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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
GANCICLOVIR SODIUM | 076222 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2003/07/16 | 2003/07/16 | HIKMA | Prescription |
GANCICLOVIR SODIUM | 090658 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2010/06/21 | 2010/06/21 | FRESENIUS KABI USA | Prescription |
GANCICLOVIR SODIUM | 202624 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2013/09/18 | 2013/09/18 | AM REGENT | Discontinued |
GANCICLOVIR SODIUM | 204950 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2016/12/06 | 2016/12/06 | ENDO OPERATIONS | Prescription |
GANCICLOVIR SODIUM | 204560 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2017/11/17 | 2017/11/17 | STERISCIENCE SPECLTS | Discontinued |
GANCICLOVIR SODIUM | 207645 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | Yes | 2017/12/08 | 2017/12/08 | PHARMASCIENCE INC | Prescription |
GANCICLOVIR SODIUM | 204204 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2018/11/08 | 2018/11/08 | SLATE RUN PHARMA | Prescription |
GANCICLOVIR SODIUM | 212001 | 001 | ANDA | GANCICLOVIR SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No | 2019/06/20 | 2019/06/20 | CUSTOPHARM INC | Discontinued |