药品注册申请号:050168
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
002 CORTISPORIN BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE OINTMENT;TOPICAL 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Yes No None 1957/03/26 1984/05/04 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
2003/11/21 SUPPL-78(补充) Approval Labeling STANDARD
2001/08/13 SUPPL-76(补充) Approval Manufacturing (CMC)
1999/07/19 SUPPL-73(补充) Approval Labeling STANDARD
1999/05/28 SUPPL-75(补充) Approval Manufacturing (CMC)
1998/11/04 SUPPL-74(补充) Approval Manufacturing (CMC)
1993/09/22 SUPPL-9(补充) Approval Manufacturing (CMC)
1986/05/16 SUPPL-5(补充) Approval Labeling
1986/04/07 SUPPL-6(补充) Approval Manufacturing (CMC)
1985/12/04 SUPPL-4(补充) Approval Labeling
1984/06/25 SUPPL-2(补充) Approval Labeling
1983/07/06 SUPPL-1(补充) Approval Manufacturing (CMC)
1982/03/26 SUPPL-70(补充) Approval Manufacturing (CMC)
1981/10/20 SUPPL-69(补充) Approval Manufacturing (CMC)
1978/06/19 SUPPL-67(补充) Approval Manufacturing (CMC)
1977/05/06 SUPPL-66(补充) Approval Manufacturing (CMC)
1977/01/13 SUPPL-65(补充) Approval Labeling
1974/06/16 SUPPL-64(补充) Approval Manufacturing (CMC)
1974/04/24 SUPPL-63(补充) Approval Labeling
1974/02/12 SUPPL-62(补充) Approval Manufacturing (CMC)
1973/05/23 SUPPL-56(补充) Approval Labeling
1972/10/17 SUPPL-61(补充) Approval Manufacturing (CMC)
1972/10/16 SUPPL-60(补充) Approval Labeling
1972/07/05 SUPPL-59(补充) Approval Labeling
1972/06/23 SUPPL-58(补充) Approval Labeling
1971/05/10 SUPPL-57(补充) Approval Manufacturing (CMC)
1970/08/11 SUPPL-52(补充) Approval Manufacturing (CMC)
1970/07/24 SUPPL-55(补充) Approval Labeling
1970/06/15 SUPPL-54(补充) Approval Labeling
1970/05/25 SUPPL-53(补充) Approval Labeling
1970/04/17 SUPPL-51(补充) Approval Labeling
1970/04/07 SUPPL-50(补充) Approval Labeling
1969/07/08 SUPPL-49(补充) Approval Labeling
1969/03/04 SUPPL-47(补充) Approval Manufacturing (CMC)
1968/08/14 SUPPL-46(补充) Approval Manufacturing (CMC)
1968/07/02 SUPPL-45(补充) Approval Labeling
1967/12/18 SUPPL-44(补充) Approval Labeling
1967/08/11 SUPPL-43(补充) Approval Labeling
1967/07/20 SUPPL-42(补充) Approval Labeling
1967/07/20 SUPPL-41(补充) Approval Labeling
1967/04/06 SUPPL-40(补充) Approval Labeling
1967/03/20 SUPPL-36(补充) Approval Labeling
1967/03/03 SUPPL-39(补充) Approval Labeling
1967/03/03 SUPPL-38(补充) Approval Labeling
1967/02/24 SUPPL-37(补充) Approval Labeling
1967/02/10 SUPPL-35(补充) Approval Labeling
1967/01/20 SUPPL-34(补充) Approval Labeling
1967/01/13 SUPPL-32(补充) Approval Labeling
1966/11/03 SUPPL-30(补充) Approval Labeling
1966/08/26 SUPPL-28(补充) Approval Labeling
1966/05/12 SUPPL-25(补充) Approval Labeling
1965/06/08 SUPPL-23(补充) Approval Labeling
1965/04/06 SUPPL-22(补充) Approval Labeling
1965/03/22 SUPPL-21(补充) Approval Labeling
1965/01/12 SUPPL-20(补充) Approval Labeling
1965/01/11 SUPPL-19(补充) Approval Labeling
1965/01/06 SUPPL-18(补充) Approval Labeling
1964/12/22 SUPPL-17(补充) Approval Labeling
1963/10/17 SUPPL-15(补充) Approval Labeling
1963/10/04 SUPPL-14(补充) Approval Labeling
1963/07/24 SUPPL-12(补充) Approval Labeling
1962/06/01 SUPPL-10(补充) Approval Labeling
1962/05/24 SUPPL-8(补充) Approval Labeling
1962/05/24 SUPPL-7(补充) Approval Labeling
1960/09/06 SUPPL-3(补充) Approval Manufacturing (CMC)
1957/03/26 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)
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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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