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
a3c1551a-41aa-4508-9d88-0210b2d4df78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2020
Manufacturers
FDA
MSN LABORATORIES PRIVATE LIMITED
DUNS: 650786952
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 Code69539-115
Application NumberANDA212265
Product Classification
M
Marketing Category
C73584
G
Generic Name
Decitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 27, 2020
FDA Product Classification
INGREDIENTS (4)
DECITABINEActive
Quantity: 50 mg in 10 mL
Code: 776B62CQ27
Classification: ACTIB
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT