| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AMIODARONE HYDROCHLORIDE | 076163 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2003/09/05 | 2003/09/05 | DR REDDYS | Discontinued |
| AMIODARONE HYDROCHLORIDE | 021594 | 001 | NDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2004/02/04 | 2004/02/04 | INTL MEDICATION SYS | Discontinued |
| AMIODARONE HYDROCHLORIDE | 077069 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2005/04/08 | 2005/04/08 | CHARTWELL RX | Prescription |
| AMIODARONE HYDROCHLORIDE | 077069 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2005/04/08 | 2005/04/08 | CHARTWELL RX | Prescription |
| AMIODARONE HYDROCHLORIDE | 077069 | 003 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2005/04/08 | 2016/10/04 | CHARTWELL RX | Prescription |
| AMIODARONE HYDROCHLORIDE | 077161 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | Yes | 2005/04/20 | 2005/04/20 | GLAND PHARMA LTD | Prescription |
| AMIODARONE HYDROCHLORIDE | 076232 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2006/07/05 | 2006/07/05 | EPIC PHARMA LLC | Discontinued |
| AMIODARONE HYDROCHLORIDE | 077234 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2008/02/25 | 2008/02/25 | HIKMA FARMACEUTICA | Prescription |
| AMIODARONE HYDROCHLORIDE | 079029 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2008/09/16 | 2008/09/16 | ZYDUS PHARMS USA INC | Prescription |
| AMIODARONE HYDROCHLORIDE | 079029 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2008/09/16 | 2023/01/06 | ZYDUS PHARMS USA INC | Prescription |
| AMIODARONE HYDROCHLORIDE | 079029 | 003 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2008/09/16 | 2023/01/06 | ZYDUS PHARMS USA INC | Prescription |
| AMIODARONE HYDROCHLORIDE | 077610 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2008/10/30 | 2008/10/30 | ACELLA | Prescription |
| AMIODARONE HYDROCHLORIDE | 077834 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2008/10/30 | 2008/10/30 | ACELLA | Prescription |
| AMIODARONE HYDROCHLORIDE | 078578 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2008/11/06 | 2008/11/06 | RUBICON | Prescription |
| AMIODARONE HYDROCHLORIDE | 078578 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2008/11/06 | 2021/02/26 | RUBICON | Prescription |
| AMIODARONE HYDROCHLORIDE | 078578 | 003 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2008/11/06 | 2021/02/26 | RUBICON | Prescription |
| AMIODARONE HYDROCHLORIDE | 203884 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2013/11/25 | 2013/11/25 | HOSPIRA | Discontinued |
| AMIODARONE HYDROCHLORIDE | 203885 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2013/11/25 | 2013/11/25 | HOSPIRA | Discontinued |
| AMIODARONE HYDROCHLORIDE | 204742 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2016/06/03 | 2016/06/03 | AUROBINDO PHARMA LTD | Prescription |
| AMIODARONE HYDROCHLORIDE | 204550 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2017/10/25 | 2017/10/25 | EUGIA PHARMA | Discontinued |