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 | 074739 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 1998/11/30 | 1998/11/30 | TEVA PHARMS | Prescription |
AMIODARONE HYDROCHLORIDE | 075315 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 1998/12/23 | 1998/12/23 | UPSHER SMITH LABS | Discontinued |
AMIODARONE HYDROCHLORIDE | 075315 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 1998/12/23 | 2000/06/30 | UPSHER SMITH LABS | Discontinued |
AMIODARONE HYDROCHLORIDE | 075188 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 1999/02/24 | 1999/02/24 | NORVIUM BIOSCIENCE | Discontinued |
AMIODARONE HYDROCHLORIDE | 074895 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 1999/04/16 | 1999/04/16 | TEVA | Discontinued |
AMIODARONE HYDROCHLORIDE | 075389 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No | 2001/01/25 | 2001/01/25 | DR REDDYS LABS SA | Prescription |
AMIODARONE HYDROCHLORIDE | 075389 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2001/01/25 | 2017/12/28 | DR REDDYS LABS SA | Prescription |
AMIODARONE HYDROCHLORIDE | 075389 | 003 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2001/01/25 | 2017/12/28 | DR REDDYS LABS SA | Prescription |
AMIODARONE HYDROCHLORIDE | 075424 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | Yes | 2001/03/30 | 2001/03/30 | TARO | Prescription |
AMIODARONE HYDROCHLORIDE | 075424 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No | 2001/03/30 | 2002/12/18 | TARO | Prescription |
AMIODARONE HYDROCHLORIDE | 075761 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | Yes | 2002/10/15 | 2002/10/15 | FRESENIUS KABI USA | Prescription |
AMIODARONE HYDROCHLORIDE | 076018 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2002/10/15 | 2002/10/15 | BEDFORD | Discontinued |
AMIODARONE HYDROCHLORIDE | 076088 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2002/10/15 | 2002/10/15 | BEN VENUE | Discontinued |
AMIODARONE HYDROCHLORIDE | 076108 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2002/10/15 | 2002/10/15 | HOSPIRA | Discontinued |
AMIODARONE HYDROCHLORIDE | 076217 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | Yes | 2002/10/15 | 2002/10/15 | MYLAN INSTITUTIONAL | Prescription |
AMIODARONE HYDROCHLORIDE | 075955 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2002/10/18 | 2002/10/18 | HOSPIRA | Discontinued |
AMIODARONE HYDROCHLORIDE | 076299 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2002/10/24 | 2002/10/24 | BEDFORD LABS | Discontinued |
AMIODARONE HYDROCHLORIDE | 076362 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No | 2002/11/29 | 2002/11/29 | TARO | Prescription |
AMIODARONE HYDROCHLORIDE | 076362 | 002 | ANDA | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No | 2002/11/29 | 2003/12/02 | TARO | Prescription |
AMIODARONE HYDROCHLORIDE | 076394 | 001 | ANDA | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No | 2003/04/25 | 2003/04/25 | PAR STERILE PRODUCTS | Discontinued |