AZACITIDINE
These highlights do not include all the information needed to use AZACITIDINE FOR INJECTION safely and effectively. See full prescribing information for AZACITIDINE FOR INJECTION. AZACITIDINE for injection for subcutaneous or intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
b4bcca95-d0b0-42dd-9dbb-637ab98effcc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2020
Manufacturers
FDA
CELLTRION USA, INC.
DUNS: 116587378
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azacitidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-558
Application NumberANDA207518
Product Classification
M
Marketing Category
C73584
G
Generic Name
azacitidine
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 7, 2020
FDA Product Classification
INGREDIENTS (2)
AZACITIDINEActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT