药品注册申请号:018086
申请类型:NDA (新药申请)
申请人:BAUSCH AND LOMB INC
申请人全名:BAUSCH AND LOMB 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 TIMOPTIC TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Yes No AT1 1978/08/17 Approved Prior to Jan 1, 1982 Prescription
002 TIMOPTIC TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Yes No AT1 Approved Prior to Jan 1, 1982 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
2021/11/17 SUPPL-80(补充) Approval Labeling STANDARD
2016/08/09 SUPPL-76(补充) Approval Labeling STANDARD
2011/09/30 SUPPL-75(补充) Approval Labeling STANDARD
2006/04/26 SUPPL-72(补充) Approval Labeling STANDARD
2006/04/26 SUPPL-70(补充) Approval Labeling STANDARD
2003/12/22 SUPPL-60(补充) Approval Manufacturing (CMC) PRIORITY
2002/12/06 SUPPL-62(补充) Approval Manufacturing (CMC) PRIORITY
2002/04/29 SUPPL-58(补充) Approval Labeling STANDARD
2002/04/17 SUPPL-59(补充) Approval Manufacturing (CMC) PRIORITY
2001/12/05 SUPPL-57(补充) Approval Manufacturing (CMC) PRIORITY
2001/11/30 SUPPL-56(补充) Approval Labeling STANDARD
2001/04/12 SUPPL-54(补充) Approval Manufacturing (CMC) PRIORITY
2000/09/18 SUPPL-53(补充) Approval Labeling STANDARD
1998/04/22 SUPPL-49(补充) Approval Manufacturing (CMC) PRIORITY
1998/03/18 SUPPL-52(补充) Approval Labeling STANDARD
1997/08/05 SUPPL-51(补充) Approval Labeling STANDARD
1997/05/16 SUPPL-47(补充) Approval Labeling STANDARD
1996/12/02 SUPPL-50(补充) Approval Manufacturing (CMC) PRIORITY
1996/07/18 SUPPL-46(补充) Approval Manufacturing (CMC) PRIORITY
1996/04/16 SUPPL-48(补充) Approval Manufacturing (CMC) PRIORITY
1995/04/25 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
1995/02/24 SUPPL-44(补充) Approval Labeling STANDARD
1995/02/24 SUPPL-43(补充) Approval Labeling STANDARD
1993/12/09 SUPPL-42(补充) Approval Labeling STANDARD
1992/05/20 SUPPL-38(补充) Approval Labeling
1992/05/20 SUPPL-37(补充) Approval Labeling
1992/05/20 SUPPL-35(补充) Approval Labeling
1990/03/19 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1988/01/15 SUPPL-34(补充) Approval Manufacturing (CMC) PRIORITY
1987/08/04 SUPPL-33(补充) Approval Labeling
1987/08/04 SUPPL-32(补充) Approval Labeling
1987/08/04 SUPPL-28(补充) Approval Labeling
1987/08/04 SUPPL-14(补充) Approval Labeling
1987/06/05 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
1986/11/28 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1986/02/27 SUPPL-29(补充) Approval Labeling
1986/02/12 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1984/11/29 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
1984/06/14 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1983/09/07 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1982/06/30 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1981/11/03 SUPPL-18(补充) Approval Labeling
1981/10/27 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1981/10/09 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1981/10/09 SUPPL-15(补充) Approval Labeling
1981/07/15 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1981/03/31 SUPPL-13(补充) Approval Labeling
1980/06/20 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1980/05/21 SUPPL-10(补充) Approval Labeling
1980/05/13 SUPPL-7(补充) Approval Labeling
1980/02/11 SUPPL-9(补充) Approval Labeling
1980/01/08 SUPPL-1(补充) Approval Labeling
1980/01/02 SUPPL-2(补充) Approval Labeling
1979/12/03 SUPPL-5(补充) Approval Labeling
1979/07/20 SUPPL-6(补充) Approval Labeling
1979/04/06 SUPPL-4(补充) Approval Labeling
1978/08/17 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:TIMOLOL MALEATE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:EQ 0.25% BASE 治疗等效代码:AT1
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
018086 001 NDA TIMOPTIC TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription Yes No AT1 Approved Prior to Jan 1, 1982 BAUSCH AND LOMB INC
074261 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No Yes AT1 1995/04/28 SANDOZ
074746 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT1 1997/03/25 PACIFIC PHARMA
074778 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Discontinued No No AT1 1997/03/25 BAUSCH AND LOMB
077259 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT1 2008/04/30 FDC LTD
078771 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT1 2009/09/28 MANKIND PHARMA
217343 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT1 2023/05/26 MICRO LABS
217764 002 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.25% BASE Prescription No No AT1 2024/07/03 SOMERSET
活性成分:TIMOLOL MALEATE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:EQ 0.5% BASE 治疗等效代码:AT1
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
018086 002 NDA TIMOPTIC TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription Yes No AT1 Approved Prior to Jan 1, 1982 BAUSCH AND LOMB INC
074262 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No Yes AT1 1995/04/28 SANDOZ
074466 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT1 1997/03/25 SCIEGEN PHARMS INC
074516 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT1 1997/03/25 EPIC PHARMA LLC
074747 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 1997/03/25 PACIFIC PHARMA
074776 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT1 1997/03/25 BAUSCH AND LOMB
075163 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Discontinued No No AT1 2002/09/10 HIKMA
077259 002 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2008/04/30 FDC LTD
078771 002 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2009/09/28 MANKIND PHARMA
217343 002 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2023/05/26 MICRO LABS
217764 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2024/07/03 SOMERSET
218460 001 ANDA TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE Prescription No No AT1 2024/08/07 CAPLIN
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