药品注册申请号:040465
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA 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 DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No AP 2003/06/30 2003/06/30 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
2018/05/29 SUPPL-8(补充) Approval Labeling STANDARD
2018/05/29 SUPPL-7(补充) Approval Labeling STANDARD
2012/05/10 SUPPL-5(补充) Approval Labeling
2007/10/05 SUPPL-2(补充) Approval Labeling
2003/06/30 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:INJECTABLE;INJECTION 规格:10MG/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
008370 001 NDA BENTYL DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AP 1984/10/15 ABBVIE
008370 002 NDA BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AP 1984/10/15 ABBVIE
040465 001 ANDA DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2003/06/30 HIKMA
208353 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2017/02/17 AM REGENT
207084 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Discontinued No No AP 2018/05/04 RENEW PHARMS
210979 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2018/07/02 FOSUN PHARMA
207076 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2018/11/02 SLATE RUN PHARMA
210257 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/01/25 FRESENIUS KABI USA
206468 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/02/01 NEXUS
210788 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Discontinued No No AP 2019/02/11 HIKMA
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