药品注册申请号:214401
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA INC
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 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML No No AP 2023/04/05 2023/04/05 Prescription
002 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML No No AP 2023/04/05 Prescription
003 CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML No No AP 2023/04/05 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
2023/04/05 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:CLINDAMYCIN PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 6MG BASE/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
201692 001 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML Prescription No Yes AP 2012/05/31 SANDOZ INC
203048 001 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML Prescription No No AP 2013/04/04 RISING
208084 001 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML Prescription No No AP 2017/06/28 BAXTER HLTHCARE CORP
214401 001 ANDA CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 6MG BASE/ML Prescription No No AP 2023/04/05 HIKMA
活性成分:CLINDAMYCIN PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 12MG BASE/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
201692 002 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML Prescription No Yes AP 2012/05/31 SANDOZ INC
203048 002 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML Prescription No No AP 2013/04/04 RISING
208084 002 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML Prescription No No AP 2017/06/28 BAXTER HLTHCARE CORP
214401 002 ANDA CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 12MG BASE/ML Prescription No No AP 2023/04/05 HIKMA
活性成分:CLINDAMYCIN PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 18MG BASE/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
201692 003 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML Prescription No Yes AP 2012/05/31 SANDOZ INC
203048 003 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML Prescription No No AP 2013/04/04 RISING
208084 003 ANDA CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML Prescription No No AP 2017/06/28 BAXTER HLTHCARE CORP
214401 003 ANDA CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 18MG BASE/ML Prescription No No AP 2023/04/05 HIKMA
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