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ADDYI

NDA · New Drug Application · Sponsor: SPROUT PHARMS · Approved 2015-08-18

Drug application

FDA Application #

NDA022526

Application type

New Drug Application

Brand name

ADDYI

Generic name

FLIBANSERIN

Active ingredients

FLIBANSERIN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

SPROUT PHARMS

Manufacturer

Sprout Pharmaceuticals, Inc.

First approval

2015-08-18

Source

Authoritative

Drugs@FDA application overview

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