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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 205160

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NDA 205160 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, Norvium Bioscience, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Zydus Pharms, Maia Pharms Inc, and Shilpa, and is included in twenty-five 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 205160

Tradename:	BORTEZOMIB
Applicant:	Norvium Bioscience
Ingredient:	bortezomib
Patents:	0

Medical Subject Heading (MeSH) Categories for 205160

Antineoplastic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	3.5MG/VIAL
Approval Date:	Oct 31, 2022	TE:		RLD:	No

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