FDA ANDA 205976 Approval Routing Summary (Endo)

Contents: Approval Routing Summary

Abbreviated New Drug Application (ANDA): 205976
Company: ENDO OPERATIONS
Drug Name: TOPIRAMATE
Active Ingredients: TOPIRAMATE
Dosage Form/Route: CAPSULE, EXTENDED RELEASE;ORAL
Marketing Status: Prescription
TE Code: AB1
Action Date: 05/04/2023