药品注册申请号:050322
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK AND CO 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 NEODECADRON DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE SOLUTION/DROPS;OPHTHALMIC EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML No No None 1969/07/02 Approved Prior to Jan 1, 1982 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
1998/12/29 SUPPL-48(补充) Approval Manufacturing (CMC)
1998/08/31 SUPPL-47(补充) Approval Manufacturing (CMC)
1998/02/24 SUPPL-46(补充) Approval Manufacturing (CMC)
1997/12/23 SUPPL-45(补充) Approval Manufacturing (CMC)
1996/04/16 SUPPL-44(补充) Approval Manufacturing (CMC)
1995/09/29 SUPPL-17(补充) Approval Labeling
1995/09/29 SUPPL-16(补充) Approval Labeling
1995/09/29 SUPPL-15(补充) Approval Labeling
1995/09/29 SUPPL-14(补充) Approval Labeling
1995/09/29 SUPPL-13(补充) Approval Labeling
1995/05/05 SUPPL-42(补充) Approval Manufacturing (CMC)
1995/04/25 SUPPL-43(补充) Approval Manufacturing (CMC)
1987/12/15 SUPPL-12(补充) Approval Manufacturing (CMC)
1987/04/03 SUPPL-11(补充) Approval Labeling
1986/01/22 SUPPL-10(补充) Approval Manufacturing (CMC)
1985/10/30 SUPPL-9(补充) Approval Manufacturing (CMC)
1985/03/07 SUPPL-8(补充) Approval Labeling
1984/08/27 SUPPL-5(补充) Approval Manufacturing (CMC)
1984/06/27 SUPPL-7(补充) Approval Labeling
1984/02/02 SUPPL-4(补充) Approval Manufacturing (CMC)
1983/04/22 SUPPL-3(补充) Approval Manufacturing (CMC)
1983/02/25 SUPPL-2(补充) Approval Manufacturing (CMC)
1981/01/13 SUPPL-41(补充) Approval Labeling
1980/08/28 SUPPL-40(补充) Approval Labeling
1980/08/06 SUPPL-39(补充) Approval Manufacturing (CMC)
1980/03/27 SUPPL-38(补充) Approval Manufacturing (CMC)
1980/02/27 SUPPL-37(补充) Approval Manufacturing (CMC)
1978/03/28 SUPPL-36(补充) Approval Manufacturing (CMC)
1978/01/24 SUPPL-35(补充) Approval Manufacturing (CMC)
1977/05/16 SUPPL-34(补充) Approval Labeling
1977/04/18 SUPPL-33(补充) Approval Labeling
1977/04/12 SUPPL-32(补充) Approval Labeling
1976/03/15 SUPPL-31(补充) Approval Manufacturing (CMC)
1976/01/09 SUPPL-30(补充) Approval Labeling
1975/10/17 SUPPL-29(补充) Approval Manufacturing (CMC)
1975/07/08 SUPPL-28(补充) Approval Manufacturing (CMC)
1973/12/17 SUPPL-27(补充) Approval Labeling
1973/04/23 SUPPL-26(补充) Approval Manufacturing (CMC)
1972/09/13 SUPPL-25(补充) Approval Labeling
1972/07/18 SUPPL-24(补充) Approval Manufacturing (CMC)
1972/04/27 SUPPL-23(补充) Approval Manufacturing (CMC)
1971/06/18 SUPPL-22(补充) Approval Manufacturing (CMC)
1971/04/21 SUPPL-21(补充) Approval Manufacturing (CMC)
1970/04/30 SUPPL-20(补充) Approval Labeling
1970/04/14 SUPPL-19(补充) Approval Manufacturing (CMC)
1970/03/02 SUPPL-18(补充) Approval Manufacturing (CMC)
1970/02/06 SUPPL-6(补充) Approval Manufacturing (CMC)
1969/07/02 ORIG-1(原始申请) Approval
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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