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, for intravenous use Initial U.S. Approval: 2006
Approved
Approval ID
4e1f4eb4-19b2-eee8-3402-bd2ccf622791
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2021
Manufacturers
FDA
Dr.Reddy's Laboratories Limited
DUNS: 650562841
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 Code55111-556
Application NumberANDA203131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Decitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 16, 2021
FDA Product Classification
INGREDIENTS (3)
potassium phosphate, monobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
DecitabineActive
Quantity: 50 mg in 10 mL
Code: 776B62CQ27
Classification: ACTIB