药品注册申请号:018469
申请类型:NDA (新药申请)
申请人:ALCON
申请人全名:ALCON LABORATORIES 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 BSS PLUS CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE SOLUTION;IRRIGATION 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML Yes Yes None 1981/10/28 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
2016/04/27 SUPPL 56 Approval Labeling STANDARD
2015/11/06 SUPPL 55 Approval Manufacturing (CMC) STANDARD
2015/11/06 SUPPL 54 Approval Labeling STANDARD
2015/02/09 SUPPL 53 Approval Manufacturing (CMC) STANDARD
2013/05/29 SUPPL 52 Approval Manufacturing (CMC) STANDARD
2004/12/20 SUPPL 41 Approval Labeling STANDARD
2004/12/20 SUPPL 40 Approval Manufacturing (CMC) STANDARD
2004/05/25 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2004/05/25 SUPPL 38 Approval Labeling STANDARD
2003/07/16 SUPPL 37 Approval Labeling STANDARD
2003/07/16 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1999/10/18 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1998/12/29 SUPPL 32 Approval Labeling STANDARD
1998/03/20 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1997/11/03 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1997/05/02 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1997/01/14 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1994/08/19 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1994/07/13 SUPPL 29 Approval Labeling STANDARD
1993/06/15 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1993/06/08 SUPPL 27 Approval Labeling STANDARD
1993/03/24 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1992/03/23 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1991/12/30 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1990/06/29 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1990/06/29 SUPPL 21 Approval Labeling
1989/10/24 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1988/11/30 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1988/11/17 SUPPL 14 Approval Labeling
1988/11/08 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1988/09/30 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1988/06/08 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1987/09/10 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1987/03/27 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1986/09/29 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1986/02/13 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1986/01/24 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1985/10/22 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1985/06/17 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1983/11/14 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1982/06/08 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1982/06/08 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1982/02/25 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1981/10/28 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
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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