RecallHawk

TROKENDI XR (TOPIRAMATE)

SUPERNUS PHARMS

Summary

FDA approved TROKENDI XR (TOPIRAMATE) by SUPERNUS PHARMS. NDA (New Drug) approval (Labeling) on 2026-03-06. CAPSULE, EXTENDED RELEASE, ORAL.

Details

Source

Drug Approval

External ID

NDA201635-39

Action Date

2026-03-06

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

TROKENDI XR (generic: TOPIRAMATE), CAPSULE, EXTENDED RELEASE, ORAL. Application: NDA201635

Context & Analysis

SUPERNUS PHARMS has 2 FDA actions in our database.

Frequently Asked Questions

How often does SUPERNUS PHARMS have FDA actions?

SUPERNUS PHARMS 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 "NDA201635-39" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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