Drug application

ELIGARD KIT (LEUPROLIDE ACETATE)

Drugs@FDA NDA 021731 · TOLMAR

Key facts

Drug name ELIGARD KIT
Active ingredients LEUPROLIDE ACETATE
Application type NDA
Application number 021731
Company TOLMAR
Dosage forms POWDER, SUBCUTANEOUS
Strength 45MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Dec 14, 2004

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No 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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