Details for New Drug Application (NDA): 208374
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NDA 208374 describes BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. Additional details are available on the BIVALIRUDIN IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in BIVALIRUDIN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 208374
| Tradename: | BIVALIRUDIN IN 0.9% SODIUM CHLORIDE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | bivalirudin |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/100ML (5MG/ML) | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
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