Details for New Drug Application (NDA): 212825
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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 212825
Tradename: | BORTEZOMIB |
Applicant: | Eugia Pharma |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212825
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 212825
Suppliers and Packaging for NDA: 212825
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 212825 | ANDA | Eugia US LLC | 55150-337 | 55150-337-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-01) / 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: | May 2, 2022 | TE: | AP | RLD: | No |
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