Idarubicin hydrochloride
Idarubicin hydrochloride: 2 brands, 7 generics; first approved Sep 27, 1990; generic available.
Generic available: 7 ANDA applications approved.
Brand (NDA) products
- PFIZERNDA 05073419973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - PFIZERNDA 05066119903 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/VIAL POWDER INTRAVENOUS Discontinued - 5MG/VIAL POWDER INTRAVENOUS Discontinued - 20MG/VIAL POWDER INTRAVENOUS Discontinued -
Generic (ANDA) products (7)
- IDARUBICIN HYDROCHLORIDERISINGANDA 20014420123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - - IDARUBICIN HYDROCHLORIDESANDOZANDA 09129320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - - IDARUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 06544020093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued - - IDARUBICIN HYDROCHLORIDEHIKMAANDA 06528820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - IDARUBICIN HYDROCHLORIDEHIKMAANDA 06527520063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP - IDARUBICIN HYDROCHLORIDETEVA PARENTERALANDA 06503720023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL POWDER INTRAVENOUS Discontinued - 10MG/VIAL POWDER INTRAVENOUS Discontinued - 5MG/VIAL POWDER INTRAVENOUS Discontinued - - IDARUBICIN HYDROCHLORIDEMEITHEALANDA 06503620023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 10MG/10ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP 20MG/20ML (1MG/ML) SOLUTION INTRAVENOUS Rx AP
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1990–2012 across 9 FDA applications.
Idarubicin hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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