FDA — authorised 1 September 1977
- Application: NDA017831
- Marketing authorisation holder: APIL
- Local brand name: DIDRONEL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Etidronate in United States
FDA authorised Etidronate on 1 September 1977
Marketing authorisations
FDA — authorised 20 April 1987
- Application: NDA019545
- Marketing authorisation holder: MGI PHARMA INC
- Local brand name: DIDRONEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 January 2003
- Application: ANDA075800
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ETIDRONATE DISODIUM
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Etidronate approved in United States?
Yes. FDA authorised it on 1 September 1977; FDA authorised it on 20 April 1987; FDA authorised it on 24 January 2003.
Who is the marketing authorisation holder for Etidronate in United States?
APIL holds the US marketing authorisation.