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-five 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 |
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 |
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 213823 | ANDA | Bamboo US Bidco LCC | 83703-532 | 83703-532-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83703-532-01) / 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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