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FLUOXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL MOLECULAR · Approved 2004-05-14

Drug application

FDA Application #

ANDA076458

Application type

Abbreviated New Drug Application (Generic)

Brand name

FLUOXETINE HYDROCHLORIDE

Generic name

FLUOXETINE

Active ingredients

FLUOXETINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Discontinued

Sponsor

CHARTWELL MOLECULAR

Manufacturer

Chartwell Governmental & Specialty RX, LLC

First approval

2004-05-14

Source

Authoritative

Drugs@FDA application overview

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