🇺🇸 DOPAMINE HYDROCHLORIDE in United States

FDA authorised DOPAMINE HYDROCHLORIDE on 25 February 1974

Marketing authorisations

FDA — authorised 25 February 1974

  • Application: NDA017395
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: INTROPIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 19 May 1981

  • Application: NDA018132
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 June 1983

  • Application: NDA018656
  • Marketing authorisation holder: TELIGENT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 September 1983

  • Application: NDA018826
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

FDA — authorised 23 October 1985

  • Application: ANDA070092
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 October 1985

  • Application: ANDA070091
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 15 October 1986

  • Application: NDA019099
  • Marketing authorisation holder: B BRAUN
  • Local brand name: DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 February 1987

  • Application: ANDA070826
  • Marketing authorisation holder: AM REGENT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 February 1987

  • Application: ANDA070799
  • Marketing authorisation holder: AM REGENT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 February 1987

  • Application: ANDA070820
  • Marketing authorisation holder: AM REGENT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 27 March 1987

  • Application: NDA019615
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Local brand name: DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 October 1991

  • Application: ANDA072999
  • Marketing authorisation holder: TEVA PARENTERAL
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 October 1991

  • Application: ANDA073000
  • Marketing authorisation holder: TEVA PARENTERAL
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 August 1995

  • Application: NDA020542
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 23 May 1996

  • Application: ANDA074403
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 11 April 2018

  • Application: ANDA207707
  • Marketing authorisation holder: HIKMA INTL PHARMS
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070657
  • Marketing authorisation holder: ABBOTT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070656
  • Marketing authorisation holder: ABBOTT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070093
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070094
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070013
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: NDA018138
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070012
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070558
  • Marketing authorisation holder: WARNER CHILCOTT
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

FDA

  • Application: ANDA070011
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070364
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070058
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070059
  • Marketing authorisation holder: ABRAXIS PHARM
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070047
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070046
  • Marketing authorisation holder: SMITH AND NEPHEW
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070087
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070089
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Application: ANDA070090
  • Marketing authorisation holder: IGI LABS INC
  • Local brand name: DOPAMINE HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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DOPAMINE HYDROCHLORIDE 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 DOPAMINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 25 February 1974; FDA authorised it on 19 May 1981; FDA authorised it on 28 June 1983.

Who is the marketing authorisation holder for DOPAMINE HYDROCHLORIDE in United States?

HOSPIRA holds the US marketing authorisation.