← FDA Drug Approvals (Drugs@FDA)

BACLOFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MAIA PHARMS INC · Approved 2021-01-15

Drug application

FDA Application #

ANDA210777

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

MAIA PHARMS INC

Manufacturer

MAlA Pharmaceuticals, Inc.

First approval

2021-01-15

Source

Authoritative

Drugs@FDA application overview

Machine

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