Details for New Drug Application (NDA): 215331
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NDA 215331 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 215331
| Tradename: | BORTEZOMIB |
| Applicant: | Maia Pharms Inc |
| Ingredient: | bortezomib |
| Patents: | 3 |
Pharmacology for NDA: 215331
| Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 215331
Suppliers and Packaging for NDA: 215331
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS | 215331 | NDA | MAIA Pharmaceuticals, Inc. | 70511-161 | 70511-161-05 | 1 INJECTION in 1 VIAL, SINGLE-DOSE (70511-161-05) |
| BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS | 215331 | NDA | MAIA Pharmaceuticals, Inc. | 70511-162 | 70511-162-02 | 1 INJECTION in 1 VIAL, SINGLE-DOSE (70511-162-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3.5MG/3.5ML (1MG/ML) | ||||
| Approval Date: | Jul 27, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 23, 2042 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 23, 2042 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 23, 2042 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA | ||||||||
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