Orange Book product · Brand (NDA)

SARAFEM

FLUOXETINE HYDROCHLORIDE

Brand (NDA)NDA 021860DISCN APIL

View FLUOXETINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

May 19, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
May 19, 2006
20 yr 5 mo ago
Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 021860

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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