MedPath
FDA Product

LACOSAMIDE

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

Basic Information

LACOSAMIDE

51407-723

Regulatory Information

51407-723

ANDA204921

C73584

February 8, 2024

USA

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

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

603184490

Active Ingredients

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 2165RE0K14

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LACOSAMIDE

Quantity: 150 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

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