FDA — authorised 26 August 1977
- Status: approved
🇺🇸 Amrix in United States
FDA authorised Amrix on 26 August 1977
Marketing authorisations
FDA — authorised 3 February 2006
- Application: ANDA071611
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Indication: Labeling
- Status: approved
FDA — authorised 1 February 2007
- Application: NDA021777
- Marketing authorisation holder: TEVA PHARMS INTL
- Local brand name: AMRIX
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 August 2008
- Application: ANDA077797
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 13 March 2018
- Application: ANDA091281
- Marketing authorisation holder: TWI PHARMS INC
- Indication: Bioequivalence
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA213324
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 22 July 2024
- Application: ANDA207314
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Amrix in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Amrix approved in United States?
Yes. FDA authorised it on 26 August 1977; FDA authorised it on 3 February 2006; FDA authorised it on 1 February 2007.
Who is the marketing authorisation holder for Amrix in United States?
Marketing authorisation holder not available in our data.