Details for New Drug Application (NDA): 215011
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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 215011
Tradename: | BORTEZOMIB |
Applicant: | Jiangsu Hansoh Pharm |
Ingredient: | bortezomib |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215011
Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 215011
Suppliers and Packaging for NDA: 215011
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 215011 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9098 | 0143-9098-01 | 1 VIAL in 1 CARTON (0143-9098-01) / 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: | Jul 26, 2022 | TE: | AP | RLD: | No |
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