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. DECITABINE for injection, for intravenous use. Initial U.S. Approval: 2006
Approved
Approval ID
447a9fbd-106d-4ff6-8fd0-bb38a8c90e17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2020
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
decitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-316
Application NumberANDA204607
Product Classification
M
Marketing Category
C73584
G
Generic Name
decitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 26, 2020
FDA Product Classification
INGREDIENTS (3)
DECITABINEActive
Quantity: 50 mg in 20 mL
Code: 776B62CQ27
Classification: ACTIB
POTASSIUM PHOSPHATE, MONOBASICInactive
Quantity: 68 mg in 20 mL
Code: 4J9FJ0HL51
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 11.6 mg in 20 mL
Code: 55X04QC32I
Classification: IACT