药品注册申请号：065217
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS USA
申请人全名：ZYDUS 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 HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE No No AB 2005/01/31 2005/01/31 Prescription
002 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE No No AB 2005/01/31 Prescription
003 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE No No AB 2005/01/31 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
2019/08/19 SUPPL-6（补充） Approval Labeling STANDARD
2019/08/19 SUPPL-5（补充） Approval Labeling STANDARD
2019/08/19 SUPPL-4（补充） Approval Labeling STANDARD
2019/08/19 SUPPL-3（补充） Approval Labeling STANDARD
2011/12/27 SUPPL-2（补充） Approval Labeling
2005/01/31 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 HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG BASE 治疗等效代码:AB
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
065242 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB -- LANNETT
050162 001 NDA CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
065217 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2005/01/31 ZYDUS PHARMS USA
065243 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2005/08/12 CHARTWELL MOLECULAR
207402 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2018/11/05 MICRO LABS
216957 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2023/03/10 GLENMARK PHARMS LTD
活性成分:CLINDAMYCIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 150MG BASE 治疗等效代码:AB
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
065242 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB -- LANNETT
050162 002 NDA CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
063029 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Discontinued No No AB 1989/09/20 COSETTE
063083 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Discontinued No No AB 1991/07/31 WATSON LABS
065061 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2001/02/02 SUN PHARM INDS LTD
065194 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2004/03/22 EPIC PHARMA LLC
065217 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2005/01/31 ZYDUS PHARMS USA
065442 001 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2009/08/26 AUROBINDO PHARMA
207402 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2018/11/05 MICRO LABS
216957 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE Prescription No No AB 2023/03/10 GLENMARK PHARMS LTD
活性成分:CLINDAMYCIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 300MG BASE 治疗等效代码:AB
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
050162 003 NDA CLEOCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription Yes Yes AB 1988/04/14 PFIZER
065061 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription No No AB 2001/02/02 SUN PHARM INDS LTD
063083 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Discontinued No No AB 2003/03/18 WATSON LABS
065194 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription No No AB 2004/03/22 EPIC PHARMA LLC
065217 003 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription No No AB 2005/01/31 ZYDUS PHARMS USA
063029 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Discontinued No No AB 2005/08/05 COSETTE
065442 002 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription No No AB 2009/08/26 AUROBINDO PHARMA
207402 003 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription No No AB 2018/11/05 MICRO LABS
216957 003 ANDA CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE;ORAL EQ 300MG BASE Prescription No No AB 2023/03/10 GLENMARK PHARMS LTD
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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