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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
EPIRUBICIN HYDROCHLORIDE | 050807 | 001 | NDA | EPIRUBICIN HYDROCHLORIDE | POWDER;INTRAVENOUS | 50MG/VIAL | No | No | 2006/09/15 | 2006/09/15 | HOSPIRA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 050807 | 002 | NDA | EPIRUBICIN HYDROCHLORIDE | POWDER;INTRAVENOUS | 200MG/VIAL | No | No | 2006/09/15 | 2006/09/15 | HOSPIRA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065343 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/5ML (2MG/ML) | No | No | 2007/04/19 | 2007/04/19 | HOSPIRA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065343 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/04/19 | 2007/04/19 | HOSPIRA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065343 | 003 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 150MG/75ML (2MG/ML) | No | No | 2007/04/19 | 2007/04/19 | HOSPIRA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065343 | 004 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/04/19 | 2007/04/19 | HOSPIRA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065289 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/06/27 | 2007/06/27 | HIKMA | Prescription |
EPIRUBICIN HYDROCHLORIDE | 065289 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/06/27 | 2007/06/27 | HIKMA | Prescription |
EPIRUBICIN HYDROCHLORIDE | 065331 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/08/09 | 2007/08/09 | IMPAX LABS INC | Prescription |
EPIRUBICIN HYDROCHLORIDE | 065331 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/08/09 | 2007/08/09 | IMPAX LABS INC | Prescription |
EPIRUBICIN HYDROCHLORIDE | 065411 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/08/20 | 2007/08/20 | FRESENIUS KABI USA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065411 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/08/20 | 2007/08/20 | FRESENIUS KABI USA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065408 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/5ML (2MG/ML) | No | No | 2007/10/15 | 2007/10/15 | FRESENIUS KABI USA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065408 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/10/15 | 2007/10/15 | FRESENIUS KABI USA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065408 | 003 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 150MG/75ML (2MG/ML) | No | No | 2007/10/15 | 2007/10/15 | FRESENIUS KABI USA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065408 | 004 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/10/15 | 2007/10/15 | FRESENIUS KABI USA | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065361 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/10/22 | 2007/10/22 | CIPLA LTD | Prescription |
EPIRUBICIN HYDROCHLORIDE | 065361 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/10/22 | 2007/10/22 | CIPLA LTD | Prescription |
EPIRUBICIN HYDROCHLORIDE | 065371 | 001 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | No | No | 2007/11/28 | 2007/11/28 | NORVIUM BIOSCIENCE | Discontinued |
EPIRUBICIN HYDROCHLORIDE | 065371 | 002 | ANDA | EPIRUBICIN HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | No | No | 2007/11/28 | 2007/11/28 | NORVIUM BIOSCIENCE | Discontinued |