MedPath
FDA Product

LACOSAMIDE

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

Basic Information

LACOSAMIDE

50228-192

Regulatory Information

50228-192

ANDA205237

C73584

January 9, 2023

USA

These highlights do not include all the information needed to use LACOSAMIDE TABLETS safely and effectively. See full prescribing information for LACOSAMIDE TABLETS . LACOSAMIDE tablets, film coated tablet, for oral use, CV Initial U.S. Approval: 2008

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

079391286

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

LACOSAMIDE

Quantity: 50 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

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