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OZOBAX DS

NDA · New Drug Application · Sponsor: METACEL PHARMS LLC · Approved 2019-09-18

Drug application

FDA Application #

NDA208193

Application type

New Drug Application

Brand name

OZOBAX DS

Generic name

BACLOFEN

Active ingredients

BACLOFEN

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

METACEL PHARMS LLC

Manufacturer

Palmetto Pharmaceuticals Inc.

First approval

2019-09-18

Source

Authoritative

Drugs@FDA application overview

Machine

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