FDA ANDA 215561 Approval Routing Summary for (Lupin)

Contents: Approval Routing Summary

Abbreviated New Drug Application (ANDA): 215561
Company: LUPIN LTD
Drug Name: TOPIRAMATE
Active Ingredients: TOPIRAMATE
Strength: 25MG
Dosage Form/Route: CAPSULE, EXTENDED RELEASE; ORAL
Marketing: Prescription
TE Code: AB1
RLD: No
RS: No