药品注册申请号:019270
申请类型:NDA (新药申请)
申请人:SANDOZ INC
申请人全名:SANDOZ INC
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 BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Yes Yes AT 1985/08/30 1985/08/30 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
2016/08/05 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
2016/05/05 SUPPL 37 Approval Manufacturing (CMC) PRIORITY
2016/05/05 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
2015/05/11 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
2014/09/25 SUPPL 34 Approval Manufacturing (CMC) PRIORITY
2006/02/14 SUPPL 31 Approval Labeling STANDARD
2002/12/04 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
2002/03/13 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
2001/03/16 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
2000/02/18 SUPPL 26 Approval Manufacturing (CMC) PRIORITY
1999/08/17 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1999/04/07 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1999/03/26 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1999/03/11 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1999/02/05 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1998/08/04 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1998/01/15 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
1995/11/01 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
1995/11/01 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1993/01/22 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1991/10/28 SUPPL 11 Approval Labeling
1991/04/10 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1991/02/14 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1990/07/09 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1989/07/19 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1988/08/31 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1988/07/13 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1987/09/24 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1986/11/04 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1986/07/07 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1986/05/27 SUPPL 4 Approval Manufacturing (CMC) PRIORITY
1985/12/12 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1985/12/12 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1985/08/30 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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:BETAXOLOL HYDROCHLORIDE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:EQ 0.5% BASE 治疗等效代码:AT
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
019270 001 NDA BETOPTIC BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription Yes Yes AT 1985/08/30 SANDOZ INC
075386 001 ANDA BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT 2000/06/30 AKORN
075630 001 ANDA BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT 2001/04/12 MEDIMETRIKS PHARMS
078694 001 ANDA BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT 2009/11/16 WOCKHARDT
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