Details for New Drug Application (NDA): 205533
✉ Email this page to a colleague
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 205533
Tradename: | BORTEZOMIB |
Applicant: | Apotex |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205533
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 205533
Suppliers and Packaging for NDA: 205533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 205533 | ANDA | Apotex Corp | 60505-6050 | 60505-6050-4 | 1 VIAL in 1 CARTON (60505-6050-4) / 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 |
Complete Access Available with Subscription