🇺🇸 Tracrium Preservative Free in United States

FDA authorised Tracrium Preservative Free on 23 November 1983

Marketing authorisations

FDA — authorised 23 November 1983

  • Application: NDA018831
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: TRACRIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 December 1996

  • Application: ANDA074633
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 January 1997

  • Application: ANDA074768
  • Marketing authorisation holder: BAXTER HLTHCARE CORP
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 25 March 1997

  • Application: ANDA074639
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 March 1997

  • Application: ANDA074741
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 18 July 1997

  • Application: ANDA074900
  • Marketing authorisation holder: HIKMA
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 September 1997

  • Application: ANDA074825
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 July 1998

  • Application: ANDA074944
  • Marketing authorisation holder: WATSON LABS INC
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 17 February 2012

  • Application: ANDA091488
  • Marketing authorisation holder: MEITHEAL
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 18 October 2012

  • Application: ANDA090782
  • Marketing authorisation holder: HOSPIRA INC
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 8 April 2015

  • Application: ANDA206010
  • Marketing authorisation holder: EUGIA PHARMA
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 7 April 2017

  • Application: ANDA206001
  • Marketing authorisation holder: PHARMOBEDIENT
  • Local brand name: ATRACURIUM BESYLATE PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

Pricing & reimbursement

Tracrium Preservative Free in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Tracrium Preservative Free approved in United States?

Yes. FDA authorised it on 23 November 1983; FDA authorised it on 23 December 1996; FDA authorised it on 23 January 1997.

Who is the marketing authorisation holder for Tracrium Preservative Free in United States?

HOSPIRA holds the US marketing authorisation.

What does Tracrium Preservative Free cost in United States?

annual_list: USD 0.00 per year. Final patient cost depends on reimbursement and any patient access scheme.