FDA — authorised 29 September 1995
- Application: NDA020560
- Marketing authorisation holder: ORGANON
- Local brand name: FOSAMAX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 alendronate in United States
FDA authorised alendronate on 29 September 1995
Marketing authorisations
FDA — authorised 6 February 2008
- Application: ANDA075710
- Marketing authorisation holder: IMPAX LABS INC
- Status: supplemented
FDA — authorised 4 August 2008
- Application: ANDA090124
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: supplemented
FDA — authorised 4 August 2008
- Application: ANDA076768
- Marketing authorisation holder: CIPLA
- Status: supplemented
FDA — authorised 25 February 2013
- Application: ANDA090520
- Marketing authorisation holder: HIKMA
- Status: supplemented
FDA — authorised 11 May 2023
- Application: ANDA214512
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA
- Status: approved
alendronate 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 alendronate approved in United States?
Yes. FDA authorised it on 29 September 1995; FDA authorised it on 6 February 2008; FDA authorised it on 4 August 2008.
Who is the marketing authorisation holder for alendronate in United States?
ORGANON holds the US marketing authorisation.