| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CALCIUM GLUCONATE | 208418 | 001 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | Yes | Yes | 2017/06/15 | 2017/06/15 | FRESENIUS KABI USA | Prescription |
| CALCIUM GLUCONATE | 208418 | 002 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 5GM/50ML (100MG/ML) | Yes | Yes | 2017/06/15 | 2017/06/15 | FRESENIUS KABI USA | Prescription |
| CALCIUM GLUCONATE | 208418 | 003 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 10GM/100ML (100MG/ML) | Yes | Yes | 2017/06/15 | 2017/06/15 | FRESENIUS KABI USA | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 208418 | 004 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/50ML (20MG/ML) | Yes | Yes | 2017/06/15 | 2021/06/17 | FRESENIUS KABI USA | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 208418 | 005 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 2GM/100ML (20MG/ML) | Yes | Yes | 2017/06/15 | 2021/06/17 | FRESENIUS KABI USA | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 210906 | 001 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/50ML (20MG/ML) | Yes | Yes | 2018/10/29 | 2018/10/29 | HQ SPCLT PHARMA | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 210906 | 002 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 2GM/100ML (20MG/ML) | Yes | Yes | 2018/10/29 | 2018/10/29 | HQ SPCLT PHARMA | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 210906 | 003 | NDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | Yes | Yes | 2018/10/29 | 2021/06/04 | HQ SPCLT PHARMA | Prescription |
| CALCIUM GLUCONATE | 213071 | 001 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | No | No | 2022/10/14 | 2022/10/14 | NIVAGEN PHARMS INC | Prescription |
| CALCIUM GLUCONATE | 213071 | 002 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 5GM/50ML (100MG/ML) | No | No | 2022/10/14 | 2023/10/19 | NIVAGEN PHARMS INC | Prescription |
| CALCIUM GLUCONATE | 216541 | 001 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 10GM/100ML (100MG/ML) | No | No | 2023/08/21 | 2023/08/21 | B BRAUN MEDICAL INC | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 217174 | 001 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 1GM/50ML (20MG/ML) | No | No | 2023/09/05 | 2023/09/05 | AMNEAL | Prescription |
| CALCIUM GLUCONATE IN SODIUM CHLORIDE | 217174 | 002 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 2GM/100ML (20MG/ML) | No | No | 2023/09/05 | 2023/09/05 | AMNEAL | Prescription |
| CALCIUM GLUCONATE | 217689 | 001 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 5GM/50ML (100MG/ML) | No | No | 2023/10/19 | 2023/10/19 | SOMERSET | Prescription |
| CALCIUM GLUCONATE | 217689 | 002 | ANDA | CALCIUM GLUCONATE | SOLUTION;INTRAVENOUS | 10GM/100ML (100MG/ML) | No | No | 2023/10/19 | 2023/10/19 | SOMERSET | Prescription |