药品注册申请号:080660
申请类型:ANDA (仿制药申请)
申请人:MIZA PHARMS USA
申请人全名:MIZA PHARMACEUTICALS USA 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 OCUSULF-10 SULFACETAMIDE SODIUM SOLUTION/DROPS;OPHTHALMIC 10% No No None 1972/08/24 Approved Prior to Jan 1, 1982 Discontinued
002 OCUSULF-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
1996/03/07 SUPPL 46 Approval Manufacturing (CMC)
1996/03/07 SUPPL 45 Approval Labeling
1996/02/13 SUPPL 47 Approval Manufacturing (CMC)
1993/05/06 SUPPL 44 Approval Labeling
1992/07/07 SUPPL 43 Approval Labeling
1992/07/07 SUPPL 42 Approval Manufacturing (CMC)
1990/04/04 SUPPL 41 Approval Labeling
1985/08/20 SUPPL 37 Approval Manufacturing (CMC)
1985/06/19 SUPPL 39 Approval Manufacturing (CMC)
1985/06/19 SUPPL 34 Approval Manufacturing (CMC)
1985/06/19 SUPPL 30 Approval Manufacturing (CMC)
1984/12/13 SUPPL 35 Approval Manufacturing (CMC)
1984/02/07 SUPPL 32 Approval Manufacturing (CMC)
1982/07/15 SUPPL 29 Approval Manufacturing (CMC)
1972/08/24 ORIG 1 Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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