Last Updated: November 13, 2026

Details for New Drug Application (NDA): 217814

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NDA 217814 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, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Somerset Theraps Llc, 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 217814

Tradename:	DECITABINE
Applicant:	Somerset Theraps Llc
Ingredient:	decitabine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	50MG/VIAL
Approval Date:	Dec 19, 2025	TE:	AP	RLD:	No

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