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  • TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;TOPICAL - 2%
  • TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
  • TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
  • SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TOPICAL - 1%
  • SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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=206771

FDA
12 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216548

FDA
11 May 2023

https://recalls-rappels.canada.ca/en/alert-recall/diclofenac-sodium-micronized-out-specification-affected-lot

HEALTH CANADA
21 Mar 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-launches-generic-joint-pain-drug-in-us-market/articleshow/96106366.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

ECONOMIC TIMES
09 Dec 2022

https://www.moneycontrol.com/news/business/companies/alembic-pharma-gets-usfda-nod-for-generic-drug-2-9633031.html

MONEYCONTROL
02 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212506

FDA
29 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216275

FDA
23 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208021

FDA
21 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208198

FDA
18 Aug 2022

https://www.expresspharma.in/aleor-dermaceuticals-gets-usfda-approval-for-diclofenac-sodium-topical-gel/

EXPRESS PHARMA
29 Jul 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212351

FDA
27 Jul 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207714

FDA
06 May 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-27-2022-1651037135.pdf

FDA
27 Apr 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-22-2021-1640158210.pdf

FDA
22 Dec 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-1-2021-1638337020.pdf

FDA
01 Dec 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206655

FDA
30 Jan 2021

https://www.perrigo.com/press-release/perrigo-announces-store-brand-equivalent-voltarenr-arthritis-pain-available-us-major

PRESS RELEASE
08 Sep 2020

https://www.perrigo.com/press-release/perrigo-announces-store-brand-equivalent-voltarenr-arthritis-pain-available-us-major

PRESS RELEASE
08 Sep 2020

https://www.pharmaexcipients.com/news/multiparticulate-formulations-diclofenac-sodium/

PHARMAEXCIPIENTS
23 Aug 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207714

FDA
05 Aug 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208098

FDA
31 Jul 2020

https://www.prnewswire.com/news-releases/perrigo-announces-fda-approval-for-the-store-brand-equivalent-of-voltaren-arthritis-pain-301035806.html

PR NEWSWIRE
06 Apr 2020

https://www.raps.org/news-and-articles/news-articles/2020/2/rx-to-otc-switches-fda-signs-off-on-three-drugs

Zachary Brennan RAPS
17 Feb 2020

https://www.fda.gov/news-events/press-announcements/fda-approves-three-drugs-nonprescription-use-through-rx-otc-switch-process

FDA
15 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208786

FDA
18 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211253

FDA
21 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204306

FDA
08 May 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-3-2019-1554267295.pdf

FDA
03 Apr 2019

https://www.raps.org/news-and-articles/news-articles/2019/1/asia-regulatory-roundup-tga-brings-6-guidance-doc?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2022%20January

Nick Paul Taylor RAPS
22 Jan 2019

https://www.prnewswire.com/news-releases/perrigo-launches-its-ab-rated-generic-version-of-solaraze-gel-3-300755902.html

PR NEWSWIRE
27 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209484

FDA
20 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209903

FDA
08 Aug 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210893

FDA
28 Jul 2018

https://www.prnewswire.com/news-releases/lannett-announces-multiple-product-launches-300684483.html

PR NEWSWIRE
23 Jul 2018

http://www.pharmabiz.com/ArticleDetails.aspx?aid=109977&sid=1

13 Jul 2018

https://www.thepharmaletter.com/in-brief/brief-ftc-imposes-conditions-on-amneal-acquisition-of-impax

PHARMA LETTER
11 Jul 2018

https://www.ftc.gov/news-events/press-releases/2018/07/ftc-approves-final-order-imposing-conditions-merger-generic-drug

FTC GOV
11 Jul 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-30-2018-1527659653.pdf

FDA
29 May 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206411

FDA
20 Apr 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208786

FDA
27 Oct 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206715

FDA
09 Aug 2017

http://www.raps.org/Regulatory-Focus/News/2017/07/13/28078/FDA-Publishes-21-New-13-Revised-Draft-Generic-Drug-Guidances/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

RAPS
13 Jul 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207238

15 May 2017

http://www.myepique.com/pdf/horizonactavis.pdf

PATENT LITIGATION
11 May 2017

https://www.pharmacompass.com/pdf/news/actavis-labs-ut-inc-gegeric-diclofenac-sodium-approved-in-us-1475663835.pdf

FDA
03 Oct 2016

https://www.pharmacompass.com/pdf/news/amneal-pharms-generic-diclofenac-sodium-approved-in-us-1473506705.pdf

FDA
02 Sep 2016

https://www.pharmacompass.com/pdf/news/par-forms-generic-diclofenac-potassium-approved-in-us-to-reduce-pain-and-inflammation-1462507646.pdf

FDA
02 May 2016

https://www.pharmacompass.com/pdf/news/taros-generic-diclofenac-sodium-approved-in-us-for-osteoarthritis-pain-1462507806.pdf

FDA
28 Apr 2016

http://www.prnewswire.com/news-releases/endo-provides-statement-regarding-expected-fda-approval-of-generic-voltaren-gel-product-300238782.html

PR NEWSWIRE
21 Mar 2016
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