Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212265


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NDA 212265 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, Lupin, Meitheal, MSN, Nivagen Pharms Inc, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty-one NDAs. It is available from eighteen suppliers. Additional details are available on the DECITABINE profile page.

The generic ingredient in DECITABINE is decitabine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 212265
Tradename:DECITABINE
Applicant:Msn
Ingredient:decitabine
Patents:0
Pharmacology for NDA: 212265
Mechanism of ActionNucleic Acid Synthesis Inhibitors
Suppliers and Packaging for NDA: 212265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine INJECTABLE;INTRAVENOUS 212265 ANDA BluePoint Laboratories 68001-713 68001-713-37 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-713-37) / 10 mL in 1 VIAL, SINGLE-DOSE
DECITABINE decitabine INJECTABLE;INTRAVENOUS 212265 ANDA Bryant Ranch Prepack 72162-2634 72162-2634-2 1 VIAL, SINGLE-USE in 1 CARTON (72162-2634-2) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:Aug 28, 2019TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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