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Last Updated: December 12, 2025

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, Norvium Bioscience, Reliance Life, and Shilpa Medicare, and is included in sixteen NDAs. It is available from twenty-one 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-two 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

Pharmacology for NDA: 209540

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 209540

Antimetabolites, Antineoplastic
Enzyme Inhibitors

Suppliers and Packaging for NDA: 209540

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	209540	ANDA	Cipla USA Inc.	69097-368	69097-368-40	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (69097-368-40)

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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