FDA — authorised 27 July 2022
- Application: NDA213953
- Marketing authorisation holder: MARIUS
- Local brand name: KYZATREX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Oral Testosterone Undecanoate in United States
FDA authorised Oral Testosterone Undecanoate on 27 July 2022
Marketing authorisations
FDA
- Application: ANDA207583
- Marketing authorisation holder: HIKMA PHARMACEUTICALS USA INC
- Local brand name: TESTOSTERONE UNDECANOATE
- Indication: INJECTABLE — INTRAMUSCULAR
- Status: approved
Other Endocrinology approved in United States
Frequently asked questions
Is Oral Testosterone Undecanoate approved in United States?
Yes. FDA authorised it on 27 July 2022; FDA has authorised it.
Who is the marketing authorisation holder for Oral Testosterone Undecanoate in United States?
MARIUS holds the US marketing authorisation.