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FDA Product

Decitabine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Decitabine

67184-0535

Regulatory Information

67184-0535

ANDA212826

C73584

April 12, 2021

USA

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

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

653878256

Active Ingredients

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

POTASSIUM PHOSPHATE, MONOBASIC

Code: 4J9FJ0HL51

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

DECITABINE

Quantity: 50 mg in 20 mL

Code: 776B62CQ27

Class Code: ACTIB

Active Moieties

DECITABINE

Code: 776B62CQ27

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