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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 204405


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NDA 204405 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Mylan Labs Ltd, Pharmascience Inc, Qilu Pharm Hainan, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Waverley Pharma Inc, Zydus Pharms, and Maia Pharms Inc, and is included in twenty-three NDAs. It is available from nineteen suppliers. There are three 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 suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
Summary for 204405
Tradename:BORTEZOMIB
Applicant:Accord Hlthcare
Ingredient:bortezomib
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204405

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:Jul 26, 2022TE:RLD:No

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