Orange Book product · Brand (NDA)

PROZAC

FLUOXETINE HYDROCHLORIDE

Brand (NDA)NDA 018936DISCN ELI LILLY AND CO

View FLUOXETINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Dec 23, 1992

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 23, 1992
34 yr ago
Today

Pharmaceutical detail

Active ingredient

FLUOXETINE HYDROCHLORIDE

Strength

EQ 10MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 018936

Product number

006

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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