Details for New Drug Application (NDA): 210204
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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 210204
Tradename: | BORTEZOMIB |
Applicant: | Zydus Pharms |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210204
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 210204
Suppliers and Packaging for NDA: 210204
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 210204 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1411 | 70710-1411-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1411-1) / 3.5 mL in 1 VIAL, SINGLE-DOSE |
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 210204 | ANDA | Zydus Lifesciences Limited | 70771-1708 | 70771-1708-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70771-1708-1) / 3.5 mL 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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