Details for New Drug Application (NDA): 205533
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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 205533
Tradename: | BORTEZOMIB |
Applicant: | Apotex |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205533
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 205533
Suppliers and Packaging for NDA: 205533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 205533 | ANDA | Apotex Corp | 60505-6050 | 60505-6050-4 | 1 VIAL in 1 CARTON (60505-6050-4) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 3.5MG/VIAL | ||||
Approval Date: | May 2, 2022 | TE: | AP | RLD: | No |
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