药品注册申请号：008370
申请类型：NDA (新药申请)
申请人：ABBVIE
申请人全名：ABBVIE 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 BENTYL DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Yes No AP 1952/08/13 1984/10/15 Discontinued
002 BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Yes No AP 1984/10/15 Discontinued
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
2013/01/11 SUPPL-33（补充） Approval Labeling STANDARD
2011/08/01 SUPPL-32（补充） Approval Labeling UNKNOWN
2007/02/02 SUPPL-31（补充） Approval Labeling STANDARD
2002/08/12 SUPPL-30（补充） Approval Labeling STANDARD
2000/06/23 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1999/08/17 SUPPL-28（补充） Approval Labeling STANDARD
1996/09/06 SUPPL-27（补充） Approval Labeling STANDARD
1993/01/04 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1991/12/23 SUPPL-26（补充） Approval Labeling
1991/03/18 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1990/09/25 SUPPL-24（补充） Approval Labeling
1989/08/04 SUPPL-13（补充） Approval Labeling
1988/02/18 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1987/02/06 SUPPL-21（补充） Approval Labeling
1985/06/12 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1985/05/13 SUPPL-19（补充） Approval Labeling
1984/10/15 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1984/10/15 SUPPL-17（补充） Approval Labeling
1952/08/13 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
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: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 Discontinued Yes No AP 1984/10/15 ABBVIE
008370 002 NDA BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Discontinued Yes No AP 1984/10/15 ABBVIE
040465 001 ANDA DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No Yes 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 Yes 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
214332 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2024/11/01 SOMERSET THERAPS LLC
214333 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2024/11/01 SOMERSET THERAPS LLC
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 Discontinued Yes No AP 1984/10/15 ABBVIE
008370 002 NDA BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Discontinued Yes No AP 1984/10/15 ABBVIE
040465 001 ANDA DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No Yes 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 Yes 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
214332 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2024/11/01 SOMERSET THERAPS LLC
214333 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2024/11/01 SOMERSET THERAPS LLC
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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