FDA — authorised 29 September 1995
- Application: NDA020560
- Marketing authorisation holder: ORGANON
- Local brand name: FOSAMAX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 teriparatide and alendronate in United States
FDA authorised teriparatide and alendronate on 29 September 1995
Marketing authorisations
FDA — authorised 17 September 2003
- Application: NDA021575
- Marketing authorisation holder: MERCK
- Local brand name: FOSAMAX
- Indication: SOLUTION — ORAL
- Status: approved
Other Bone metabolism / Osteoporosis approved in United States
Frequently asked questions
Is teriparatide and alendronate approved in United States?
Yes. FDA authorised it on 29 September 1995; FDA authorised it on 17 September 2003.
Who is the marketing authorisation holder for teriparatide and alendronate in United States?
ORGANON holds the US marketing authorisation.