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  • TABLET;ORAL - 375MG
  • TABLET;ORAL - 500MG
  • SUSPENSION;ORAL - 25MG/ML
  • TABLET, DELAYED RELEASE;ORAL - 375MG
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  • TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.pharmacompass.com/pdf/news/enforcement-report-week-of-december-6-2023-46648.pdf

FDA
06 Dec 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204470

FDA
24 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215776

FDA
07 Jun 2022

https://www.newswire.ca/news-releases/labelling-update-regarding-the-use-of-non-steroidal-anti-inflammatory-drugs-nsaids-beyond-20-weeks-of-pregnancy-and-risk-of-kidney-damage-to-unborn-babies-866562162.html

NEWSWISE
08 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211910

FDA
16 Mar 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212705

FDA
31 Jul 2020

https://www.moneycontrol.com/news/business/lupin-launches-generic-arthritis-relief-tablet-in-us-5005841.html

BUSINESSWIRE
05 Mar 2020

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

BUSINESSWIRE
27 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212517

FDA
25 Feb 2020

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

FDA
23 Feb 2019

https://www.usatoday.com/story/opinion/2019/01/12/why-fda-doesnt-always-catch-tainted-medicines/2538786002/

Sydney Lupkin USA TODAY
11 Jan 2019

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

FDA
28 Dec 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://globenewswire.com/news-release/2018/09/27/1576930/0/en/Nicox-and-Fera-Pharmaceuticals-to-Focus-on-a-Rare-Disease-Indication-for-Naproxcinod.html

GLOBENEWSWIRE
26 Sep 2018

https://www.reuters.com/article/us-health-heart-diclofenac/common-painkiller-tied-to-increased-risk-of-heart-problems-idUSKCN1M12CD?feedType=RSS&feedName=healthNews

Ankur Banerjee REUTERS
22 Sep 2018

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

FDA
05 Sep 2018

https://www.fiercebiotech.com/antibe-builds-case-for-gi-safety-naproxen-alternative

Nick P. Taylor FIERCE BIOTECH
04 Jul 2018

https://www.biospace.com/article/releases/antibe-therapeutics-announces-successful-phase-2b-gastrointestinal-safety-study-for-lead-pain-drug-atb-346/

Mark Terry BIOSPACE
20 Mar 2018

https://www.reuters.com/article/us-health-nsaids-overdosing/many-people-take-dangerously-high-amounts-of-ibuprofen-idUSKBN1FS336

Lisa Rapaport REUTERS
09 Feb 2018

https://www.fiercepharma.com/pharma/specialty-pharmacy-scrutiny-hits-again-state-s-focus-horizon-meds

Tracy Staton FIERCE PHARMA
09 Dec 2017

http://www.wsj.com/articles/study-suggests-celebrex-isnt-riskier-than-rival-pain-drugs-1479073501

RON WINSLOW WALL STREET JOURNAL
15 Nov 2016

http://www.reuters.com/article/us-health-nsaids-heart-failure-idUSKCN12K2J1

REUTERS
21 Oct 2016

http://www.pharma-excipients.ch/2016/03/03/novel-naproxen-esomeprazole-magnesium-compound-pellets-based-on-acid-independent-mechanism-in-vitro-and-in-vivo-evaluation/

PHARMA-EXCIPIENTS
02 Mar 2016

http://www.fiercepharmamarketing.com/press-releases/ready-enter-partnering-discussions-key-oxpzero-nsaids

FIERCE PHARMA MARKETING
25 Jan 2016

http://www.fiercepharma.com/story/big-pharmas-steady-double-digit-price-hikes-cost-medicare-billions/2015-12-22

Tracy Staton FIERCE PHARMA
22 Dec 2015

http://www.forbes.com/sites/johnlamattina/2015/09/02/uk-study-indicates-that-the-cardiovascular-risk-of-celebrex-no-different-from-other-pain-drugs/

John LaMattina FORBES
03 Sep 2015

http://www.prevention.com/health/painkiller-safety?

CAREY ROSSI PREVENTION
22 Jul 2015

http://www.fiercepharma.com/story/heres-ma-strategy-buy-products-hike-prices-watch-sales-grow/2015-04-27

 Carly Helfand FIERCE PHARMA
27 Apr 2015

http://www.fiercepharma.com/story/pernix-figures-1-1-1-equals-more-three-new-zohydro-salesforce/2015-03-18

Tracy Staton FIERCE PHARMA
18 Mar 2015

http://www.prnewswire.com/news-releases/nanosphere-health-sciences-announces-patent-pending-status-for-nanoparticle-encapsulation-of-nsaids-300019412.html

PR NEWSWIRE
13 Jan 2015

http://ir.horizon-pharma.com/news-releases/news-release-details/horizon-pharma-plc-files-patent-infringement-lawsuit-against

PRESS RELEASE HORIZON PHARMA
24 Dec 2014
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