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Last Updated: March 28, 2026

Details for New Drug Application (NDA): 203654

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NDA 203654 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Caplin One Labs, 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, Scinopharm Taiwan, Shuangcheng, Teva Pharms Usa, Vilin Bio Med, Zydus Pharms, Gland, Maia Pharms Inc, and Shilpa, and is included in twenty-eight 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 203654

Tradename:	BORTEZOMIB
Applicant:	Caplin One Labs
Ingredient:	bortezomib
Patents:	0

Medical Subject Heading (MeSH) Categories for 203654

Antineoplastic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	3.5MG/VIAL
Approval Date:	Jul 26, 2022	TE:	AP	RLD:	No

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