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FDA Drug information

Lacosamide

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20220421

Version

2

Spl Product Data Elements

lacosamide lacosamide LACOSAMIDE LACOSAMIDE CROSPOVIDONE (120 .MU.M) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE FD&C BLUE NO. 2 FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE 11 lacosamide lacosamide LACOSAMIDE LACOSAMIDE CROSPOVIDONE (120 .MU.M) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (1600000 WAMW) LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE 12 lacosamide lacosamide LACOSAMIDE LACOSAMIDE CROSPOVIDONE (120 .MU.M) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE tan 113 lacosamide lacosamide LACOSAMIDE LACOSAMIDE CROSPOVIDONE (120 .MU.M) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE FD&C BLUE NO. 2 HYDROXYPROPYL CELLULOSE (1600000 WAMW) LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE TALC TITANIUM DIOXIDE 114

Application Number

ANDA204921

Brand Name

Lacosamide

Generic Name

lacosamide

Product Ndc

69539-028

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69539-025-60 Lacosamide Tablet, USP 50 mg Rx Only PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT 60 Tablets NDC 69539-026-60 Lacosamide Tablet, USP 100 mg Rx Only PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT 60 Tablets NDC 69539-027-60 Lacosamide Tablet, USP 150 mg Rx Only PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT 60 Tablets NDC 69539-028-60 Lacosamide Tablet, USP 200 mg Rx Only PHARMACIST: DISPENSE WITH THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT 60 Tablets lacosamide-50mg-60s-count lacosamide-100mg-60s-count lacosamide-150mg-60s-count lacosamide-200mg-60s-count

Drug section

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