药品注册申请号:206962
申请类型:ANDA (仿制药申请)
申请人:NOVAST LABS
申请人全名:NOVAST LABORATORIES LTD
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL No No AP 2016/11/30 2016/11/30 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2024/02/23 SUPPL-1(补充) Approval Labeling STANDARD
2016/11/30 ORIG-1(原始申请) Approval STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:TOPOTECAN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 4MG BASE/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
020671 001 NDA HYCAMTIN TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription Yes Yes AP 1996/05/28 SANDOZ
091089 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2010/11/29 FRESENIUS KABI USA
091199 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2010/12/01 TEYRO LABS
090620 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2010/12/02 ACTAVIS TOTOWA
091284 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2011/01/26 SAGENT PHARMS
201191 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2011/03/09 DR REDDYS LABS LTD
202351 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2013/06/26 ACCORD HLTHCARE
206962 001 ANDA TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/VIAL Prescription No No AP 2016/11/30 NOVAST LABS
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