Details for New Drug Application (NDA): 210824
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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 210824
Tradename: | BORTEZOMIB |
Applicant: | Qilu Pharm Hainan |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210824
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 210824
Suppliers and Packaging for NDA: 210824
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 210824 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-484 | 50742-484-01 | 1 VIAL in 1 CARTON (50742-484-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 210824 | ANDA | BluePoint Laboratories | 68001-540 | 68001-540-36 | 1 VIAL in 1 CARTON (68001-540-36) / 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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