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FDA Drug information

Lamotrigine

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Effective Time

20230926

Version

10

Spl Product Data Elements

Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;79 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;90 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;80 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;81 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;82 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;91 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE BLACK CURRANT WHITE TO OFF- WHITE Black Current ROUND Z;13 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE BLACK CURRANT WHITE TO OFF- WHITE Black Current ROUND Z;12

Application Number

ANDA078009

Brand Name

Lamotrigine

Generic Name

Lamotrigine

Product Ndc

65841-689

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lamotrigine Tablets (Chewable, Dispersible), 5 mg NDC 65841-689-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets (Chewable, Dispersible), 5 mg Lamotrigine Tablets (Chewable, Dispersible), 25 mg NDC 65841-690-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets (Chewable, Dispersible), 25 mg Lamotrigine Tablets USP, 25 mg NDC 65841-682-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 25 mg Lamotrigine Tablets USP, 50 mg NDC 65841-683-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 50 mg Lamotrigine Tablets USP, 100 mg NDC 65841-684-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 100 mg Lamotrigine Tablets USP, 150 mg NDC 65841-685-14 in bottle of 60 tablets 60 tablets Rx only Lamotrigine Tablets USP, 150 mg Lamotrigine Tablets USP, 200 mg NDC 65841-686-14 in bottle of 60 tablets 60 tablets Rx only Lamotrigine Tablets USP, 200 mg Lamotrigine Tablets USP, 250 mg NDC 65841-687-05 in bottle of 500 tablets 500 tablets Rx only Lamotrigine Tablets USP, 250 mg Lamotrigine Tablets (Chewable, Dispersible), 5 mg Lamotrigine Tablets (Chewable, Dispersible), 5mg Lamotrigine Tablets (Chewable, Dispersible), 25 mg Lamotrigine Tablets USP, 25 mg Lamotrigine Tablets USP, 50 mg Lamotrigine Tablets USP, 100 mg Lamotrigine Tablets USP, 150 mg Lamotrigine Tablets USP, 200 mg Lamotrigine Tablets USP, 250 mg

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