← FDA Drug Approvals (Drugs@FDA)

METAXALONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2017-06-15

Drug application

FDA Application #

ANDA203695

Application type

Abbreviated New Drug Application (Generic)

Brand name

METAXALONE

Generic name

METAXALONE

Active ingredients

METAXALONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS FL INC

Manufacturer

Actavis Pharma, Inc.

First approval

2017-06-15

Source

Authoritative

Drugs@FDA application overview

Machine

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