← FDA Drug Approvals (Drugs@FDA)

BACLOFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANDAS 5 HOLDING · Approved 2020-10-09

Drug application

FDA Application #

ANDA212378

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

ANDAS 5 HOLDING

Manufacturer

Method Pharmaceuticals LLC

First approval

2020-10-09

Source

Authoritative

Drugs@FDA application overview

Machine

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