FDA — authorised 22 November 2002
- Application: NDA021498
- Marketing authorisation holder: ROMARK
- Local brand name: ALINIA
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Alinia in United States
FDA authorised Alinia on 22 November 2002
Marketing authorisations
FDA — authorised 22 November 2002
- Marketing authorisation holder: ROMARK
- Status: approved
FDA — authorised 21 July 2004
- Application: NDA021497
- Marketing authorisation holder: ROMARK
- Local brand name: ALINIA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2005
- Application: NDA021818
- Marketing authorisation holder: ROMARK
- Local brand name: ALINIA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2020
- Application: ANDA213820
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 3 February 2025
- Application: ANDA214844
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NITAZOXANIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA218701
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: NITAZOXANIDE
- Indication: TABLET — ORAL
- Status: approved
Alinia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Alinia approved in United States?
Yes. FDA authorised it on 22 November 2002; FDA authorised it on 22 November 2002; FDA authorised it on 21 July 2004.
Who is the marketing authorisation holder for Alinia in United States?
ROMARK holds the US marketing authorisation.