) — FDA approvalamoxicillin

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

full page →amoxicillin →fda approvals ↗

Jun 25, 2024approval800d agoVANFLYTA (QUIZARTINIB DIHYDROCHLORIDE) — FDA approvalquizartinib dihydrochloride

Sponsor: DAIICHI SANKYO INC. Form: TABLET. Route: ORAL

full page →quizartinib dihydrochloride →fda approvals ↗

Jun 25, 2024approval800d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Jun 26, 2024approval799d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

Jun 26, 2024approval799d agoISOTRETINOIN — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jun 26, 2024approval799d agoONDANSETRON — FDA approvalSandoz Inc

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

full page →fda approvals ↗

Jun 26, 2024approval799d agoONDANSETRON — FDA approvalSandoz Inc

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

full page →fda approvals ↗

Jun 26, 2024approval799d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jun 27, 2024approval798d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

Jun 28, 2024approval797d agoABSORICA (ISOTRETINOIN) — FDA approvalSun Pharmaceutical Industries Ltd

Sponsor: SUN PHARM INDS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jun 28, 2024approval797d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →PYZCHIVA →fda approvals ↗

Jun 28, 2024approval797d agoPYZCHIVA (USTEKINUMAB-TTWE) — FDA approvalPYZCHIVA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →PYZCHIVA →fda approvals ↗

Jun 28, 2024approval797d agoHADLIMA (ADALIMUMAB-BWWD) — FDA approvalHADLIMA

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →HADLIMA →fda approvals ↗

Jun 28, 2024approval797d agoAXTLE (PEMETREXED DIPOTASSIUM) — FDA approvalAXTLE

Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS

full page →AXTLE →fda approvals ↗

Jun 28, 2024approval797d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Jul 8, 2024

Jul 8, 2024approval787d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METRONIDAZOLE →fda approvals ↗

Jul 8, 2024approval787d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jul 8, 2024approval787d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

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

full page →fda approvals ↗

Jul 8, 2024approval787d agoCALCIUM CHLORIDE 10% (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →CALCIUM CHLORIDE 10% →fda approvals ↗

Jul 9, 2024approval786d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

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

full page →apalutamide →fda approvals ↗

Jul 9, 2024approval786d agoZORYVE (ROFLUMILAST) — FDA approvalArcutis Biotherapeutics, Inc.

Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Jul 10, 2024approval785d agoDIVALPROEX SODIUM — FDA approvaldivalproex sodium DR

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Jul 10, 2024approval785d agoCEREZYME (IMIGLUCERASE) — FDA approvalimiglucerase

Sponsor: GENZYME. Form: INJECTABLE. Route: INJECTION

full page →imiglucerase →fda approvals ↗

Jul 10, 2024approval785d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗

Jul 11, 2024approval784d agoMEKINIST (TRAMETINIB) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: SOLUTION. Route: ORAL

full page →Spexotras →fda approvals ↗

Jul 11, 2024approval784d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Jul 11, 2024approval784d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

Jul 11, 2024approval784d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

Jul 11, 2024approval784d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jul 11, 2024approval784d agoBOSENTAN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jul 11, 2024approval784d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Jul 11, 2024approval784d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX. Form: INJECTABLE. Route: INTRAVENOUS

full page →IBANDRONATE SODIUM →fda approvals ↗

Jul 11, 2024approval784d agoAMONDYS 45 (CASIMERSEN) — FDA approvalcasimersen

Sponsor: SAREPTA THERAPS INC. Form: SOLUTION. Route: INTRAVENOUS

full page →casimersen →fda approvals ↗

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