Details for New Drug Application (NDA): 208392
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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 208392
Tradename: | BORTEZOMIB |
Applicant: | Pharmascience Inc |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208392
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 208392
Suppliers and Packaging for NDA: 208392
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 208392 | ANDA | Sagent Pharmaceuticals | 25021-244 | 25021-244-10 | 1 VIAL in 1 CARTON (25021-244-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 208392 | ANDA | Pharmascience Inc. | 51817-586 | 51817-586-01 | 1 VIAL in 1 CARTON (51817-586-01) / 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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