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
5c0a2d5f-8c34-4c04-8425-7543965cedd4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Armas Pharmaceuticals Inc.
DUNS: 098405973
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 Code72485-201
Application NumberANDA207518
Product Classification
M
Marketing Category
C73584
G
Generic Name
azacitidine
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateDecember 22, 2020
FDA Product Classification
INGREDIENTS (2)
AZACITIDINEActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT