🇺🇸 Idamycin Pfs in United States

FDA authorised Idamycin Pfs on 17 February 1997

Marketing authorisations

FDA — authorised 17 February 1997

  • Application: NDA050734
  • Marketing authorisation holder: PFIZER
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

The FDA approved Idamycin Pfs, a product of Pfizer, for its approved labeling on February 6, 2026. This approval was granted through the standard expedited pathway. Idamycin Pfs is a pharmaceutical product, but the specific local brand name is not reported.

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FDA — authorised 1 May 2002

  • Application: ANDA065037
  • Marketing authorisation holder: TEVA PARENTERAL
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: POWDER — INTRAVENOUS
  • Status: approved

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FDA — authorised 1 May 2002

  • Application: ANDA065036
  • Marketing authorisation holder: MEITHEAL
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 14 December 2006

  • Application: ANDA065275
  • Marketing authorisation holder: HIKMA
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 15 May 2007

  • Application: ANDA065288
  • Marketing authorisation holder: HIKMA
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 4 August 2009

  • Application: ANDA065440
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 29 March 2011

  • Application: ANDA091293
  • Marketing authorisation holder: SANDOZ
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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FDA — authorised 11 October 2012

  • Application: ANDA200144
  • Marketing authorisation holder: RISING
  • Local brand name: IDARUBICIN HYDROCHLORIDE
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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Idamycin Pfs in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Idamycin Pfs approved in United States?

Yes. FDA authorised it on 17 February 1997; FDA authorised it on 1 May 2002; FDA authorised it on 1 May 2002.

Who is the marketing authorisation holder for Idamycin Pfs in United States?

PFIZER holds the US marketing authorisation.