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DULOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BRECKENRIDGE · Approved 2014-06-11

Drug application

FDA Application #

ANDA203088

Application type

Abbreviated New Drug Application (Generic)

Brand name

DULOXETINE HYDROCHLORIDE

Generic name

DULOXETINE HYDROCHLORIDE

Active ingredients

DULOXETINE HYDROCHLORIDE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

BRECKENRIDGE

Manufacturer

Breckenridge Pharmaceutical, Inc.

First approval

2014-06-11

Source

Authoritative

Drugs@FDA application overview

Machine

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