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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205004

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NDA 205004 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Pharmascience Inc, Pharmobedient, Qilu Pharm Hainan, Reliance Life Sci, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Vilin Bio Med, Zydus Pharms, Maia Pharms Inc, and Shilpa, and is included in twenty-six NDAs. It is available from twenty-four suppliers. There are four patents protecting this drug. Additional details are available on the BORTEZOMIB profile page.

The generic ingredient in BORTEZOMIB is bortezomib. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bortezomib profile page.

Summary for 205004

Tradename:	BORTEZOMIB
Applicant:	Fresenius Kabi Usa
Ingredient:	bortezomib
Patents:	1

Medical Subject Heading (MeSH) Categories for 205004

Antineoplastic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	3.5MG/VIAL
Approval Date:	Nov 6, 2017	TE:		RLD:	No
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 3, 2032	Product Flag?	Y	Substance Flag?		Delist Request?

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