Gablofen

Product NDC

45945-157

11-digit product format

459450157

Labeler code

45945

Product ID

45945-157_5b051c22-c1c9-484c-969b-1c20e07e6c05

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

baclofen

Dosage form

INJECTION

Route

INTRATHECAL

Labeler

Mallinckrodt Inc (Brand Pharmaceuticals)

Application

NDA022462

Marketing category

NDA

Marketing start

2010-11-19

Marketing end

2020-01-31

Substance

BACLOFEN

Active strength

2000 ug/mL

Pharmacologic classes

GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record