Details for New Drug Application (NDA): 203654
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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 203654
Tradename: | BORTEZOMIB |
Applicant: | Sandoz |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203654
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 203654
Suppliers and Packaging for NDA: 203654
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 203654 | ANDA | Sandoz Inc | 0781-3258 | 0781-3258-70 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3258-70) |
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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