Details for New Drug Application (NDA): 209659
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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 209659
Tradename: | BORTEZOMIB |
Applicant: | Fresenius Kabi Usa |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209659
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 209659
Suppliers and Packaging for NDA: 209659
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 209659 | ANDA | Fresenius Kabi USA, LLC | 63323-821 | 63323-821-10 | 1 VIAL, SINGLE-USE in 1 CARTON (63323-821-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE |
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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