← FDA Drug Approvals (Drugs@FDA)

PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2024-06-25

Drug application

FDA Application #

ANDA204982

Application type

Abbreviated New Drug Application (Generic)

Brand name

PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE

Generic name

PHENTERMINE AND TOPIRAMATE

Active ingredients

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS FL INC

Manufacturer

Teva Pharmaceuticals, Inc.

First approval

2024-06-25

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown