药品注册申请号:211269
申请类型:ANDA (仿制药申请)
申请人:FRESENIUS KABI USA
申请人全名:FRESENIUS KABI USA LLC
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 MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL No No AP 2024/04/05 2024/04/05 Prescription
002 MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL No No AP 2024/04/05 Prescription
003 MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL No No AP 2024/04/05 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
2024/04/05 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:MITOMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:5MG/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
064144 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No Yes AP 1998/04/30 ACCORD HLTHCARE
064180 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No No AP 1999/12/23 HIKMA
202670 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No No AP 2017/10/13 RK PHARMA
215687 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No No AP 2021/10/20 GLAND PHARMA LTD
214505 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No No AP 2022/09/08 MEITHEAL
216732 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No No AP 2023/10/30 EUGIA PHARMA
211269 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 5MG/VIAL Prescription No No AP 2024/04/05 FRESENIUS KABI USA
活性成分:MITOMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/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
064117 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 1995/04/19 HIKMA
064144 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No Yes AP 1998/04/30 ACCORD HLTHCARE
064180 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 1999/12/23 HIKMA
202670 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2017/10/13 RK PHARMA
215687 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2021/10/20 GLAND PHARMA LTD
214505 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2022/09/08 MEITHEAL
216732 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2023/10/30 EUGIA PHARMA
211269 002 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2024/04/05 FRESENIUS KABI USA
活性成分:MITOMYCIN 剂型/给药途径:INJECTABLE;INJECTION 规格:40MG/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
064117 003 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No No AP 1999/06/02 HIKMA
064144 003 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No Yes AP 2009/08/11 ACCORD HLTHCARE
203386 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No No AP 2017/10/13 RK PHARMA
214504 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No No AP 2022/09/06 MEITHEAL
216648 001 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No No AP 2022/11/22 GLAND PHARMA LTD
216732 003 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No No AP 2023/10/30 EUGIA PHARMA
211269 003 ANDA MITOMYCIN MITOMYCIN INJECTABLE;INJECTION 40MG/VIAL Prescription No No AP 2024/04/05 FRESENIUS KABI USA
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