Details for New Drug Application (NDA): 209622
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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 209622
Tradename: | BORTEZOMIB |
Applicant: | Msn |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209622
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 209622
Suppliers and Packaging for NDA: 209622
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 209622 | ANDA | BluePoint Laboratories | 68001-541 | 68001-541-36 | 1 VIAL, SINGLE-USE in 1 CARTON (68001-541-36) / 3.5 mL in 1 VIAL, SINGLE-USE |
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 209622 | ANDA | Novadoz Pharmaceuticals LLC | 72205-183 | 72205-183-01 | 1 VIAL, SINGLE-USE in 1 CARTON (72205-183-01) / 3.5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 3.5MG/VIAL | ||||
Approval Date: | Jul 26, 2022 | TE: | AP | RLD: | No |
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