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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

87f7a39d-06db-48ca-be21-9e8806608439

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 23, 2022

Manufacturers
FDA

Sandoz Inc

DUNS: 005387188

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 Code0781-9253
Application NumberNDA050794
Product Classification
M
Marketing Category
C73605
G
Generic Name
azacitidine
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateSeptember 23, 2022
FDA Product Classification

INGREDIENTS (2)

AZACITIDINEActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

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Azacitidine - FDA Drug Approval Details