APPLICATION
ANDA065036
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-01
LATEST ACTION
2023-03-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
IDARUBICIN HYDROCHLORIDEPrescription
IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) · SOLUTION · INTRAVENOUS
IDARUBICIN HYDROCHLORIDEPrescription
IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) · SOLUTION · INTRAVENOUS
IDARUBICIN HYDROCHLORIDEPrescription
IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2023-03-27Labeling · Supplement 34 · standardAP
2022-01-27Labeling · Supplement 33 · standardAP
2020-04-27Labeling · Supplement 27 · standardAP
2020-04-27Labeling · Supplement 30 · standardAP
2011-11-22Labeling · Supplement 19AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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