药品注册申请号:050356
申请类型:NDA (新药申请)
申请人:ENDO OPERATIONS
申请人全名:ENDO OPERATIONS LTD
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 COLY-MYCIN S COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE SUSPENSION/DROPS;OTIC EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML Yes Yes None 1962/05/17 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
2019/01/05 SUPPL-59(补充) Approval Labeling STANDARD
2016/03/29 SUPPL-56(补充) Approval Manufacturing (CMC)
2013/12/06 SUPPL-55(补充) Approval Manufacturing (CMC)
2009/06/02 SUPPL-50(补充) Approval Labeling STANDARD
2002/03/01 SUPPL-45(补充) Approval Labeling STANDARD
2001/12/05 SUPPL-48(补充) Approval Manufacturing (CMC)
2001/09/27 SUPPL-47(补充) Approval Manufacturing (CMC)
1997/04/23 SUPPL-46(补充) Approval Manufacturing (CMC)
1997/01/08 SUPPL-43(补充) Approval Labeling STANDARD
1994/08/02 SUPPL-44(补充) Approval Manufacturing (CMC)
1991/07/01 SUPPL-6(补充) Approval Manufacturing (CMC)
1986/03/17 SUPPL-5(补充) Approval Manufacturing (CMC)
1985/12/17 SUPPL-4(补充) Approval Manufacturing (CMC)
1984/03/23 SUPPL-3(补充) Approval Manufacturing (CMC)
1983/09/13 SUPPL-2(补充) Approval Manufacturing (CMC)
1982/12/28 SUPPL-1(补充) Approval Manufacturing (CMC)
1982/08/03 SUPPL-42(补充) Approval Manufacturing (CMC)
1982/03/18 SUPPL-40(补充) Approval Manufacturing (CMC)
1982/03/05 SUPPL-41(补充) Approval Manufacturing (CMC)
1981/10/19 SUPPL-39(补充) Approval Manufacturing (CMC)
1980/10/15 SUPPL-38(补充) Approval Labeling
1979/10/17 SUPPL-37(补充) Approval Labeling
1978/07/19 SUPPL-36(补充) Approval Manufacturing (CMC)
1976/11/18 SUPPL-35(补充) Approval Manufacturing (CMC)
1972/10/16 SUPPL-34(补充) Approval Labeling
1968/11/20 SUPPL-32(补充) Approval Manufacturing (CMC)
1967/11/24 SUPPL-31(补充) Approval Manufacturing (CMC)
1967/07/17 SUPPL-30(补充) Approval Manufacturing (CMC)
1967/07/14 SUPPL-29(补充) Approval Labeling
1967/04/18 SUPPL-28(补充) Approval Labeling
1967/03/08 SUPPL-27(补充) Approval Labeling
1967/01/31 SUPPL-26(补充) Approval Labeling
1967/01/31 SUPPL-25(补充) Approval Labeling
1966/12/30 SUPPL-22(补充) Approval Manufacturing (CMC)
1966/12/21 SUPPL-24(补充) Approval Labeling
1966/10/31 SUPPL-23(补充) Approval Manufacturing (CMC)
1966/05/20 SUPPL-21(补充) Approval Manufacturing (CMC)
1966/04/22 SUPPL-20(补充) Approval Labeling
1966/01/07 SUPPL-18(补充) Approval Manufacturing (CMC)
1965/12/14 SUPPL-16(补充) Approval Manufacturing (CMC)
1965/11/15 SUPPL-17(补充) Approval Labeling
1965/07/27 SUPPL-15(补充) Approval Labeling
1965/05/26 SUPPL-12(补充) Approval Manufacturing (CMC)
1965/04/16 SUPPL-14(补充) Approval Labeling
1964/08/20 SUPPL-10(补充) Approval Manufacturing (CMC)
1964/05/14 SUPPL-9(补充) Approval Manufacturing (CMC)
1964/04/16 SUPPL-8(补充) Approval Manufacturing (CMC)
1964/04/16 SUPPL-7(补充) Approval Manufacturing (CMC)
1962/05/17 ORIG-1(原始申请) Approval UNKNOWN
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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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