药品注册申请号：065347
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 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML No No AP 2007/05/09 2007/05/09 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
2007/05/09 ORIG-1（原始申请） Approval
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:CLINDAMYCIN PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 150MG 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
050441 001 NDA CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 PFIZER
062800 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 1987/07/24 ALMAJECT
062803 001 ANDA CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 1987/10/16 PFIZER
062889 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 1988/04/25 HIKMA
062943 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 1988/09/29 ALMAJECT
065206 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 2004/09/24 HIKMA
065346 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 2007/03/29 FRESENIUS KABI USA
065347 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 2007/05/09 FRESENIUS KABI USA
090108 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 2011/09/30 SAGENT PHARMS INC
090109 001 ANDA CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE INJECTABLE;INJECTION EQ 150MG BASE/ML Prescription No No AP 2011/09/30 SAGENT PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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