药品注册申请号:019270
申请类型:NDA (新药申请)
申请人:SANDOZ
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
2016/08/05 SUPPL-38(补充) Approval Manufacturing (CMC) PRIORITY
2016/05/05 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
2016/05/05 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
2015/05/11 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
2014/09/25 SUPPL-34(补充) Approval Manufacturing (CMC) PRIORITY
2006/02/14 SUPPL-31(补充) Approval Labeling STANDARD
2002/12/04 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
2002/03/13 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
2001/03/16 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
2000/02/18 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1999/08/17 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1999/04/07 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1999/03/26 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1999/03/11 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1999/02/05 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1998/08/04 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1998/01/15 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1995/11/01 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1995/11/01 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1993/01/22 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1991/10/28 SUPPL-11(补充) Approval Labeling
1991/04/10 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1991/02/14 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1990/07/09 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1989/07/19 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1988/08/31 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1988/07/13 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1987/09/24 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1986/11/04 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1986/07/07 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1986/05/27 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1985/12/12 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1985/12/12 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1985/08/30 ORIG-1(原始申请) 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
075386 001 ANDA BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT 2000/06/30 SCIEGEN PHARMS INC
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 ACELLA
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