FDA — authorised 10 January 1967
- Marketing authorisation holder: ATON
- Status: approved
🇺🇸 Edecrin in United States
FDA authorised Edecrin on 10 January 1967
Marketing authorisations
FDA — authorised 10 January 1967
- Application: NDA016092
- Marketing authorisation holder: BAUSCH
- Local brand name: EDECRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1967
- Application: NDA016093
- Marketing authorisation holder: BAUSCH
- Local brand name: EDECRIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 2016
- Application: ANDA205609
- Marketing authorisation holder: ADAPTIS
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2017
- Application: ANDA207262
- Marketing authorisation holder: HIKMA
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA208501
- Marketing authorisation holder: PH HEALTH
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 2018
- Application: ANDA208805
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 July 2018
- Application: ANDA205709
- Marketing authorisation holder: ALVOGEN
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2019
- Application: ANDA211809
- Marketing authorisation holder: AGNITIO
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2019
- Application: ANDA211232
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA211719
- Marketing authorisation holder: LUPIN
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 February 2020
- Application: ANDA212417
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 October 2020
- Application: ANDA213240
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ETHACRYNIC ACID
- Indication: TABLET — ORAL
- Status: approved
Edecrin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Edecrin approved in United States?
Yes. FDA authorised it on 10 January 1967; FDA authorised it on 10 January 1967; FDA authorised it on 10 January 1967.
Who is the marketing authorisation holder for Edecrin in United States?
ATON holds the US marketing authorisation.