药品注册申请号:012052
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 HYDROCORTONE HYDROCORTISONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 50MG BASE/ML Yes No None 1960/06/08 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
1997/12/01 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
1997/05/02 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1997/01/16 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1996/03/01 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1996/02/29 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1993/09/10 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1993/08/26 SUPPL-42(补充) Approval Labeling STANDARD
1989/09/06 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1986/01/15 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1985/03/08 SUPPL-34(补充) Approval Labeling STANDARD
1984/02/23 SUPPL-33(补充) Approval Labeling STANDARD
1982/03/04 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1981/10/16 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1980/01/14 SUPPL-27(补充) Approval Labeling STANDARD
1977/06/27 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1960/06/08 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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