药品注册申请号:018299
申请类型:NDA (新药申请)
申请人:MONARCH PHARMS
申请人全名:MONARCH PHARMACEUTICALS 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 VIROPTIC TRIFLURIDINE SOLUTION/DROPS;OPHTHALMIC 1% Yes Yes AT 1980/04/10 Approved Prior to Jan 1, 1982 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
2018/03/19 SUPPL 16 Approval Manufacturing (CMC) N/A
2002/02/20 SUPPL 14 Approval Labeling STANDARD
1997/10/17 SUPPL 9 Approval Labeling STANDARD
1997/03/06 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1997/02/10 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1996/12/31 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1996/12/10 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1995/05/08 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1991/12/30 SUPPL 6 Approval Labeling
1988/12/05 SUPPL 5 Approval Labeling
1983/03/14 SUPPL 4 Approval Manufacturing (CMC) PRIORITY
1981/08/20 SUPPL 3 Approval Manufacturing (CMC) PRIORITY
1980/12/30 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1980/06/27 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1980/04/10 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:TRIFLURIDINE 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:1% 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
018299 001 NDA VIROPTIC TRIFLURIDINE SOLUTION/DROPS;OPHTHALMIC 1% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 MONARCH PHARMS
074311 001 ANDA TRIFLURIDINE TRIFLURIDINE SOLUTION/DROPS;OPHTHALMIC 1% Prescription No No AT 1995/10/06 SANDOZ INC
205438 001 ANDA TRIFLURIDINE TRIFLURIDINE SOLUTION/DROPS;OPHTHALMIC 1% Prescription No No AT 2017/07/28 HI TECH
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