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FDA Drug information

Decitabine

Read time: 1 mins
Marketing start date: 29 Apr 2024

Summary of product characteristics


Effective Time

20221017

Version

2

Spl Product Data Elements

Decitabine Decitabine DECITABINE DECITABINE POTASSIUM PHOSPHATE, MONOBASIC SODIUM HYDROXIDE HYDROCHLORIC ACID

Application Number

ANDA214486

Brand Name

Decitabine

Generic Name

Decitabine

Product Ndc

70771-1713

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1713-1 Decitabine for Injection 50 mg per vial FOR INTRAVENOUS INFUSION ONLY WARNING: Cytotoxic Agent Single-Dose Sterile Vial – Discard unused portion. Rx only NDC 70771-1713-1 Decitabine for Injection 50 mg per vial FOR INTRAVENOUS INFUSION ONLY WARNING: Cytotoxic Agent Single-Dose Sterile Vial – Discard unused portion. Rx only container label carton label

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