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  • INJECTABLE;INJECTION - 100MG/ML
  • TABLET;ORAL - 650MG

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218599

FDA
16 Apr 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216877

FDA
16 Apr 2024

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-12-2022-83607.pdf

FDA
12 Oct 2022

https://www.globenewswire.com/news-release/2022/07/20/2482362/0/en/Hyloris-Reports-Positive-Phase-1-Data-for-HY-004-a-proprietary-Tranexamic-Acid-Oral-Mouth-Rinse-for-bleeding-related-to-dental-procedures.html

GLOBENEWSWIRE
20 Jul 2022

https://www.businesswire.com/news/home/20210929005565/en

BUSINESSWIRE
29 Sep 2021

https://amilifesciences.com/left_service/ami-lifesciences-first-generic-company-to-receive-dcgi-approval-for-obeticholic-acid/

PRESS RELEASE
18 Aug 2021

https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003601

PIOS
23 Jul 2021

https://www.empr.com/home/news/safety-alerts-and-recalls/fda-risk-of-inadvertent-intrathecal-administration-of-tranexamic-acid-injection/#:~:text=by%20intravenous%20route.-,The%20FDA%20notes%20that%20the%20inadvertent%20intrathecal%20administration%20of%20tranexamic,permanent%20neurological%20injury%2C%20and%20death.

Brian Park BUSINESSWIRE
04 Dec 2020

https://jamanetwork.com/journals/jamasurgery/fullarticle/2771225

JAMA NETWORK
06 Oct 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-9-2020-1600260117.pdf

FDA
09 Sep 2020

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-four-lots-amiodarone-hcl-injection-usp-and-tranexamic#:~:text=Mylan%20N.V.%20(NASDAQ%3A%20MYL),Injection%2C%20USP%201000%20mg%2F10

FDA
01 Sep 2020

https://www.prnewswire.com/news-releases/mylan-initiates-voluntary-nationwide-recall-of-four-lots-of-amiodarone-hcl-injection-usp-and-tranexamic-acid-injection-usp-due-to-carton-label-mix-up-301120584.html

PRNEWSWIRE
28 Aug 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209860

FDA
15 Jan 2020

https://www.business-standard.com/article/companies/strides-bengaluru-unit-gets-voluntary-indicated-action-status-from-usfda-119072000190_1.html

BUSINESS STANDARD
22 Jul 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212360

FDA
20 Jul 2019

http://pharmabiz.com/ArticleDetails.aspx?aid=115187&sid=1

PHARMABIZ
12 Apr 2019

https://www.pharmacompass.com/pdf/news/erfa-canada-2012-recalls-erfa-tranexamic-100-mgml-5-ml-1525761805.pdf

HEALTH CANADA
08 May 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206594

FDA
29 Sep 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205228

FDA
19 Jul 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206713

FDA
29 Jun 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208840

FDA
28 Feb 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207239

FDA
13 Feb 2017

https://www.pharmacompass.com/pdf/news/amerigen-pharms-antifibrinolytic-generic-drug-tranexamic-acid-approved-in-usa-1469863341.pdf

FDA
26 Jul 2016

https://www.pharmacompass.com/pdf/news/north-creeks-generic-tranexamic-acid-approved-in-us-to-reduce-heavy-bleeding-1456829577.pdf

FDA
25 Feb 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharma-gets-usfda-nod-for-two-generic-drugs/articleshow/50604765.cms

ECONOMIC TIMES
18 Jan 2016

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

23 Sep 2015
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