← FDA Drug Approvals (Drugs@FDA)

TOPIRAMATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM LABS LTD · Approved 2009-03-27

Drug application

FDA Application #

ANDA090162

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOPIRAMATE

Generic name

TOPIRAMATE

Active ingredients

TOPIRAMATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

UNICHEM LABS LTD

Manufacturer

Unichem Pharmaceuticals (USA), Inc.

First approval

2009-03-27

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown