← FDA Drug Approvals (Drugs@FDA)

DULOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2016-08-03

Drug application

FDA Application #

ANDA204343

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

HETERO LABS LTD III

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2016-08-03

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown