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  • CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE
  • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
  • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE
  • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
  • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET
  • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET
  • FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
  • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217022

FDA
27 Dec 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-29-2023-18805.pdf

FDA
29 Nov 2023

https://www.business-standard.com/companies/news/zydus-receives-final-approval-from-usfda-for-esomeprazole-magnesium-123060800613_1.html

BUSINESS STANDARD
09 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206055

FDA
07 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213699

FDA
06 Oct 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-5-2022-44974.pdf

FDA
05 Oct 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-18-2022-1653024384.pdf

FDA
19 May 2022

https://psnc.org.uk/our-news/june-2021-price-concessions-1st-update/

PSNC
18 Jun 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-6-2021-1609918562.pdf

FDA
06 Jan 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213859

FDA
27 Nov 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212949

FDA
02 Oct 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213158

FDA
25 Sep 2020

https://psnc.org.uk/our-news/medicine-supply-notification-esomeprazole-40mg-iv-powder-for-solution-grunenthal-ranbaxy-tilomed/

PSNC
18 Sep 2020

http://pharmabiz.com/NewsDetails.aspx?aid=129544&sid=2

PHARMABIZ
13 Jul 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212088

FDA
30 Jun 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212507

FDA
06 Jun 2020

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-to-recall-1752-bottles-of-heartburn-drug-in-the-us/articleshow/75656114.cms

ECONOMICTIMES
11 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212866

FDA
06 May 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-6-2020-1588742806.pdf

FDA
06 May 2020

https://www.biospectrumindia.com/news/43/15876/dr-reddys-laboratories-launches-delayed-release-tablets-in-the-u-s-market.html

BIOSPECTRUMINDIA
26 Mar 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211752

FDA
26 Mar 2020

https://business.medicaldialogues.in/pharma-news/dr-reddys-laboratories-launches-generic-of-naproxen-esomeprazole-magnesium-delayed-release-tablets-63539

BUSINESS
29 Feb 2020

https://www.businesswire.com/news/home/20200227005345/en

BUSINESSWIRE
27 Feb 2020

https://www.biospace.com/article/releases/dr-reddy-s-laboratories-announces-the-first-generic-launch-of-naproxen-and-esomeprazole-magnesium-delayed-release-tablets-in-the-u-s-market/

BIOSPECTRUMINDIA
27 Feb 2020

https://www.business-standard.com/article/pti-stories/sun-pharma-gets-partial-relief-from-us-court-in-litigation-involving-three-generic-drugs-119120200818_1.html

BUSINESS-STANDARD
03 Dec 2019

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/now-antacids-must-carry-kidney-injury-warning/articleshow/71933520.cms

ECONOMICTIMES
08 Nov 2019

https://www.pharmacompass.com/pdf/news/union-quimico-farmaceutica-fails-edqm-inspection-1572404101.pdf

EDQM
29 Oct 2019

https://www.fiercepharma.com/manufacturing/need-a-safe-antacid-for-heartburn-fda-declares-pepcid-nexium-and-others-free-ndma

Eric Palmer FIERCE PHARMA
24 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212376

FDA
18 Oct 2019

https://www.raps.org/news-and-articles/news-articles/2019/9/product-hopping-ec-hearing-addresses-restriction

Z. Brennan RAPS
19 Sep 2019

https://pharmaphorum.com/news/az-says-recovery-to-continue-to-despite-patent-expiry-and-brexit-headwinds/

PHARMAPHORUM
25 Jul 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209716

FDA
05 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206296

FDA
24 May 2019

http://www.pharmabiz.com/NewsDetails.aspx?aid=115936&sid=2

PHARMABIZ
22 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209495

FDA
16 May 2019

https://www.business-standard.com/article/pti-stories/glenmark-pharma-gets-usfda-nod-for-acid-reflux-medication-119051400237_1.html

BUSINESS-STANDARD
13 May 2019

http://pharmabiz.com/ArticleDetails.aspx?aid=115527&sid=1

PHARMABIZ
06 May 2019

https://www.pharmaceutical-technology.com/downloads/whitepapers/materials/polpharma-finished-dosage-formulation-dossier-development/#polpharma

PHARMACEUTICAL-TECHNOLOGY
19 Mar 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204920

FDA
23 Feb 2019

https://www.pharmacompass.com/pdf/news/Enforcement-Report-for-Week-of-February-20-2019-1550644123.pdf

FDA
20 Feb 2019

https://www.thehindubusinessline.com/companies/zydus-cadila-gets-tentative-usfda-nod-for-generic-acid-reflux-drug/article26050807.ece

HINDU BUSINESS LINE
22 Jan 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204206

FDA
28 Dec 2018

https://www.forbes.com/sites/matthewherper/2018/12/19/glaxo-and-pfizer-raise-the-question-should-drug-companies-sell-toothpaste-and-chapstick/?utm_source=newsletter&utm_medium=email&utm_campaign=innovationrx#b61045d235ed

Matthew Herper FORBES
20 Dec 2018

https://insight.rpxcorp.com/litigation_documents/13139395

PATENT LITIGATION
24 Nov 2018

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM293268.pdf

FDA
01 Nov 2018

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-nexium-21957-esomeprazole-magnesium-delayed-release-for-oral-suspension-1541063315.pdf

FDA
01 Nov 2018

https://endpts.com/astrazeneca-hands-over-some-rights-to-nexium-vimovo-to-grunenthal-as-its-plots-turnaround/

ENDPTS
31 Oct 2018

http://www.pharmabiz.com/NewsDetails.aspx?aid=112025&sid=2

PHARMABIZ
30 Oct 2018

https://www.genengnews.com/news/grunenthal-acquires-partial-rights-to-nexium-vimovo-from-astrazeneca-for-up-to-922m/

GENENGNEWS
30 Oct 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202461

FDA
05 Sep 2018
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