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 Yes 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002 DIASTAT DIAZEPAM GEL;RECTAL 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/07/29 Discontinued
003 DIASTAT DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/07/29 Discontinued
004 DIASTAT DIAZEPAM GEL;RECTAL 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/07/29 Discontinued
005 DIASTAT DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/07/29 Discontinued
006 DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) Yes Yes AB 2005/09/15 Prescription
007 DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) Yes Yes AB 2005/09/15 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
2023/01/13 SUPPL-23(补充) Approval Labeling STANDARD
2021/03/25 SUPPL-22(补充) Approval Labeling STANDARD
2021/02/05 SUPPL-21(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-14(补充) Approval Labeling STANDARD
2016/10/27 SUPPL-13(补充) Approval Labeling STANDARD
2014/12/16 SUPPL-12(补充) Approval Labeling STANDARD
2013/08/29 SUPPL-9(补充) Approval Labeling STANDARD
2005/09/15 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2002/06/18 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
2001/04/11 SUPPL-2(补充) Approval Labeling STANDARD
2000/10/17 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
2000/08/31 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1998/08/25 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD ;Orphan
1997/07/29 ORIG-1(原始申请) Approval Type 3 - New Dosage Form STANDARD ;Orphan
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
活性成分:DIAZEPAM 剂型/给药途径:GEL;RECTAL 规格:20MG/4ML (5MG/ML) 治疗等效代码:AB
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
020648 006 NDA DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) Prescription Yes Yes AB 2005/09/15 BAUSCH
091076 002 ANDA DIAZEPAM DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) Prescription No No AB 2023/05/30 NOVEL LABS INC
活性成分:DIAZEPAM 剂型/给药途径:GEL;RECTAL 规格:10MG/2ML (5MG/ML) 治疗等效代码:AB
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
020648 007 NDA DIASTAT ACUDIAL DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) Prescription Yes Yes AB 2005/09/15 BAUSCH
091076 001 ANDA DIAZEPAM DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) Prescription No No AB 2023/05/30 NOVEL LABS INC
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