← FDA Drug Approvals (Drugs@FDA)

BACLOFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2016-05-03

Drug application

FDA Application #

ANDA091193

Application type

Abbreviated New Drug Application (Generic)

Brand name

BACLOFEN

Generic name

Baclofen

Active ingredients

BACLOFEN

Dosage form

INJECTABLE

Route

INTRATHECAL

Marketing status

Prescription

Sponsor

AMNEAL

First approval

2016-05-03

Source

Authoritative

Drugs@FDA application overview

Machine

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