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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 215765

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NDA 215765 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 215765

Tradename:	AZACITIDINE
Applicant:	Hetero Labs Ltd Vi
Ingredient:	azacitidine
Patents:	0

Pharmacology for NDA: 215765

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for 215765

Antimetabolites, Antineoplastic
Enzyme Inhibitors

Suppliers and Packaging for NDA: 215765

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZACITIDINE	azacitidine	POWDER;INTRAVENOUS, SUBCUTANEOUS	215765	ANDA	Camber Pharmaceuticals, Inc.	31722-365	31722-365-31	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (31722-365-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS, SUBCUTANEOUS			Strength	100MG/VIAL
Approval Date:	Oct 15, 2024	TE:	AP	RLD:	No

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