← FDA Drug Approvals (Drugs@FDA)

BACLOFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MAIA PHARMS INC · Approved 2019-07-30

Drug application

FDA Application #

ANDA210315

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

Sagent Pharmaceuticals

First approval

2019-07-30

Source

Authoritative

Drugs@FDA application overview

Machine

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