药品注册申请号：216736
申请类型：ANDA (仿制药申请)
申请人：RUBICON RESEARCH
申请人全名：RUBICON RESEARCH LTD
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 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG No No AB 2022/12/14 2022/12/14 Prescription
002 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 40MG No Yes None 2025/03/25 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2022/12/14 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/09/15 SUPPL-3（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert UNKNOWN
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:DICYCLOMINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 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
085223 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No Yes AB 1986/07/30 WATSON LABS
040161 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1996/10/01 HIKMA PHARMS
040230 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1999/02/26 LANNETT
040317 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1999/09/07 AUROBINDO PHARMA USA
216760 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2022/11/28 COREPHARMA
216736 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2022/12/14 RUBICON RESEARCH
216782 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2023/06/01 TWI PHARMS
217916 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2023/08/04 BIONPHARMA
217566 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2024/05/07 ANNORA PHARMA
218952 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2024/11/15 RISING
218310 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2025/06/06 PRINSTON 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
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