FDA — authorised 5 October 2007
- Application: ANDA077132
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Actonel® in United States
FDA authorised Actonel® on 5 October 2007
Marketing authorisations
FDA — authorised 10 June 2014
- Application: ANDA090886
- Marketing authorisation holder: SUN PHARM
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2014
- Application: ANDA090877
- Marketing authorisation holder: APOTEX
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2014
- Application: ANDA079215
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 2015
- Application: ANDA203217
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA206768
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA205066
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 February 2019
- Application: ANDA207516
- Marketing authorisation holder: HANGZHOU BINJIANG
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2019
- Application: ANDA205280
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2019
- Application: ANDA203925
- Marketing authorisation holder: SUN PHARM
- Local brand name: RISEDRONATE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Actonel® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Actonel® approved in United States?
Yes. FDA authorised it on 5 October 2007; FDA authorised it on 10 June 2014; FDA authorised it on 10 June 2014.
Who is the marketing authorisation holder for Actonel® in United States?
TEVA PHARMS USA holds the US marketing authorisation.