← FDA Drug Approvals (Drugs@FDA)

TOPIRAMATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2026-01-12

Drug application

FDA Application #

ANDA217443

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOPIRAMATE

Generic name

TOPIRAMATE

Active ingredients

TOPIRAMATE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ASCENT PHARMS INC

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2026-01-12

Source

Authoritative

Drugs@FDA application overview

Machine

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