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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/04/13 SUPPL-60(补充) Approval Labeling STANDARD
2016/04/27 SUPPL-56(补充) Approval Labeling STANDARD
2015/11/06 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
2015/11/06 SUPPL-54(补充) Approval Labeling STANDARD
2015/02/09 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
2013/05/29 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
2004/12/20 SUPPL-41(补充) Approval Labeling STANDARD
2004/12/20 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
2004/05/25 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
2004/05/25 SUPPL-38(补充) Approval Labeling STANDARD
2003/07/16 SUPPL-37(补充) Approval Labeling STANDARD
2003/07/16 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1999/10/18 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1998/12/29 SUPPL-32(补充) Approval Labeling STANDARD
1998/03/20 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1997/11/03 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1997/05/02 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1997/01/14 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1994/08/19 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1994/07/13 SUPPL-29(补充) Approval Labeling STANDARD
1993/06/15 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1993/06/08 SUPPL-27(补充) Approval Labeling STANDARD
1993/03/24 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1992/03/23 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1991/12/30 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1990/06/29 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1990/06/29 SUPPL-21(补充) Approval Labeling
1989/10/24 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1988/11/30 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1988/11/17 SUPPL-14(补充) Approval Labeling
1988/11/08 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1988/09/30 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1988/06/08 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1987/09/10 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1987/03/27 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1986/09/29 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1986/02/13 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1986/01/24 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1985/10/22 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1985/06/17 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1983/11/14 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1982/06/08 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1982/06/08 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1982/02/25 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1981/10/28 ORIG-1(原始申请) 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
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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