FDA — authorised 9 February 2000
- Application: NDA021107
- Marketing authorisation holder: LEGACY PHARMA
- Status: supplemented
🇺🇸 ALOSETRON HYDROCHLORIDE in United States
FDA authorised ALOSETRON HYDROCHLORIDE on 9 February 2000
Marketing authorisations
FDA — authorised 22 December 2016
- Application: ANDA206647
- Marketing authorisation holder: AMNEAL PHARMS
- Status: supplemented
FDA — authorised 23 February 2018
- Application: ANDA206113
- Marketing authorisation holder: PH HEALTH
- Local brand name: ALOSETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2019
- Application: ANDA209180
- Marketing authorisation holder: RISING
- Local brand name: ALOSETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 2019
- Application: ANDA211621
- Marketing authorisation holder: HIBROW HLTHCARE
- Status: supplemented
FDA — authorised 9 September 2020
- Application: ANDA213614
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: ALOSETRON HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
ALOSETRON HYDROCHLORIDE 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 ALOSETRON HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 9 February 2000; FDA authorised it on 22 December 2016; FDA authorised it on 23 February 2018.
Who is the marketing authorisation holder for ALOSETRON HYDROCHLORIDE in United States?
LEGACY PHARMA holds the US marketing authorisation.