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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 215011


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NDA 215011 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 215011
Tradename:BORTEZOMIB
Applicant:Jiangsu Hansoh Pharm
Ingredient:bortezomib
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 215011
Mechanism of ActionProteasome Inhibitors
Medical Subject Heading (MeSH) Categories for 215011
Suppliers and Packaging for NDA: 215011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BORTEZOMIB bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 215011 ANDA Hikma Pharmaceuticals USA Inc. 0143-9098 0143-9098-01 1 VIAL in 1 CARTON (0143-9098-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

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

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