🇺🇸 Heparin Sodium In Plastic Container in United States

FDA authorised Heparin Sodium In Plastic Container on 9 February 1939

Marketing authorisations

FDA — authorised 9 February 1939

  • Application: NDA000552
  • Marketing authorisation holder: ASPEN GLOBAL INC
  • Local brand name: LIQUAEMIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 5 February 1942

  • Application: NDA004570
  • Marketing authorisation holder: PHARMACIA AND UPJOHN
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 4 May 1943

  • Application: NDA005264
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 19 May 1944

  • Application: NDA005521
  • Marketing authorisation holder: LILLY
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 22 February 1972

  • Application: NDA017029
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 May 1974

  • Application: NDA017007
  • Marketing authorisation holder: HIKMA
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 22 November 1974

  • Application: NDA017064
  • Marketing authorisation holder: DR REDDYS
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 10 December 1975

  • Application: NDA017486
  • Marketing authorisation holder: EPIC PHARMA LLC
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 10 February 1978

  • Application: NDA017651
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 21 April 1978

  • Application: NDA017780
  • Marketing authorisation holder: PHARM SPEC
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 21 December 1978

  • Application: NDA017979
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 13 March 1979

  • Application: ANDA086357
  • Marketing authorisation holder: INTL MEDICATION
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 22 February 1980

  • Application: ANDA086129
  • Marketing authorisation holder: PHARMA SERVE NY
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 April 1982

  • Application: NDA018609
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Local brand name: HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 31 January 1984

  • Application: NDA018916
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 January 1985

  • Application: NDA018911
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 29 March 1985

  • Application: NDA019135
  • Marketing authorisation holder: B BRAUN
  • Local brand name: HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 3 June 1986

  • Application: ANDA089464
  • Marketing authorisation holder: DR REDDYS
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 20 July 1992

  • Application: NDA019953
  • Marketing authorisation holder: B BRAUN
  • Local brand name: HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 20 July 1992

  • Application: NDA019952
  • Marketing authorisation holder: B BRAUN
  • Local brand name: HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 1 December 1993

  • Application: ANDA088100
  • Marketing authorisation holder: HOSPIRA
  • Indication: Manufacturing (CMC)
  • Status: approved

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FDA — authorised 10 October 1995

  • Application: ANDA040008
  • Marketing authorisation holder: WATSON LABS INC
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 7 June 1996

  • Application: ANDA040007
  • Marketing authorisation holder: DR REDDYS
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 31 August 2009

  • Application: ANDA090571
  • Marketing authorisation holder: HOSPIRA INC
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 June 2010

  • Application: ANDA090810
  • Marketing authorisation holder: SAGENT PHARMS
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 8 June 2011

  • Application: ANDA201002
  • Marketing authorisation holder: PLANO PHARMS
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 12 June 2014

  • Application: ANDA203198
  • Marketing authorisation holder: SHENZHEN TECHDOW
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 12 June 2014

  • Application: ANDA202732
  • Marketing authorisation holder: SHENZHEN TECHDOW
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 12 June 2014

  • Application: ANDA202957
  • Marketing authorisation holder: SHENZHEN TECHDOW
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 10 June 2016

  • Application: ANDA206552
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Status: approved

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FDA — authorised 6 February 2017

  • Application: ANDA205323
  • Marketing authorisation holder: GLAND
  • Status: approved

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FDA — authorised 14 December 2018

  • Application: ANDA211005
  • Marketing authorisation holder: EMERGE BIOSCIENCE
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 May 2019

  • Application: ANDA211007
  • Marketing authorisation holder: EMERGE BIOSCIENCE
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 24 February 2020

  • Application: ANDA211004
  • Marketing authorisation holder: EMERGE BIOSCIENCE
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 2 April 2020

  • Application: ANDA212060
  • Marketing authorisation holder: EMERGE BIOSCIENCE
  • Local brand name: HEPARIN SODIUM PRESERVATIVE FREE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 15 July 2020

  • Application: ANDA212061
  • Marketing authorisation holder: EMERGE BIOSCIENCE
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 24 July 2020

  • Application: ANDA212441
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 29 July 2020

  • Application: ANDA203851
  • Marketing authorisation holder: PHARMOBEDIENT
  • Indication: Labeling
  • Status: approved

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FDA — authorised 29 December 2020

  • Application: ANDA214839
  • Marketing authorisation holder: BE PHARMS
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 29 December 2020

  • Application: ANDA214804
  • Marketing authorisation holder: BE PHARMS
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: NDA017027
  • Marketing authorisation holder: 3M
  • Local brand name: LIPO-HEPIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087043
  • Marketing authorisation holder: SOLOPAK
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: NDA017130
  • Marketing authorisation holder: CHAMBERLIN PARENTERL
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: NDA019130
  • Marketing authorisation holder: MCGAW
  • Local brand name: HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA088580
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087905
  • Marketing authorisation holder: SOLOPAK
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087906
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA088239
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: NDA017033
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087904
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087903
  • Marketing authorisation holder: SOLOPAK
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA088581
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087077
  • Marketing authorisation holder: SOLOPAK
  • Local brand name: HEPARIN SODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087959
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA087958
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: HEPARIN LOCK FLUSH
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Heparin Sodium In Plastic Container 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 Heparin Sodium In Plastic Container approved in United States?

Yes. FDA authorised it on 9 February 1939; FDA authorised it on 5 February 1942; FDA authorised it on 4 May 1943.

Who is the marketing authorisation holder for Heparin Sodium In Plastic Container in United States?

ASPEN GLOBAL INC holds the US marketing authorisation.