Details for New Drug Application (NDA): 216528
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NDA 216528 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Caplin One Labs, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Pharmascience Inc, Pharmobedient, Qilu Pharm Hainan, Reliance Life Sci, Scinopharm Taiwan, Shuangcheng, Teva Pharms Usa, Vilin Bio Med, Zydus Pharms, Gland, Maia Pharms Inc, and Shilpa, and is included in twenty-eight NDAs. It is available from twenty-four suppliers. There are four patents protecting this drug. Additional details are available on the BORTEZOMIB profile page.
The generic ingredient in BORTEZOMIB is bortezomib. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
The generic ingredient in BORTEZOMIB is bortezomib. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
Summary for 216528
| Tradename: | BORTEZOMIB |
| Applicant: | Shuangcheng |
| Ingredient: | bortezomib |
| Patents: | 0 |
Pharmacology for NDA: 216528
| Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 216528
Suppliers and Packaging for NDA: 216528
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 216528 | ANDA | Ningbo Shuangcheng Pharmaceutical Co., Ltd. | 75007-501 | 75007-501-31 | 10 VIAL in 1 CARTON (75007-501-31) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
| BORTEZOMIB | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 216528 | ANDA | Ningbo Shuangcheng Pharmaceutical Co., Ltd. | 75007-501 | 75007-501-32 | 1 VIAL in 1 CARTON (75007-501-32) / 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: | Dec 17, 2025 | TE: | AP | RLD: | No | ||||
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