| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TOPOTECAN HYDROCHLORIDE | 091089 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2010/11/29 | 2010/11/29 | FRESENIUS KABI USA | Prescription |
| TOPOTECAN HYDROCHLORIDE | 091376 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2010/11/29 | 2010/11/29 | FRESENIUS KABI USA | Discontinued |
| TOPOTECAN HYDROCHLORIDE | 091199 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2010/12/01 | 2010/12/01 | TEYRO LABS | Prescription |
| TOPOTECAN HYDROCHLORIDE | 090620 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2010/12/02 | 2010/12/02 | ACTAVIS TOTOWA | Prescription |
| TOPOTECAN HYDROCHLORIDE | 091284 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2011/01/26 | 2011/01/26 | SAGENT PHARMS | Prescription |
| TOPOTECAN HYDROCHLORIDE | 200582 | 001 | NDA | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | Yes | Yes | 2011/02/02 | 2011/02/02 | HOSPIRA INC | Prescription |
| TOPOTECAN HYDROCHLORIDE | 201191 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2011/03/09 | 2011/03/09 | DR REDDYS LABS LTD | Prescription |
| TOPOTECAN HYDROCHLORIDE | 201166 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2012/08/08 | 2012/08/08 | MEITHEAL | Discontinued |
| TOPOTECAN HYDROCHLORIDE | 091542 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2012/08/28 | 2012/08/28 | RISING | Discontinued |
| TOPOTECAN HYDROCHLORIDE | 022453 | 001 | NDA | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | No | No | 2012/12/20 | 2012/12/20 | MEITHEAL | Discontinued |
| TOPOTECAN HYDROCHLORIDE | 202351 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2013/06/26 | 2013/06/26 | ACCORD HLTHCARE | Prescription |
| TOPOTECAN HYDROCHLORIDE | 202203 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2013/08/29 | 2013/08/29 | SUN PHARM INDS LTD | Discontinued |
| TOPOTECAN HYDROCHLORIDE | 206962 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/VIAL | No | No | 2016/11/30 | 2016/11/30 | NOVAST LABS | Prescription |
| TOPOTECAN HYDROCHLORIDE | 204406 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | No | No | 2017/07/06 | 2017/07/06 | ACCORD HLTHCARE | Prescription |
| TOPOTECAN HYDROCHLORIDE | 204406 | 002 | ANDA | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | No | No | 2017/07/06 | 2017/07/06 | ACCORD HLTHCARE | Prescription |
| TOPOTECAN HYDROCHLORIDE | 206074 | 001 | ANDA | TOPOTECAN HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | No | No | 2017/11/24 | 2017/11/24 | DASH PHARMS | Discontinued |