药品注册申请号:013220
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
002 PERIACTIN CYPROHEPTADINE HYDROCHLORIDE SYRUP;ORAL 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1962/03/30 Approved Prior to Jan 1, 1982 Discontinued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
1996/06/21 SUPPL-41(补充) Approval Labeling STANDARD
1992/10/16 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
1992/08/05 SUPPL-39(补充) Approval Labeling STANDARD
1989/10/11 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1986/11/04 SUPPL-36(补充) Approval Labeling STANDARD
1986/11/04 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1986/11/04 SUPPL-33(补充) Approval Labeling STANDARD
1986/05/07 SUPPL-34(补充) Approval Labeling STANDARD
1985/10/01 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1984/05/16 SUPPL-31(补充) Approval Labeling STANDARD
1984/04/30 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1983/04/22 SUPPL-29(补充) Approval Labeling STANDARD
1981/05/04 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1980/04/04 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1980/04/04 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1979/08/01 SUPPL-25(补充) Approval Labeling STANDARD
1979/05/29 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1978/10/30 SUPPL-23(补充) Approval Labeling STANDARD
1962/03/30 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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