MedPath
FDA Product

lacosamide

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

Basic Information

lacosamide

68462-680

Regulatory Information

68462-680

ANDA205006

C73584

November 14, 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

4

Company Information

130597813

Active Ingredients

HYDROXYPROPYL CELLULOSE (110000 WAMW)

Code: 5Y0974F5PW

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LACOSAMIDE

Quantity: 150 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

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

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

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