TOPIRAMATE
Summary
FDA approved TOPIRAMATE by AMTA. ANDA (Generic) approval (Labeling) on 2025-07-01. CAPSULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA218695-1
Action Date
2025-07-01
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
TOPIRAMATE, CAPSULE, EXTENDED RELEASE, ORAL. Application: ANDA218695
Company
Context & Analysis
AMTA has 2 FDA actions in our database.
Frequently Asked Questions
How often does AMTA have FDA actions?
AMTA has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA218695-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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