FDA — authorised 12 October 1993
- Application: NDA019762
- Marketing authorisation holder: ALZA
- Local brand name: TESTODERM
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
🇺🇸 therapeutic testosterone in United States
FDA authorised therapeutic testosterone on 12 October 1993
Marketing authorisation
therapeutic testosterone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Endocrinology / Oncology approved in United States
Frequently asked questions
Is therapeutic testosterone approved in United States?
Yes. FDA authorised it on 12 October 1993.
Who is the marketing authorisation holder for therapeutic testosterone in United States?
ALZA holds the US marketing authorisation.