药品注册申请号:008370
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN SALES LLC
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 Yes AP 1952/08/13 1984/10/15 Prescription
002 BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Yes Yes AP 1984/10/15 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2013/01/11 SUPPL 33 Approval Labeling STANDARD
2011/08/01 SUPPL 32 Approval Labeling UNKNOWN
2007/02/02 SUPPL 31 Approval Labeling STANDARD
2002/08/12 SUPPL 30 Approval Labeling STANDARD
2000/06/23 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1999/08/17 SUPPL 28 Approval Labeling STANDARD
1996/09/06 SUPPL 27 Approval Labeling STANDARD
1993/01/04 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1991/12/23 SUPPL 26 Approval Labeling
1991/03/18 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1990/09/25 SUPPL 24 Approval Labeling
1989/08/04 SUPPL 13 Approval Labeling
1988/02/18 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1987/02/06 SUPPL 21 Approval Labeling
1985/06/12 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1985/05/13 SUPPL 19 Approval Labeling
1984/10/15 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1984/10/15 SUPPL 17 Approval Labeling
1952/08/13 ORIG 1 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
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 ALLERGAN
008370 002 NDA BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AP 1984/10/15 ALLERGAN
040465 001 ANDA DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2003/06/30 WEST-WARD PHARMS INT
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 Prescription No No AP 2018/05/04 AKORN INC
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
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 PHARMS
210788 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/02/11 CUSTOPHARM INC
212058 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/04/26 SUNGEN PHARMA
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 ALLERGAN
008370 002 NDA BENTYL PRESERVATIVE FREE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AP 1984/10/15 ALLERGAN
040465 001 ANDA DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2003/06/30 WEST-WARD PHARMS INT
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 Prescription No No AP 2018/05/04 AKORN INC
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
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 PHARMS
210788 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/02/11 CUSTOPHARM INC
212058 001 ANDA DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2019/04/26 SUNGEN PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database