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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203131


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NDA 203131 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 203131
Tradename:DECITABINE
Applicant:Dr Reddys
Ingredient:decitabine
Patents:0
Pharmacology for NDA: 203131
Mechanism of ActionNucleic Acid Synthesis Inhibitors
Suppliers and Packaging for NDA: 203131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DECITABINE decitabine INJECTABLE;INTRAVENOUS 203131 ANDA Dr. Reddy's Laboratories Inc. 43598-348 43598-348-37 1 VIAL, SINGLE-USE in 1 CARTON (43598-348-37) / 10 mL in 1 VIAL, SINGLE-USE
DECITABINE decitabine INJECTABLE;INTRAVENOUS 203131 ANDA Dr. Reddy's Laboratories Inc. 43598-427 43598-427-37 1 VIAL, SINGLE-USE in 1 CARTON (43598-427-37) / 10 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/VIAL
Approval Date:Jul 11, 2013TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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