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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CISPLATIN | 018057 | 002 | NDA | CISPLATIN | INJECTABLE;INJECTION | 50MG/VIAL | Yes | Yes | 1978/12/19 | Approved Prior to Jan 1, 1982 | HQ SPCLT PHARMA | Prescription |
CISPLATIN | 018057 | 004 | NDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | Yes | No | 1978/12/19 | 1988/11/08 | HQ SPCLT PHARMA | Prescription |
CISPLATIN | 074735 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | Yes | 1999/07/16 | 1999/07/16 | FRESENIUS KABI USA | Prescription |
CISPLATIN | 074656 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2000/05/16 | 2000/05/16 | PHARMACHEMIE BV | Prescription |
CISPLATIN | 074814 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2000/05/16 | 2000/05/16 | TEVA PHARMS USA | Discontinued |
CISPLATIN | 075036 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2000/11/07 | 2000/11/07 | HIKMA | Prescription |
CISPLATIN | 074713 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 10MG/VIAL | No | No | 2000/11/14 | 2000/11/14 | BEDFORD | Discontinued |
CISPLATIN | 074713 | 002 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 50MG/VIAL | No | No | 2000/11/14 | 2000/11/14 | BEDFORD | Discontinued |
CISPLATIN | 091062 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2012/04/18 | 2012/04/18 | NORVIUM BIOSCIENCE | Discontinued |
CISPLATIN | 206774 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2015/08/18 | 2015/08/18 | ACCORD HLTHCARE | Prescription |
CISPLATIN | 207323 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2017/03/17 | 2017/03/17 | GLAND PHARMA LTD | Prescription |
CISPLATIN | 218868 | 001 | ANDA | CISPLATIN | INJECTABLE;INJECTION | 1MG/ML | No | No | 2024/05/10 | 2024/05/10 | QILU | Prescription |