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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205582

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NDA 205582 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 205582

Tradename:	DECITABINE
Applicant:	Sun Pharm
Ingredient:	decitabine
Patents:	0

Suppliers and Packaging for NDA: 205582

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DECITABINE	decitabine	POWDER;INTRAVENOUS	205582	NDA	Sun Pharmaceutical Industries, Inc.	47335-361	47335-361-41	1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Jan 28, 2014	TE:		RLD:	Yes

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