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  • TABLET, EXTENDED RELEASE;ORAL - EQ 129MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 161MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 193MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 258MG BASE

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-7-2023-80553.pdf

FDA
07 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214580

FDA
20 Dec 2022

https://www.expresspharma.in/us-fda-grants-tentative-approval-to-zyduss-amantadine-extended-release-capsules/

EXPRESS PHARMA
10 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214897

FDA
29 Sep 2022

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/strides-pharma-arm-gets-usfda-nod-to-market-amantadine-hydrochloride-softgel-capsules-in-america/articleshow/89720391.cms

ECONOMIC TIMES
20 Feb 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211354

FDA
18 Feb 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214178

FDA
20 Aug 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214178

FDA
20 Aug 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214284

FDA
20 Oct 2020

https://www.globenewswire.com/news-release/2020/07/15/2062508/0/en/Adamas-presents-new-post-hoc-Phase-3-data-analysis-for-GOCOVRI-in-Parkinson-s-disease-at-the-2020-American-Academy-of-Neurology-AAN-Science-Highlights-Platform.html

GLOBENEWLSWIRE
15 Jul 2020

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-gocovri-208944-amantadine-extended-release-capsules-685-mg-1592885636.pdf

FDA
22 Jun 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212044

FDA
26 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210129

FDA
04 Mar 2020

https://www.globenewswire.com/news-release/2020/01/02/1965715/0/en/Adamas-Announces-Settlement-of-Patent-Litigation-with-Sandoz-Inc.html

GLOBENEWSWIRE
03 Jan 2020

https://www.federalregister.gov/documents/2019/12/02/2019-25946/morton-grove-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-21-abbreviated-new-drug

FEDERALREGISTER
02 Dec 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-25-2018-1524633895.pdf

FDA
25 Apr 2018

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-gocovri-amantadine-extended-release-capsules-1521005151.pdf

FDA
13 Mar 2018

https://www.pharmacompass.com/pdf/news/gocovriosmolex-eramantadine-hcl-osmotica-pharmaceutical-us-v-adamas-pharm-1520247913.pdf

PATENT LITIGATION
16 Feb 2018

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/jubilant-pharma-gets-usfda-nod-for-symmetrels-generic-version/articleshow/62848076.cms

ECONOMIC TIMES
09 Feb 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-9-2017-1502256126.pdf

FDA
09 Aug 2017

https://www.pharmacompass.com/pdf/news/apace-packaging-llc-issues-voluntary-nationwide-recall-of-cyclobenzaprine-hcl-and-amantadine-hcl-lot-16710-1501216022.pdf

FDA
28 Jul 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208966

FDA
22 Jun 2017

http://www.moneycontrol.com/news/business/alembic-pharma-gets-usfda-nod-for-anti-influenza-drug-2309967.html

MONEY CONTROL
22 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209221

FDA
19 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209171

FDA
15 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209047

FDA
08 Jun 2017

https://www.drugtargetreview.com/article/21644/ketamine-depression/

DRUG TARGET REVIEW
30 Jan 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208107

FDA
06 Dec 2016

http://www.prnewswire.com/news-releases/lannett-announces-approval-for-amantadine-hydrochloride-capsules-usp-100-mg-300475076.html

PR NEWSWIRE
17 Jun 2016

https://www.pharmacompass.com/pdf/news/zydus-generic-amantadine-hydrochloride-approved-in-us-for-parkinsons-disease-1464869199.pdf

FDA
01 Jun 2016

http://www.fiercepharmamanufacturing.com/story/attix-pharmaceuticals-recalls-hundreds-apis-us/2015-04-30

Eric Palmer FIERCE PHARMA MFG
02 May 2015

http://www.actavis.com/news/news/thomson-reuters/actavis-will-appeal-injunction-requiring-continued

Press Release Actavis
15 Dec 2014
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