MedPath
FDA Product

Lacosamide

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

Basic Information

Lacosamide

14445-130

Regulatory Information

14445-130

ANDA208308

C73584

March 19, 2022

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

Human Prescription Drug Label

7

Company Information

650445950

Active Ingredients

LACOSAMIDE

Quantity: 100 mg in 1 1

Code: 563KS2PQY5

Class Code: ACTIB

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

POLYVINYL ALCOHOL

Code: 532B59J990

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

© Copyright 2025. All Rights Reserved by MedPath