Orange Book product · Brand (NDA)

EULEXIN

FLUTAMIDE

Brand (NDA)NDA 018554DISCN SCHERING

View FLUTAMIDE family Open on FDA Orange Book

At a glance

Jan 27, 1989

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jan 27, 1989
37 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

FLUTAMIDE

Strength

125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 018554

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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