FDA — authorised 20 February 2001
- Application: NDA021153
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NEXIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
🇺🇸 Esomeprazole Capsule in United States
FDA authorised Esomeprazole Capsule on 20 February 2001 · 13 US adverse-event reports
Marketing authorisations
FDA — authorised 20 October 2006
- Application: NDA021957
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NEXIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 27 February 2008
- Application: NDA022101
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NEXIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 January 2015
- Application: ANDA078003
- Marketing authorisation holder: CIPLA
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 3 August 2015
- Application: ANDA078936
- Marketing authorisation holder: MYLAN
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 25 September 2015
- Application: ANDA078279
- Marketing authorisation holder: DR REDDYS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 19 October 2015
- Application: ANDA203636
- Marketing authorisation holder: TORRENT
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 23 November 2015
- Application: NDA207920
- Marketing authorisation holder: ASTRAZENECA LP
- Local brand name: NEXIUM 24HR
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 April 2016
- Application: ANDA205606
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 18 August 2017
- Application: ANDA207193
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 1 September 2017
- Application: ANDA205563
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA209339
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 20 October 2017
- Application: ANDA208333
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 30 April 2018
- Application: ANDA209735
- Marketing authorisation holder: SUN PHARM
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 15 May 2018
- Application: ANDA207673
- Marketing authorisation holder: DR REDDYS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 May 2018
- Application: ANDA207265
- Marketing authorisation holder: HEC PHARM
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 5 March 2019
- Application: ANDA209202
- Marketing authorisation holder: P AND L
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA209647
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 10 May 2019
- Application: ANDA209495
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 22 May 2019
- Application: ANDA206296
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 5 June 2019
- Application: ANDA209716
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 16 October 2019
- Application: ANDA212376
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 February 2020
- Application: ANDA204206
- Marketing authorisation holder: DR REDDYS
- Local brand name: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 March 2020
- Application: ANDA211752
- Marketing authorisation holder: CIPLA
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 March 2020
- Application: ANDA211751
- Marketing authorisation holder: CIPLA
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 4 May 2020
- Application: ANDA212866
- Marketing authorisation holder: SUN PHARM
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 14 May 2020
- Application: ANDA211571
- Marketing authorisation holder: DR REDDYS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 May 2020
- Application: ANDA208939
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 2 June 2020
- Application: ANDA211977
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 2 June 2020
- Application: ANDA212507
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 June 2020
- Application: ANDA212088
- Marketing authorisation holder: MYLAN
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 22 September 2020
- Application: ANDA213158
- Marketing authorisation holder: CISEN
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 2 October 2020
- Application: ANDA212949
- Marketing authorisation holder: CSPC OUYI
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 18 November 2020
- Application: ANDA213859
- Marketing authorisation holder: GUANGZHOU NOVAKEN
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 26 February 2021
- Application: ANDA210559
- Marketing authorisation holder: INDCHEMIE HEALTH
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 19 March 2021
- Application: ANDA213486
- Marketing authorisation holder: GRAVITI PHARMS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 31 March 2021
- Application: ANDA090841
- Marketing authorisation holder: ETHYPHARM
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 20 July 2021
- Application: ANDA204920
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 August 2022
- Application: ANDA204470
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 October 2022
- Application: ANDA213699
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 March 2023
- Application: ANDA216149
- Marketing authorisation holder: GUARDIAN DRUG
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 March 2023
- Application: ANDA214920
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 7 June 2023
- Application: ANDA206055
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 12 July 2023
- Application: ANDA214473
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 11 October 2023
- Application: ANDA217738
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 October 2023
- Application: ANDA217427
- Marketing authorisation holder: GRANULES
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 27 December 2023
- Application: ANDA217022
- Marketing authorisation holder: ZHEJIANG YONGTAI
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 30 April 2024
- Application: ANDA207198
- Marketing authorisation holder: DR REDDYS
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 7 January 2025
- Application: ANDA217714
- Marketing authorisation holder: CIPLA
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA218948
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA219213
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ESOMEPRAZOLE MAGNESIUM
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA202461
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 13
Most-reported reactions
- Chronic Kidney Disease — 3 reports (23.08%)
- Renal Artery Stenosis — 2 reports (15.38%)
- Acute Kidney Injury — 1 report (7.69%)
- Hypertensive Nephropathy — 1 report (7.69%)
- Immune-Mediated Myositis — 1 report (7.69%)
- Ischaemic Nephropathy — 1 report (7.69%)
- Myocarditis — 1 report (7.69%)
- Nocturia — 1 report (7.69%)
- Pyelonephritis — 1 report (7.69%)
- Renal Atrophy — 1 report (7.69%)
Esomeprazole Capsule 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 Esomeprazole Capsule approved in United States?
Yes. FDA authorised it on 20 February 2001; FDA authorised it on 20 October 2006; FDA authorised it on 27 February 2008.
Who is the marketing authorisation holder for Esomeprazole Capsule in United States?
ASTRAZENECA holds the US marketing authorisation.