FDA — authorised 2 August 2007
- Application: ANDA077056
- Marketing authorisation holder: TEVA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Protonix in United States
FDA authorised Protonix on 2 August 2007
Marketing authorisations
FDA — authorised 10 September 2007
- Application: ANDA077058
- Marketing authorisation holder: SUN PHARM
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 19 January 2011
- Application: ANDA077619
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 19 January 2011
- Application: ANDA091231
- Marketing authorisation holder: APOTEX
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 20 January 2011
- Application: ANDA078281
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 7 February 2011
- Application: ANDA090797
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 August 2011
- Application: ANDA090901
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 16 February 2012
- Application: ANDA200821
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 2 May 2012
- Application: ANDA200794
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 8 November 2012
- Application: ANDA079197
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 September 2014
- Application: ANDA202882
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 January 2016
- Application: ANDA205119
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 March 2016
- Application: ANDA205675
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 30 June 2017
- Application: NDA209463
- Marketing authorisation holder: HIKMA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2018
- Application: ANDA208580
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 August 2019
- Application: ANDA077674
- Marketing authorisation holder: SUN PHARM
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 May 2022
- Application: ANDA204400
- Marketing authorisation holder: GLAND
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 May 2022
- Application: ANDA216171
- Marketing authorisation holder: BE PHARMS
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 9 February 2023
- Application: ANDA217416
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 27 October 2023
- Application: ANDA216139
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 11 December 2023
- Application: ANDA217282
- Marketing authorisation holder: GRANULES
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 14 February 2024
- Application: NDA217512
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 1 August 2024
- Application: ANDA216021
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 31 March 2025
- Application: ANDA217923
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 31 March 2025
- Application: ANDA219230
- Marketing authorisation holder: ALEMBIC
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 March 2025
- Application: ANDA217458
- Marketing authorisation holder: CIPLA
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 22 April 2026
- Application: ANDA219973
- Marketing authorisation holder: SHUANGCHENG
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
The FDA approved Protonix (Pantoprazole Sodium) for intravenous use on 22 April 2026. This approval was granted to SHUANGCHENG under the standard expedited pathway. Protonix is indicated for use in the United States.
FDA
- Application: NDA022226
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: PANTOPRAZOLE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- 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.
Frequently asked questions
Is Protonix approved in United States?
Yes. FDA authorised it on 2 August 2007; FDA authorised it on 10 September 2007; FDA authorised it on 19 January 2011.
Who is the marketing authorisation holder for Protonix in United States?
TEVA holds the US marketing authorisation.