Mitoxantrone
MitoXANTRONE Injection, USP (concentrate)
Approved
Approval ID
accf9569-4b57-4e83-a7db-4e890a75d1ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mitoxantrone
PRODUCT DETAILS
NDC Product Code61703-343
Application NumberANDA076871
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
Generic NameMitoxantrone
INGREDIENTS (6)
MITOXANTRONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: U6USW86RD0
Classification: ACTIM
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT