Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212117

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NDA 212117 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, Lupin, Meitheal, MSN, Nivagen Pharms Inc, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty-one NDAs. It is available from eighteen suppliers. Additional details are available on the DECITABINE profile page.

The generic ingredient in DECITABINE is decitabine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.

Summary for 212117

Tradename:	DECITABINE
Applicant:	Nivagen Pharms Inc
Ingredient:	decitabine
Patents:	0

Pharmacology for NDA: 212117

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 212117

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DECITABINE	decitabine	INJECTABLE;INTRAVENOUS	212117	ANDA	Nivagen Pharmaceuticals, Inc.	75834-190	75834-190-01	1 VIAL in 1 CARTON (75834-190-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Dec 7, 2020	TE:	AP	RLD:	No

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