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  • INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML)
  • INJECTABLE;INJECTION - 50MG/50ML (1MG/ML)
  • INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML)
  • INJECTABLE;INTRAVENOUS - 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INTRAVENOUS - 125MG/125ML (1MG/ML)

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217848

FDA
31 Jul 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-19-2018-1537361296.pdf

FDA
19 Sep 2018

https://www.pharmacompass.com/pdf/news/gattex-teduglutide-amlodipine-and-valsartan-tabs-shire-nps-pharm-v-par-pharma-et-al-1533038693.pdf

PATENT LITIGATION
30 Jul 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206698

FDA
31 Jan 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-26-2017-1501044953.pdf

FDA
26 Jul 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205570

FDA
24 May 2017

https://www.pharmacompass.com/pdf/news/hospira-inc-generic-argatroban-approved-in-us-1475059450.pdf

FDA
17 Sep 2016

http://www.pharmamanufacturing.com/industrynews/2016/teva-recalls-4-drugs-made-at-banned-plant/

PHARMAMANUFACTURING
15 Sep 2016

https://www.pharmacompass.com/pdf/news/teva-pharms-usa-inc-gets-nda-206769-approval-for-argatroban-1443704784.pdf

15 Dec 2014
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