← FDA Drug Approvals (Drugs@FDA)

TOPIRAMATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2024-10-31

Drug application

FDA Application #

ANDA217795

Application type

Abbreviated New Drug Application (Generic)

Brand name

TOPIRAMATE

Generic name

TOPIRAMATE

Active ingredients

TOPIRAMATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2024-10-31

Source

Authoritative

Drugs@FDA application overview

Machine

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