| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ESMOLOL HYDROCHLORIDE | 076323 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2004/08/10 | 2004/08/10 | HIKMA | Prescription |
| ESMOLOL HYDROCHLORIDE | 076474 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2005/05/02 | 2005/05/02 | MYLAN INSTITUTIONAL | Prescription |
| ESMOLOL HYDROCHLORIDE | 076573 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2005/05/02 | 2005/05/02 | FRESENIUS KABI USA | Discontinued |
| ESMOLOL HYDROCHLORIDE | 076573 | 002 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML | No | No | 2005/05/02 | 2023/08/23 | FRESENIUS KABI USA | Discontinued |
| ESMOLOL HYDROCHLORIDE | 201126 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2015/02/20 | 2015/02/20 | AM REGENT | Discontinued |
| ESMOLOL HYDROCHLORIDE | 205520 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2015/07/23 | 2015/07/23 | EUGIA PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | 205703 | 001 | NDA | ESMOLOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2.5GM/250ML (10MG/ML) | Yes | Yes | 2016/04/07 | 2016/04/07 | HQ SPCLT PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER | 205703 | 002 | NDA | ESMOLOL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2GM/100ML (20MG/ML) | Yes | Yes | 2016/04/07 | 2016/04/07 | HQ SPCLT PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE | 206608 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/100ML | No | No | 2018/06/08 | 2018/06/08 | MYLAN LABS LTD | Prescription |
| ESMOLOL HYDROCHLORIDE | 206608 | 002 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/100ML | No | No | 2018/06/08 | 2018/06/08 | MYLAN LABS LTD | Prescription |
| ESMOLOL HYDROCHLORIDE | 207107 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/100ML | No | No | 2018/06/08 | 2018/06/08 | SAGENT PHARMS INC | Prescription |
| ESMOLOL HYDROCHLORIDE | 207107 | 002 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/100ML | No | No | 2018/06/08 | 2018/06/08 | SAGENT PHARMS INC | Prescription |
| ESMOLOL HYDROCHLORIDE | 208538 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No | 2019/08/14 | 2019/08/14 | GLAND PHARMA LTD | Prescription |
| ESMOLOL HYDROCHLORIDE | 216244 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/100ML | No | No | 2022/03/21 | 2022/03/21 | EUGIA PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE | 216244 | 002 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/100ML | No | No | 2022/03/21 | 2022/03/21 | EUGIA PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE | 214172 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/100ML | No | No | 2022/12/02 | 2022/12/02 | HQ SPCLT PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE | 214172 | 002 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/100ML | No | No | 2022/12/02 | 2022/12/02 | HQ SPCLT PHARMA | Prescription |
| ESMOLOL HYDROCHLORIDE | 216603 | 001 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 1GM/100ML | No | No | 2022/12/13 | 2022/12/13 | AMNEAL | Prescription |
| ESMOLOL HYDROCHLORIDE | 216603 | 002 | ANDA | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 2GM/100ML | No | No | 2022/12/13 | 2022/12/13 | AMNEAL | Prescription |