BIVALIRUDIN Pharmacologic Class Indexing
- Class set ID
- 19ac5cc2-97bd-4800-bc7a-48226b10bfba
- Version
- 2
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Civica, Inc. | 20250910 | 2 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Fresenius Kabi USA, LLC | 20250827 | 4 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Fresenius Kabi USA, LLC | 20250508 | 5 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Mylan Institutional LLC | 20250324 | 8 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 20241223 | 5 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Eugia US LLC | EUGIA PHARMA SPECIALITIES LIMITED | 20241210 | 8 |
| These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION. BIVALIRUDIN injection, for intravenous use Initial U.S. Approval: 2000 | Endo USA, Inc. | Bachem AG | 20241029 | 2 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Accord Healthcare, Inc. | Intas Pharmaceuticals Limited | 20240815 | 7 |
| These highlights do not include all the information needed to use BIVALIRUDIN INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION. BIVALIRUDIN injection, for intravenous use Initial U.S. Approval: 2000 | MAIA Pharmaceuticals, Inc. | Gland Pharma Limited | 20240527 | 1 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Meitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. | 20240404 | 1 |
| BIVALIRUDIN for injection, for intravenous use (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC) These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 2000 | Pharma Packaging Solutions, LLC dba Tjoapack LLC | Patheon Italia S.p.A | 20240307 | 1 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Avenacy, Inc. | 20231020 | 1 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. Initial U.S. Approval: 2000 | Slate Run Pharmaceuticals, LLC | Hainan Poly Pharm. Co. Ltd. | 20210609 | 1 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Meitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. | 20210608 | 2 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Sandoz Inc | 20190930 | 4 |
| These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION. BIVALIRUDIN for injection, for intravenous use Initial U.S. Approval: 2000 | Dr. Reddy's Laboratories Limited | Gland Pharma Limited | 20190716 | 10 |