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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203475

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NDA 203475 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 203475

Tradename:	DECITABINE
Applicant:	Accord Hlthcare
Ingredient:	decitabine
Patents:	0

Pharmacology for NDA: 203475

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 203475

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	203475	ANDA	Accord Healthcare Inc.	16729-224	16729-224-05	1 VIAL in 1 CARTON (16729-224-05) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Feb 27, 2017	TE:	AP	RLD:	No

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