← FDA Drug Approvals (Drugs@FDA)

TOPIRAMATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2024-07-11

Drug application

FDA Application #

ANDA215561

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

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2024-07-11

Source

Authoritative

Drugs@FDA application overview

Machine

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