药品注册申请号：208718
申请类型：ANDA (仿制药申请)
申请人：SHILPA
申请人全名：SHILPA MEDICARE 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 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) No No AP 2018/12/28 2018/12/28 Prescription
002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) No No AP 2018/12/28 Prescription
003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 300MG/15ML (20MG/ML) No No AP 2019/08/16 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
2022/10/28 SUPPL-10（补充） Approval Labeling STANDARD
2022/10/28 SUPPL-8（补充） Approval Labeling STANDARD
2020/06/12 SUPPL-5（补充） Approval Labeling STANDARD
2018/12/28 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
无
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
无
与本品治疗等效的药品
活性成分:IRINOTECAN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:40MG/2ML (20MG/ML) 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
020571 001 NDA CAMPTOSAR IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription Yes Yes AP 1996/06/14 PFIZER INC
077776 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2008/02/27 FRESENIUS KABI USA
077915 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2008/02/27 HOSPIRA
078589 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2008/02/27 ACTAVIS TOTOWA
090101 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Discontinued No No AP 2008/02/27 TEVA PHARMS USA
079068 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2008/11/21 ACCORD HLTHCARE
078753 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2008/12/24 WEST-WARD PHARMS INT
090016 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Discontinued No No AP 2009/01/28 HISUN PHARM HANGZHOU
090726 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2009/09/16 EPIC PHARMA LLC
091032 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2010/12/20 HIKMA FARMACEUTICA
090393 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2011/05/13 ZENNOVA
090675 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2011/12/16 HENGRUI PHARMA
203380 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2016/05/03 QILU PHARM HAINAN
206935 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2017/05/26 NOVAST LABS
203054 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2017/08/31 INTAS PHARMS USA
208718 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2018/12/28 SHILPA
212993 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2019/11/18 GLAND PHARMA LTD
213278 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) Prescription No No AP 2020/11/02 EUGIA PHARMA
活性成分:IRINOTECAN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:100MG/5ML (20MG/ML) 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
020571 002 NDA CAMPTOSAR IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription Yes Yes AP 1996/06/14 PFIZER INC
077776 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2008/02/27 FRESENIUS KABI USA
077915 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2008/02/27 HOSPIRA
078589 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2008/02/27 ACTAVIS TOTOWA
090101 003 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Discontinued No No AP 2008/02/27 TEVA PHARMS USA
079068 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2008/11/21 ACCORD HLTHCARE
078753 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2008/12/24 WEST-WARD PHARMS INT
090016 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Discontinued No No AP 2009/01/28 HISUN PHARM HANGZHOU
090726 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2009/09/16 EPIC PHARMA LLC
091032 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2010/12/20 HIKMA FARMACEUTICA
090393 003 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2011/05/13 ZENNOVA
090675 001 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2011/12/16 HENGRUI PHARMA
203380 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2016/05/03 QILU PHARM HAINAN
206935 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2017/05/26 NOVAST LABS
203054 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2017/08/31 INTAS PHARMS USA
208718 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2018/12/28 SHILPA
212993 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2019/11/18 GLAND PHARMA LTD
213278 002 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) Prescription No No AP 2020/11/02 EUGIA PHARMA
活性成分:IRINOTECAN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:300MG/15ML (20MG/ML) 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
020571 003 NDA CAMPTOSAR IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 300MG/15ML (20MG/ML) Prescription Yes Yes AP 2010/08/05 PFIZER INC
203380 003 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 300MG/15ML (20MG/ML) Prescription No No AP 2016/05/03 QILU PHARM HAINAN
208718 003 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 300MG/15ML (20MG/ML) Prescription No No AP 2019/08/16 SHILPA
213278 003 ANDA IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 300MG/15ML (20MG/ML) Prescription No No AP 2020/11/02 EUGIA PHARMA
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