🇺🇸 IOPAMIDOL in United States

FDA authorised IOPAMIDOL on 31 December 1985

Marketing authorisations

FDA — authorised 31 December 1985

  • Application: NDA018735
  • Marketing authorisation holder: BRACCO
  • Local brand name: ISOVUE-M 300
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved IOPAMIDOL, a pharmaceutical product, for its approved indication on 10 October 2025. The marketing authorisation was granted to BRACCO, the marketing authorisation holder. IOPAMIDOL was approved through the standard expedited pathway.

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FDA — authorised 6 November 1996

  • Application: ANDA074629
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Local brand name: IOPAMIDOL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 2 April 1997

  • Application: ANDA074679
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: IOPAMIDOL-250
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 3 April 1997

  • Application: ANDA074637
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: IOPAMIDOL-300 IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 April 1997

  • Application: ANDA074638
  • Marketing authorisation holder: ABBVIE
  • Local brand name: IOPAMIDOL-300
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 December 1997

  • Application: ANDA074898
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: IOPAMIDOL-250
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 30 December 1997

  • Application: ANDA074636
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: IOPAMIDOL-250 IN PLASTIC CONTAINER
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 24 February 1998

  • Application: ANDA075005
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: IOPAMIDOL-250
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 28 July 2000

  • Application: ANDA074881
  • Marketing authorisation holder: COOK IMAGING
  • Local brand name: IOPAMIDOL-200
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 22 January 2016

  • Application: NDA020327
  • Marketing authorisation holder: BRACCO
  • Indication: Labeling
  • Status: approved

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FDA — authorised 27 February 2023

  • Application: ANDA215382
  • Marketing authorisation holder: HAINAN POLY
  • Local brand name: IOPAMIDOL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 27 September 2023

  • Application: ANDA217134
  • Marketing authorisation holder: HAINAN POLY
  • Local brand name: IOPAMIDOL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved IOPAMIDOL for manufacturing (CMC) purposes on 2024-04-09. This approval was granted to HAINAN POLY under application number ANDA217134. The approval was processed through the standard expedited pathway.

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FDA

  • Application: ANDA074734
  • Marketing authorisation holder: HOSPIRA
  • Local brand name: IOPAMIDOL
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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IOPAMIDOL 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 IOPAMIDOL approved in United States?

Yes. FDA authorised it on 31 December 1985; FDA authorised it on 6 November 1996; FDA authorised it on 2 April 1997.

Who is the marketing authorisation holder for IOPAMIDOL in United States?

BRACCO holds the US marketing authorisation.