药品注册申请号:018925
申请类型:NDA (新药申请)
申请人:EXELA PHARMA
申请人全名:EXELA PHARMA SCIENCES 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 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) No No AP 1984/03/30 1984/03/30 Prescription
002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/4ML (2.5MG/ML) No No None 2018/04/05 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
2016/11/18 SUPPL-10(补充) Approval Labeling STANDARD
2016/04/08 SUPPL-9(补充) Approval Manufacturing (CMC) N/A
2011/11/02 SUPPL-8(补充) Approval Labeling UNKNOWN
2010/04/13 SUPPL-7(补充) Approval Labeling UNKNOWN
1988/10/25 SUPPL-6(补充) Approval Labeling
1986/09/16 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1986/09/15 SUPPL-5(补充) Approval Labeling
1986/09/15 SUPPL-3(补充) Approval Labeling
1985/02/21 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1984/07/10 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1984/03/30 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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:VERAPAMIL HYDROCHLORIDE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:5MG/2ML (2.5MG/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
018925 001 NDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 1984/03/30 EXELA PHARMA
070737 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No Yes AP 1987/05/06 HOSPIRA
070738 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No Yes AP 1987/05/06 HOSPIRA
075136 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No Yes AP 1998/10/20 HOSPIRA
211015 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 2018/06/18 SOMERSET THERAPS LLC
211035 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 2018/06/18 SOMERSET
210994 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 2018/07/13 AMNEAL
211370 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 2018/12/28 MICRO LABS
213232 001 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 2020/03/25 CAPLIN
213352 002 ANDA VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE SOLUTION;INTRAVENOUS 5MG/2ML (2.5MG/ML) Prescription No No AP 2020/09/16 NEPHRON
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