药品注册申请号:040319
申请类型:ANDA (仿制药申请)
申请人:AUROBINDO PHARMA USA
申请人全名:AUROBINDO PHARMA 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 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG No No AB 1999/09/07 1999/09/07 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
2013/04/30 SUPPL-8(补充) Approval Labeling STANDARD
2012/12/28 SUPPL-7(补充) Approval Labeling STANDARD
2007/11/30 SUPPL-3(补充) Approval Labeling
2002/12/12 SUPPL-2(补充) Approval Manufacturing (CMC)
1999/12/22 SUPPL-1(补充) Approval Labeling
1999/09/07 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
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:DICYCLOMINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;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
084285 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No Yes AB Approved Prior to Jan 1, 1982 LANNETT
085082 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 1986/06/19 WATSON LABS
040204 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 1997/02/28 WEST WARD
040319 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 1999/09/07 AUROBINDO PHARMA USA
217054 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2022/12/27 TWI PHARMS
216639 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/03/24 COREPHARMA
217531 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG Prescription No No AB 2023/08/30 PRINSTON INC
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药品NDC数据与药品包装、标签说明书
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