FDA — authorised 19 August 1999
- Application: NDA020973
- Marketing authorisation holder: WAYLIS THERAP
- Status: supplemented
🇺🇸 Aciphex in United States
FDA authorised Aciphex on 19 August 1999
Marketing authorisations
FDA — authorised 8 November 2002
- Application: NDA021456
- Marketing authorisation holder: EISAI MEDCL RES
- Local brand name: ACIPHEX
- Indication: Tablet, Delayed Release — Oral
- Status: approved
FDA
- Status: approved
Aciphex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Aciphex approved in United States?
Yes. FDA authorised it on 19 August 1999; FDA authorised it on 8 November 2002; FDA has authorised it.
Who is the marketing authorisation holder for Aciphex in United States?
WAYLIS THERAP holds the US marketing authorisation.