药品注册申请号:084015
申请类型:ANDA (仿制药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN PHARMACEUTICAL
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 OINTMENT;OPHTHALMIC 10% No No None 1975/01/07 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
2001/08/15 SUPPL 19 Approval Manufacturing (CMC)
2001/06/08 SUPPL 20 Approval Manufacturing (CMC)
1999/11/15 SUPPL 18 Approval Manufacturing (CMC)
1998/06/24 SUPPL 17 Approval Manufacturing (CMC)
1998/03/27 SUPPL 16 Approval Manufacturing (CMC)
1998/03/27 SUPPL 15 Approval Manufacturing (CMC)
1998/03/27 SUPPL 14 Approval Manufacturing (CMC)
1998/03/27 SUPPL 13 Approval Manufacturing (CMC)
1996/12/12 SUPPL 12 Approval Labeling
1996/12/04 SUPPL 11 Approval Manufacturing (CMC)
1996/02/22 SUPPL 10 Approval Manufacturing (CMC)
1994/02/08 SUPPL 9 Approval Labeling
1993/06/29 SUPPL 8 Approval Manufacturing (CMC)
1992/07/14 SUPPL 6 Approval Manufacturing (CMC)
1991/04/16 SUPPL 5 Approval Manufacturing (CMC)
1991/04/16 SUPPL 4 Approval Manufacturing (CMC)
1988/07/22 SUPPL 3 Approval Labeling
1988/02/12 SUPPL 2 Approval Manufacturing (CMC)
1975/01/07 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
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与本品治疗等效的药品
本品无治疗等效药品
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