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SARAFEM

NDA · New Drug Application · Sponsor: APIL · Approved 2006-05-19

Drug application

FDA Application #

NDA021860

Application type

New Drug Application

Brand name

SARAFEM

Generic name

Fluoxetine Hydrochloride

Active ingredients

FLUOXETINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

APIL

First approval

2006-05-19

Source

Authoritative

Drugs@FDA application overview

Machine

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