FDA — authorised 21 July 1964
- Marketing authorisation holder: CREALTA PHARMS LLC
- Status: approved
🇺🇸 Oxandrin in United States
FDA authorised Oxandrin on 21 July 1964
Marketing authorisations
FDA — authorised 1 December 2006
- Application: ANDA076761
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: OXANDROLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 2006
- Application: ANDA076897
- Marketing authorisation holder: SANDOZ
- Local brand name: OXANDROLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2007
- Application: ANDA078033
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: OXANDROLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 2007
- Application: ANDA077827
- Marketing authorisation holder: PAR PHARM
- Local brand name: OXANDROLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 2007
- Application: ANDA077249
- Marketing authorisation holder: ROXANE
- Local brand name: OXANDROLONE
- Indication: TABLET — ORAL
- Status: approved
Oxandrin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Oxandrin approved in United States?
Yes. FDA authorised it on 21 July 1964; FDA authorised it on 1 December 2006; FDA authorised it on 1 December 2006.
Who is the marketing authorisation holder for Oxandrin in United States?
CREALTA PHARMS LLC holds the US marketing authorisation.