Calendar

Week of May 22, 2023

May 24, 2023approval1197d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

May 24, 2023approval1197d agoONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ONDANSETRON HYDROCHLORIDE) — FDA approvalondansetron hydrochloride CR

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

full page →ondansetron hydrochloride CR →fda approvals ↗

May 25, 2023approval1196d agoSUSTOL (GRANISETRON) — FDA approvalgranisetron ER

Sponsor: HERON THERAPS INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →granisetron ER →fda approvals ↗

May 25, 2023approval1196d agoPAXLOVID (COPACKAGED) (NIRMATRELVIR) — FDA approvalPAXLOVID (COPACKAGED)

Sponsor: PFIZER. Form: TABLET. Route: ORAL

full page →PAXLOVID (COPACKAGED) →fda approvals ↗

May 25, 2023approval1196d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 25, 2023approval1196d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

May 26, 2023approval1195d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

May 26, 2023approval1195d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

May 26, 2023approval1195d agoTEZSPIRE (TEZEPELUMAB-EKKO) — FDA approvaltezepelumab

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →tezepelumab →fda approvals ↗

Week of May 29, 2023

May 30, 2023approval1191d agoFINTEPLA (FENFLURAMINE HYDROCHLORIDE) — FDA approvalfenfluramine hydrochloride

Sponsor: UCB INC. Form: SOLUTION. Route: ORAL

full page →fenfluramine hydrochloride →fda approvals ↗

Jun 1, 2023approval

Week of Jun 5, 2023

Jun 5, 2023approval1185d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Jun 5, 2023approval

Week of Jun 12, 2023

Jun 12, 2023approval1178d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗

Jun 12, 2023approval

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