FDA NDA · NDA221183

EVOXAC

Sponsor: COSETTE PHARMS NC

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
NDA221183
TYPE
NDA
ORIGINAL APPROVAL
2026-10-15
LATEST ACTION
2026-10-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

EVOXACPrescription
CEVIMELINE HYDROCHLORIDE 30MG · CAPSULE · ORAL

Approval history

2026-10-15Type 3 - New Dosage Form · Original · standard — Letter ↗AP