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DULOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS ELIZABETH · Approved 2013-12-17

Drug application

FDA Application #

ANDA090776

Application type

Abbreviated New Drug Application (Generic)

Brand name

DULOXETINE HYDROCHLORIDE

Generic name

DULOXETINE

Active ingredients

DULOXETINE HYDROCHLORIDE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS ELIZABETH

Manufacturer

Actavis Pharma, Inc.

First approval

2013-12-17

Source

Authoritative

Drugs@FDA application overview

Machine

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