Drug application

TESTOSTERONE (TESTOSTERONE)

Drugs@FDA NDA 203098 · PERRIGO ISRAEL

Key facts

Drug name TESTOSTERONE
Active ingredients TESTOSTERONE
Application type NDA
Application number 203098
Company PERRIGO ISRAEL
Dosage forms GEL, METERED, TRANSDERMAL
Strength 12.5MG/1.25GM ACTUATION
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 3 - New Dosage Form
Latest submission status date Jan 31, 2013

At a glance

  • 1–9 Submissions
  • 1–9 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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