Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsTRANSDERMALGeneric

FORTESTA

TESTOSTERONE

Standard Dose
10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview FORTESTA is listed in Drugs@FDA under application 021463 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient TESTOSTERONE Form and strength GEL, METERED;TRANSDERMAL - 10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ENDO OPERATIONS Submission history Latest submission status date: 2025-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview FORTESTA is listed in Drugs@FDA under application 021463 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TESTOSTERONE Form and strength GEL, METERED;TRANSDERMAL - 10MG/0.5GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ENDO OPERATIONS Submission history Latest submission status date: 2025-07-11 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.