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PROVIGIL

NDA · New Drug Application · Sponsor: NUVO PHARMS · Approved 1998-12-24

Drug application

FDA Application #

NDA020717

Application type

New Drug Application

Brand name

PROVIGIL

Generic name

MODAFINIL

Active ingredients

MODAFINIL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NUVO PHARMS

Manufacturer

CIMA LABS INC.

First approval

1998-12-24

Source

Authoritative

Drugs@FDA application overview

Machine

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