Details for New Drug Application (NDA): 210824
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NDA 210824 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Mylan Labs Ltd, Pharmascience Inc, Qilu Pharm Hainan, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Waverley Pharma Inc, Zydus Pharms, and Maia Pharms Inc, and is included in twenty-three NDAs. It is available from nineteen suppliers. There are three 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 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 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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