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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205539

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NDA 205539 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 205539

Tradename:	DECITABINE
Applicant:	Gland
Ingredient:	decitabine
Patents:	0

Pharmacology for NDA: 205539

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 205539

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	205539	ANDA	Gland Pharma Limited	68083-528	68083-528-01	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Nov 23, 2020	TE:	AP	RLD:	No

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