Details for New Drug Application (NDA): 212782
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NDA 212782 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Norvium Bioscience, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Zydus Pharms, Maia Pharms Inc, and Shilpa, and is included in twenty-five NDAs. It is available from twenty-three 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-four 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-four suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
Summary for 212782
| Tradename: | BORTEZOMIB |
| Applicant: | Shilpa |
| Ingredient: | bortezomib |
| Patents: | 0 |
Pharmacology for NDA: 212782
| Mechanism of Action | Proteasome Inhibitors |
Medical Subject Heading (MeSH) Categories for 212782
Suppliers and Packaging for NDA: 212782
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 212782 | NDA | Shilpa Medicare Limited | 63759-3032 | 63759-3032-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE |
| BORTEZOMIB | bortezomib | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 212782 | NDA | Amneal Pharmaceuticals LLC | 70121-2484 | 70121-2484-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2484-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Strength | 3.5MG/1.4ML (2.5MG/ML) | ||||
| Approval Date: | Aug 26, 2024 | TE: | RLD: | Yes | |||||
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