Details for New Drug Application (NDA): 209191
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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 209191
Tradename: | BORTEZOMIB |
Applicant: | Hospira |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209191
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 209191
Suppliers and Packaging for NDA: 209191
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | POWDER;INTRAVENOUS, SUBCUTANEOUS | 209191 | NDA | Hospira, Inc. | 0409-1703 | 0409-1703-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1703-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
BORTEZOMIB | bortezomib | POWDER;INTRAVENOUS, SUBCUTANEOUS | 209191 | NDA | Hospira, Inc. | 0409-1704 | 0409-1704-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1704-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, SUBCUTANEOUS | Strength | 1MG/VIAL | ||||
Approval Date: | May 2, 2022 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, SUBCUTANEOUS | Strength | 2.5MG/VIAL | ||||
Approval Date: | May 2, 2022 | TE: | RLD: | Yes |
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