药品注册申请号:019845
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
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 BETOPTIC S BETAXOLOL HYDROCHLORIDE SUSPENSION/DROPS;OPHTHALMIC EQ 0.25% BASE Yes Yes None 1989/12/29 1989/12/29 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
2017/02/01 SUPPL 25 Approval Labeling STANDARD
2016/06/16 SUPPL 27 Approval Manufacturing (CMC) STANDARD
2016/03/24 SUPPL 26 Approval Manufacturing (CMC) STANDARD
2008/05/08 SUPPL 21 Approval Labeling STANDARD
2007/06/08 SUPPL 20 Approval Efficacy PRIORITY
2003/05/09 SUPPL 17 Approval Labeling STANDARD
2002/12/04 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2001/03/16 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2000/02/18 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1999/08/17 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1999/04/07 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1999/04/05 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1999/03/11 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1999/02/23 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1999/02/05 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1998/10/14 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1998/08/27 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1995/11/01 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1995/11/01 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1993/01/22 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1991/04/10 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1990/12/20 SUPPL 1 Approval Labeling
1989/12/29 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 4911920 2007/03/27 Y U-224 PDF格式**本条是由Drugfuture回溯的历史信息**
4911920*PED 2007/09/27 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
001 M-14 2010/06/08**本条是由Drugfuture回溯的历史信息**
PED 2010/12/08**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
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