FDA ANDA 217248 Approval Routing Summary (Alkem Labs)

Approval Routing Summary for ANDA 217248 (Alkem Labs).

Abbreviated New Drug Application (ANDA): 217248
Company: ALKEM LABS LTD
Drug Name: TOPIRAMATE
Active Ingredients: TOPIRAMATE
Strength: 25MG
Dosage Form/Route: CAPSULE, EXTENDED RELEASE;ORAL
Marketing Status: Prescription
TE Code: AB1
RLD: NO
RS: NO