药品注册申请号：071611
申请类型：ANDA (仿制药申请)
申请人：ACTAVIS LABS FL INC
申请人全名：ACTAVIS LABORATORIES FL 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 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 1988/02/29 1989/05/03 Prescription
002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2006/02/03 Prescription
003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG No No AB 2006/02/03 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
2013/07/30 SUPPL-70（补充） Approval Labeling STANDARD
2013/04/11 SUPPL-69（补充） Approval Labeling STANDARD
2012/09/24 SUPPL-67（补充） Approval Manufacturing (CMC)
2006/02/03 SUPPL-40（补充） Approval Manufacturing (CMC)
2006/02/03 SUPPL-39（补充） Approval Labeling
2006/02/03 SUPPL-38（补充） Approval Manufacturing (CMC)
2001/04/25 SUPPL-34（补充） Approval Manufacturing (CMC)
2000/12/29 SUPPL-33（补充） Approval Manufacturing (CMC)
1998/12/23 SUPPL-30（补充） Approval Manufacturing (CMC)
1996/08/15 SUPPL-29（补充） Approval Manufacturing (CMC)
1996/08/15 SUPPL-28（补充） Approval Manufacturing (CMC)
1996/08/15 SUPPL-27（补充） Approval Manufacturing (CMC)
1996/08/15 SUPPL-26（补充） Approval Manufacturing (CMC)
1996/08/15 SUPPL-25（补充） Approval Manufacturing (CMC)
1996/08/15 SUPPL-24（补充） Approval Manufacturing (CMC)
1993/12/20 SUPPL-23（补充） Approval Manufacturing (CMC)
1993/06/29 SUPPL-22（补充） Approval Labeling
1993/03/12 SUPPL-18（补充） Approval Labeling
1993/03/12 SUPPL-17（补充） Approval Manufacturing (CMC)
1992/09/29 SUPPL-16（补充） Approval Manufacturing (CMC)
1992/09/29 SUPPL-15（补充） Approval Manufacturing (CMC)
1992/09/29 SUPPL-14（补充） Approval Manufacturing (CMC)
1991/05/31 SUPPL-11（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-13（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-8（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-7（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-5（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-4（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-3（补充） Approval Manufacturing (CMC)
1991/02/23 SUPPL-2（补充） Approval Manufacturing (CMC)
1991/01/28 SUPPL-12（补充） Approval Manufacturing (CMC)
1990/02/22 SUPPL-10（补充） Approval Manufacturing (CMC)
1989/04/20 SUPPL-1（补充） Approval Manufacturing (CMC)
1988/02/29 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:CYCLOBENZAPRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
071611 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1989/05/03 ACTAVIS LABS FL INC
073541 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1995/05/23 ANDA REPOSITORY
077209 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2005/10/04 OXFORD PHARMS
077563 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2006/04/19 JUBILANT CADISTA
077797 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2007/02/28 PRINSTON INC
078218 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/04/18 CHARTWELL RX
078722 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/05/12 SUN PHARM INDS LTD
078643 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/09/26 AUROBINDO PHARMA
090478 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2010/07/23 INVAGEN PHARMS
078048 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/02/28 KVK TECH
208170 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No Yes AB 2017/05/31 RUBICON
213324 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2020/07/05 UNICHEM
218936 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2024/09/12 GRAVITI PHARMS
活性成分:CYCLOBENZAPRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
077209 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2006/02/03 OXFORD PHARMS
071611 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2006/02/03 ACTAVIS LABS FL INC
073541 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2006/04/06 ANDA REPOSITORY
077563 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2006/04/19 JUBILANT CADISTA
077797 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2007/02/28 PRINSTON INC
078722 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2008/05/12 SUN PHARM INDS LTD
078643 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2008/09/26 AUROBINDO PHARMA
090478 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2010/07/23 INVAGEN PHARMS
078048 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/02/28 KVK TECH
078218 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/06/19 CHARTWELL RX
208170 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2017/05/31 RUBICON
213324 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2020/07/06 UNICHEM
218936 001 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2024/09/12 GRAVITI PHARMS
活性成分:CYCLOBENZAPRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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
071611 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2006/02/03 ACTAVIS LABS FL INC
078722 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2008/05/12 SUN PHARM INDS LTD
208170 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2017/05/31 RUBICON
077563 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2017/08/25 JUBILANT CADISTA
213324 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2020/07/06 UNICHEM
078218 003 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2020/11/03 CHARTWELL RX
218936 002 ANDA CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET;ORAL 7.5MG Prescription No No AB 2024/09/12 GRAVITI PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
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