Drug application

TOPIRAMATE (TOPIRAMATE)

Drugs@FDA ANDA 208949 · ZYDUS

Key facts

Drug name TOPIRAMATE
Active ingredients TOPIRAMATE
Application type ANDA
Application number 208949
Company ZYDUS
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 25MG
Marketing status Prescription
TE codes AB2
Reference listed drug No
Latest submission status date Nov 28, 2022

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

Browse all Drugs@FDA applications