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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 213823


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NDA 213823 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 213823
Tradename:BORTEZOMIB
Applicant:Baxter Hlthcare Corp
Ingredient:bortezomib
Patents:0
Pharmacology for NDA: 213823
Mechanism of ActionProteasome Inhibitors
Medical Subject Heading (MeSH) Categories for 213823
Suppliers and Packaging for NDA: 213823
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BORTEZOMIB bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 213823 ANDA Baxter Healthcare Corporation 10019-991 10019-991-01 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-991-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
BORTEZOMIB bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 213823 ANDA Bamboo US Bidco LCC 83703-532 83703-532-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83703-532-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:May 2, 2022TE:APRLD:No

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