药品注册申请号:050218
申请类型:NDA (新药申请)
申请人:MONARCH PHARMS
申请人全名:MONARCH PHARMACEUTICALS LLC
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 CORTISPORIN HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE CREAM;TOPICAL 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM Yes No None 1963/04/16 1985/08/09 Discontinued
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
2013/03/26 SUPPL-62(补充) Approval Manufacturing (CMC)
2002/12/20 SUPPL-51(补充) Approval Labeling STANDARD
2001/03/21 SUPPL-50(补充) Approval Manufacturing (CMC)
2000/07/13 SUPPL-49(补充) Approval Manufacturing (CMC)
1999/07/19 SUPPL-47(补充) Approval Labeling STANDARD
1998/11/20 SUPPL-48(补充) Approval Manufacturing (CMC)
1992/04/23 SUPPL-7(补充) Approval Manufacturing (CMC)
1987/08/18 SUPPL-6(补充) Approval Manufacturing (CMC)
1985/12/04 SUPPL-5(补充) Approval Manufacturing (CMC)
1985/08/09 SUPPL-4(补充) Approval Labeling
1985/08/09 SUPPL-3(补充) Approval Labeling
1982/04/27 SUPPL-45(补充) Approval Manufacturing (CMC)
1982/03/26 SUPPL-44(补充) Approval Manufacturing (CMC)
1981/08/06 SUPPL-43(补充) Approval Manufacturing (CMC)
1977/01/13 SUPPL-42(补充) Approval Labeling
1974/05/01 SUPPL-41(补充) Approval Labeling
1974/04/24 SUPPL-40(补充) Approval Labeling
1974/03/08 SUPPL-39(补充) Approval Labeling
1972/10/04 SUPPL-38(补充) Approval Labeling
1972/07/27 SUPPL-37(补充) Approval Labeling
1972/07/25 SUPPL-36(补充) Approval Labeling
1972/06/21 SUPPL-35(补充) Approval Labeling
1972/03/22 SUPPL-34(补充) Approval Labeling
1971/05/11 SUPPL-33(补充) Approval Manufacturing (CMC)
1970/08/26 SUPPL-32(补充) Approval Labeling
1970/08/11 SUPPL-30(补充) Approval Manufacturing (CMC)
1970/07/27 SUPPL-31(补充) Approval Labeling
1970/05/12 SUPPL-29(补充) Approval Manufacturing (CMC)
1969/07/07 SUPPL-28(补充) Approval Labeling
1969/04/25 SUPPL-27(补充) Approval Labeling
1969/03/04 SUPPL-26(补充) Approval Manufacturing (CMC)
1968/01/29 SUPPL-25(补充) Approval Labeling
1967/06/19 SUPPL-24(补充) Approval Labeling
1967/05/15 SUPPL-23(补充) Approval Labeling
1967/03/29 SUPPL-22(补充) Approval Manufacturing (CMC)
1967/03/20 SUPPL-21(补充) Approval Labeling
1966/11/30 SUPPL-18(补充) Approval Manufacturing (CMC)
1966/07/22 SUPPL-20(补充) Approval Labeling
1965/01/28 SUPPL-17(补充) Approval Manufacturing (CMC)
1965/01/12 SUPPL-16(补充) Approval Manufacturing (CMC)
1964/07/15 SUPPL-15(补充) Approval Labeling
1964/05/08 SUPPL-14(补充) Approval Labeling
1964/05/08 SUPPL-13(补充) Approval Manufacturing (CMC)
1964/03/03 SUPPL-12(补充) Approval Labeling
1963/09/04 SUPPL-11(补充) Approval Labeling
1963/07/24 SUPPL-10(补充) Approval Labeling
1963/07/24 SUPPL-8(补充) Approval Labeling
1963/07/17 SUPPL-9(补充) Approval Labeling
1963/04/16 ORIG-1(原始申请) Approval UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
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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