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Last Updated: December 15, 2025

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, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty NDAs. It is available from nineteen suppliers. Additional details are available on the DECITABINE profile page.

The generic ingredient in DECITABINE is decitabine. There are eighteen drug master file entries for this compound. Nineteen 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 Novadoz Pharmaceuticals LLC 72205-031 72205-031-01 1 VIAL, SINGLE-USE in 1 CARTON (72205-031-01) / 20 mL in 1 VIAL, SINGLE-USE
DECITABINE decitabine INJECTABLE;INTRAVENOUS 212265 ANDA Novadoz Pharmaceuticals LLC 72205-036 72205-036-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-036-01) / 10 mL in 1 VIAL, SINGLE-DOSE

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, 2025, www.DrugPatentWatch.com.
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