FDA — authorised 29 December 2010
- Application: NDA021463
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: FORTESTA
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
🇺🇸 Placebo Testosterone in United States
FDA authorised Placebo Testosterone on 29 December 2010
Marketing authorisations
FDA
- Status: approved
Placebo 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 approved in United States
Frequently asked questions
Is Placebo Testosterone approved in United States?
Yes. FDA authorised it on 29 December 2010; FDA has authorised it.
Who is the marketing authorisation holder for Placebo Testosterone in United States?
ENDO OPERATIONS holds the US marketing authorisation.