Decitabine
These highlights do not include all the information needed to use DECITABINE FOR INJECTION safely and effectively. See full prescribing information for DECITABINE FOR INJECTION Initial U.S. Approval:2006
Approved
Approval ID
77a7ea8f-3037-4ca6-b605-e5d1df5e7422
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Decitabine
PRODUCT DETAILS
NDC Product Code69097-905
Application NumberANDA205539
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 17, 2023
Generic NameDecitabine
INGREDIENTS (3)
DECITABINEActive
Quantity: 50 mg in 10 mL
Code: 776B62CQ27
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Code: 4J9FJ0HL51
Classification: IACT