美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TOPOTECAN"
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 200199 001 NDA TOPOTECAN HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/02/25 2011/02/25 SANDOZ INC Discontinued
TOPOTECAN 200199 002 NDA TOPOTECAN HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/02/25 2011/02/25 SANDOZ INC Discontinued
TOPOTECAN 200199 003 NDA TOPOTECAN HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2011/02/25 2011/02/25 SANDOZ INC Discontinued
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 Prescription
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
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