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FDA Drug information

Modafinil

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


Effective Time

20231004

Version

5

Spl Product Data Elements

Modafinil Modafinil MODAFINIL MODAFINIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE STARCH, CORN OFF-WHITE CAPSULE 1072 Modafinil Modafinil MODAFINIL MODAFINIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE STARCH, CORN OFF-WHITE CAPSULE 10;73

Application Number

ANDA209966

Brand Name

Modafinil

Generic Name

Modafinil

Product Ndc

70771-1051

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1051-3 Modafinil Tablets USP, 100 mg 30 Tablets Rx only NDC 70771-1052-3 Modafinil Tablets USP, 200 mg 30 Tablets Rx only Modafinil Tablets USP, 100mg and 200mg Modafinil Tablets USP, 100mg and 200mg

Spl Medguide

SPL MEDGUIDE

Drug section

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