药品注册申请号:080248
申请类型:ANDA (仿制药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN 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 ALBALON NAPHAZOLINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No None 1972/03/24 Approved Prior to Jan 1, 1982 Discontinued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 42 Approval Manufacturing (CMC)
2002/07/03 SUPPL 40 Approval Manufacturing (CMC)
2001/11/15 SUPPL 39 Approval Manufacturing (CMC)
2001/08/15 SUPPL 38 Approval Manufacturing (CMC)
2000/12/08 SUPPL 37 Approval Manufacturing (CMC)
1999/03/18 SUPPL 35 Approval Manufacturing (CMC)
1998/08/24 SUPPL 36 Approval Manufacturing (CMC)
1997/09/29 SUPPL 34 Approval Manufacturing (CMC)
1997/09/29 SUPPL 33 Approval Manufacturing (CMC)
1995/06/21 SUPPL 32 Approval Manufacturing (CMC)
1995/06/21 SUPPL 31 Approval Manufacturing (CMC)
1994/09/27 SUPPL 30 Approval Manufacturing (CMC)
1992/05/07 SUPPL 29 Approval Manufacturing (CMC)
1991/03/25 SUPPL 28 Approval Labeling
1988/01/20 SUPPL 26 Approval Manufacturing (CMC)
1987/06/05 SUPPL 25 Approval Manufacturing (CMC)
1983/05/12 SUPPL 20 Approval Manufacturing (CMC)
1972/03/24 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
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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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