Details for New Drug Application (NDA): 213823
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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 213823
Tradename: | BORTEZOMIB |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213823
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 213823
Suppliers and Packaging for NDA: 213823
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 213823 | ANDA | Baxter Healthcare Corporation | 10019-991 | 10019-991-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-991-01) / 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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