MedPath
FDA Product

Lacosamide

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

Basic Information

Lacosamide

47335-922

Regulatory Information

47335-922

ANDA205031

C73584

November 20, 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, for oral use, CV Initial U.S. Approval: 2008

Human Prescription Drug Label

12

Company Information

146974886

Active Ingredients

LACOSAMIDE

Quantity: 100 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 2165RE0K14

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)

Code: UKE75GEA7F

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

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