药品注册申请号:080028
申请类型:ANDA (仿制药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN
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 BLEPH-10 SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 10% No Yes AT 1971/05/25 Approved Prior to Jan 1, 1982 Prescription
002 BLEPH-30 SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 30% No No None Approved Prior to Jan 1, 1982 Discontinued
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
2002/11/15 SUPPL 49 Approval Manufacturing (CMC)
2002/07/03 SUPPL 48 Approval Manufacturing (CMC)
2001/08/15 SUPPL 47 Approval Manufacturing (CMC)
2001/08/07 SUPPL 45 Approval Manufacturing (CMC)
2001/02/13 SUPPL 44 Approval Manufacturing (CMC)
2000/12/08 SUPPL 43 Approval Manufacturing (CMC)
1998/09/15 SUPPL 42 Approval Manufacturing (CMC)
1997/11/14 SUPPL 41 Approval Manufacturing (CMC)
1997/11/14 SUPPL 40 Approval Manufacturing (CMC)
1994/09/27 SUPPL 38 Approval Manufacturing (CMC)
1994/06/14 SUPPL 39 Approval Labeling
1993/06/29 SUPPL 37 Approval Manufacturing (CMC)
1993/01/27 SUPPL 36 Approval Labeling
1991/12/12 SUPPL 35 Approval Labeling
1991/12/12 SUPPL 32 Approval Manufacturing (CMC)
1991/12/12 SUPPL 31 Approval Manufacturing (CMC)
1991/12/12 SUPPL 30 Approval Manufacturing (CMC)
1991/12/12 SUPPL 29 Approval Manufacturing (CMC)
1991/12/12 SUPPL 28 Approval Manufacturing (CMC)
1991/03/27 SUPPL 26 Approval Labeling
1989/05/02 SUPPL 33 Approval Manufacturing (CMC)
1988/03/29 SUPPL 27 Approval Manufacturing (CMC)
1986/10/24 SUPPL 23 Approval Manufacturing (CMC)
1986/10/24 SUPPL 22 Approval Manufacturing (CMC)
1983/12/05 SUPPL 20 Approval Manufacturing (CMC)
1982/09/28 SUPPL 13 Approval Manufacturing (CMC)
1982/09/28 SUPPL 12 Approval Manufacturing (CMC)
1982/08/16 SUPPL 18 Approval Manufacturing (CMC)
1982/07/22 SUPPL 15 Approval Manufacturing (CMC)
1971/05/25 ORIG 1 Approval
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:SULFACETAMIDE SODIUM 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:10% 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
080028 001 ANDA BLEPH-10 SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 10% Prescription No Yes AT Approved Prior to Jan 1, 1982 ALLERGAN
089560 001 ANDA SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 10% Prescription No No AT 1988/10/18 SANDOZ INC
040066 001 ANDA SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 10% Prescription No No AT 1994/12/28 BAUSCH AND LOMB
040215 001 ANDA SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 10% Prescription No No AT 1999/05/25 AKORN
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