Assyro AI

Orange Book product · Brand (NDA)

VIADUR

LEUPROLIDE ACETATE

Brand (NDA)NDA 021088DISCN ORTHO MCNEIL JANSSEN
View LEUPROLIDE ACETATE familyOpen on FDA Orange Book

At a glance

Mar 03, 2000

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 03, 2000

    26 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEUPROLIDE ACETATE

Strength

EQ 65MG BASE

Dosage form

IMPLANT

Route

IMPLANTATION

TE code

Not listed

Application

NDA 021088

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo