← FDA Drug Approvals (Drugs@FDA)

FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2017-11-16

Drug application

FDA Application #

ANDA209419

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOXETINE HYDROCHLORIDE

Generic name

FLUOXETINE

Active ingredients

FLUOXETINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

PH HEALTH

Manufacturer

Endo USA, Inc.

First approval

2017-11-16

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown