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FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2016-08-19

Drug application

FDA Application #

ANDA203836

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOXETINE HYDROCHLORIDE

Generic name

FLUOXETINE HYDROCHLORIDE

Active ingredients

FLUOXETINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

PH HEALTH

Manufacturer

Endo USA, Inc.

First approval

2016-08-19

Source

Authoritative

Drugs@FDA application overview

Machine

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