MedPath
FDA Product

Lacosamide

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

Basic Information

Lacosamide

59651-016

Regulatory Information

59651-016

ANDA209224

C73584

January 25, 2024

USA

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

Human Prescription Drug Label

1

Company Information

650082092

Active Ingredients

ACESULFAME POTASSIUM

Code: 23OV73Q5G9

Class Code: IACT

LACOSAMIDE

Quantity: 10 mg in 1 mL

Code: 563KS2PQY5

Class Code: ACTIB

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

Code: K679OBS311

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

NONCRYSTALLIZING SORBITOL SOLUTION

Code: 9E0S3UM200

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

ACESULFAME

Code: MA3UYZ6K1H

Class Code: IACT

AMMONIUM GLYCYRRHIZATE

Code: 3VRD35U26C

Class Code: IACT

ASPARTAME

Code: Z0H242BBR1

Class Code: IACT

Active Moieties

LACOSAMIDE

Code: 563KS2PQY5

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