Details for New Drug Application (NDA): 213078
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NDA 213078 describes BIVALIRUDIN, which is a drug marketed by Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, and Baxter Hlthcare Corp, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the BIVALIRUDIN profile page.
The generic ingredient in BIVALIRUDIN is bivalirudin. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
The generic ingredient in BIVALIRUDIN is bivalirudin. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
Summary for 213078
| Tradename: | BIVALIRUDIN |
| Applicant: | Slate Run Pharma |
| Ingredient: | bivalirudin |
| Patents: | 0 |
Pharmacology for NDA: 213078
| Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 213078
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 213078 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-025 | 70436-025-80 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80) |
| BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 213078 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-025 | 70436-025-82 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON (70436-025-82) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/VIAL | ||||
| Approval Date: | May 28, 2021 | TE: | AP | RLD: | No | ||||
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