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FDA ANDA 217248 Approval Routing Summary (Alkem Labs)

FDA ANDA 217248 Approval Routing Summary (Alkem Labs)

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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

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