MedPath
FDA Product

Metaxalone

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Metaxalone

33261-724

Regulatory Information

33261-724

ANDA203399

C73584

January 13, 2014

USA

Metaxalone Tablets

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

801503249

Active Ingredients

METAXALONE

Quantity: 800 mg in 1 1

Code: 1NMA9J598Y

Class Code: ACTIB

CALCIUM CARBONATE

Code: H0G9379FGK

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POVIDONES

Code: FZ989GH94E

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

METAXALONE

Code: 1NMA9J598Y

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