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 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: | ⤷ Try a Trial | Patent Expiration: | Sep 23, 2042 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 23, 2042 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA | ||||||||
Patent: | ⤷ Try a Trial | 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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