← FDA Drug Approvals (Drugs@FDA)

BACLOFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2021-07-16

Drug application

FDA Application #

ANDA214114

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

REGCON HOLDINGS

First approval

2021-07-16

Source

Authoritative

Drugs@FDA application overview

Machine

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