FDA — authorised 30 June 2017
- Application: NDA209463
- Marketing authorisation holder: HIKMA
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Protonix in United States
FDA authorised Protonix on 30 June 2017
Marketing authorisations
FDA — authorised 30 August 2021
- Application: ANDA209524
- Marketing authorisation holder: HANGZHOU ZHONGMEI
- Status: approved
FDA — authorised 29 August 2022
- Application: ANDA215860
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 27 September 2022
- Application: ANDA213725
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 16 June 2023
- Application: ANDA216247
- Marketing authorisation holder: DEXCEL
- Status: approved
Protonix 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 Protonix approved in United States?
Yes. FDA authorised it on 30 June 2017; FDA authorised it on 30 August 2021; FDA authorised it on 29 August 2022.
Who is the marketing authorisation holder for Protonix in United States?
HIKMA holds the US marketing authorisation.