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FDA Drug information

Felbamate

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


Effective Time

20231004

Version

5

Spl Product Data Elements

Felbamate Felbamate FELBAMATE FELBAMATE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE FD&C RED NO. 40 FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN OFF-WHITE TO PALE YELLOW COLOR CAPSULE 10;53 Felbamate Felbamate FELBAMATE FELBAMATE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE D&C YELLOW NO. 10 FD&C RED NO. 40 FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN LIGHT PINK TO PINK CAPSULE 10;54

Application Number

ANDA208970

Brand Name

Felbamate

Generic Name

Felbamate

Product Ndc

70771-1078

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1077-1 Felbamate tablets USP, 400 mg 100 Tablets Rx only NDC 70771-1078-1 Felbamate tablets USP, 600 mg 100 Tablets Rx only labels labels

Spl Medguide

SPL MEDGUIDE

Drug section

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