Details for New Drug Application (NDA): 215441
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NDA 215441 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.
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 215441
| Tradename: | BORTEZOMIB |
| Applicant: | Accord Hlthcare |
| Ingredient: | bortezomib |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215441
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 26, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 26, 2022 | TE: | RLD: | Yes | |||||
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