药品注册申请号:020648
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US 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 DIASTAT DIAZEPAM GEL;RECTAL 2.5MG/0.5ML (5MG/ML) Yes No None 1997/07/29 1997/07/29 Prescription
002 DIASTAT DIAZEPAM GEL;RECTAL 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/07/29 Discontinued
003 DIASTAT DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/07/29 Discontinued
004 DIASTAT DIAZEPAM GEL;RECTAL 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/07/29 Discontinued
005 DIASTAT DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/07/29 Discontinued
006 DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) Yes Yes None 2005/09/15 Prescription
007 DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) Yes No None 2005/09/15 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
2016/12/16 SUPPL 14 Approval Labeling STANDARD
2016/10/27 SUPPL 13 Approval Labeling STANDARD
2014/12/16 SUPPL 12 Approval Labeling STANDARD
2013/08/29 SUPPL 9 Approval Labeling STANDARD
2005/09/15 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2002/06/18 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2001/04/11 SUPPL 2 Approval Labeling STANDARD
2000/10/17 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2000/08/31 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1998/08/25 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/07/29 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
001 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
005 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
006 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
007 5462740 2013/09/17 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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
本品无治疗等效药品
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