FDA — authorised 19 August 1999
- Marketing authorisation holder: EISAI INC
- Status: approved
🇺🇸 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 — authorised 18 November 2015
- Application: ANDA204237
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 1 February 2019
- Application: ANDA205761
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Indication: Labeling
- Status: approved
FDA — authorised 7 February 2019
- Application: ANDA090678
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
FDA — authorised 15 November 2019
- Application: ANDA204179
- Marketing authorisation holder: AMNEAL PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 2 September 2022
- Application: ANDA202376
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- 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 Metabolic 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 authorised it on 18 November 2015.
Who is the marketing authorisation holder for Aciphex in United States?
EISAI INC holds the US marketing authorisation.