Details for New Drug Application (NDA): 215331
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The generic ingredient in BORTEZOMIB is bortezomib. There are twenty drug master file entries for this compound. Twenty-one 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: | 2 |
Formulation / Manufacturing: | see details |
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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