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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 209540

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NDA 209540 describes AZACITIDINE, which is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Msn Labs Pvt Ltd, Natco Pharma Ltd, Pharmobedient, Reliance Life, and Shilpa Medicare, and is included in sixteen NDAs. It is available from twenty suppliers. Additional details are available on the AZACITIDINE profile page.

The generic ingredient in AZACITIDINE is azacitidine. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azacitidine profile page.

Summary for 209540

Tradename:	AZACITIDINE
Applicant:	Cipla
Ingredient:	azacitidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 209540

Antimetabolites, Antineoplastic
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS, SUBCUTANEOUS			Strength	100MG/VIAL
Approval Date:	May 4, 2018	TE:	AP	RLD:	No

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