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MODAFINIL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APPCO · Approved 2017-08-16

Drug application

FDA Application #

ANDA207196

Application type

Abbreviated New Drug Application (Generic)

Brand name

MODAFINIL

Generic name

MODAFINIL

Active ingredients

MODAFINIL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

APPCO

Manufacturer

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

First approval

2017-08-16

Source

Authoritative

Drugs@FDA application overview

Machine

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