Drug application

VIADUR (LEUPROLIDE ACETATE)

Drugs@FDA NDA 021088 · ORTHO MCNEIL JANSSEN

Key facts

Drug name VIADUR
Active ingredients LEUPROLIDE ACETATE
Application type NDA
Application number 021088
Company ORTHO MCNEIL JANSSEN
Dosage forms IMPLANT, IMPLANTATION
Strength EQ 65MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 3 - New Dosage Form
Latest submission status date Mar 3, 2000

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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