Details for New Drug Application (NDA): 212958
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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 212958
Tradename: | BORTEZOMIB |
Applicant: | Meitheal |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212958
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 212958
Suppliers and Packaging for NDA: 212958
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 212958 | ANDA | BluePoint Laboratories | 68001-534 | 68001-534-36 | 1 VIAL in 1 CARTON (68001-534-36) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 212958 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-118 | 71288-118-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-118-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 3.5MG/VIAL | ||||
Approval Date: | Jul 26, 2022 | TE: | AP | RLD: | No |
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