← FDA Drug Approvals (Drugs@FDA)

BACLOFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2018-11-23

Drug application

FDA Application #

ANDA211659

Application type

Abbreviated New Drug Application (Generic)

Brand name

BACLOFEN

Generic name

BACLOFEN

Active ingredients

BACLOFEN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS LIFESCIENCES

Manufacturer

Zydus Pharmaceuticals (USA) Inc.

First approval

2018-11-23

Source

Authoritative

Drugs@FDA application overview

Machine

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