药品注册申请号：015921
申请类型：NDA (新药申请)
申请人：ORTHO MCNEIL
申请人全名：ORTHO MCNEIL PHARMACEUTICAL
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001 HALDOL HALOPERIDOL TABLET;ORAL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1967/04/12 Approved Prior to Jan 1, 1982 Discontinued
002 HALDOL HALOPERIDOL TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 HALDOL HALOPERIDOL TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 HALDOL HALOPERIDOL TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 HALDOL HALOPERIDOL TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 HALDOL HALOPERIDOL TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/02/02 Discontinued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
2002/04/17 SUPPL-76（补充） Approval Labeling PRIORITY
2000/05/02 SUPPL-75（补充） Approval Labeling PRIORITY
1998/04/23 SUPPL-71（补充） Approval Manufacturing (CMC) PRIORITY
1996/05/10 SUPPL-72（补充） Approval Manufacturing (CMC) PRIORITY
1995/01/30 SUPPL-68（补充） Approval Manufacturing (CMC) PRIORITY
1994/06/29 SUPPL-67（补充） Approval Manufacturing (CMC) PRIORITY
1990/04/06 SUPPL-65（补充） Approval Manufacturing (CMC) PRIORITY
1988/10/04 SUPPL-62（补充） Approval Manufacturing (CMC) PRIORITY
1988/02/17 SUPPL-61（补充） Approval Manufacturing (CMC) PRIORITY
1987/10/16 SUPPL-59（补充） Approval Manufacturing (CMC) PRIORITY
1986/10/22 SUPPL-53（补充） Approval Manufacturing (CMC) PRIORITY
1986/02/06 SUPPL-48（补充） Approval Manufacturing (CMC) PRIORITY
1985/04/30 SUPPL-47（补充） Approval Manufacturing (CMC) PRIORITY
1985/04/30 SUPPL-46（补充） Approval Manufacturing (CMC) PRIORITY
1983/03/18 SUPPL-40（补充） Approval Manufacturing (CMC) PRIORITY
1983/03/18 SUPPL-39（补充） Approval Manufacturing (CMC) PRIORITY
1983/03/18 SUPPL-38（补充） Approval Manufacturing (CMC) PRIORITY
1983/03/11 SUPPL-37（补充） Approval Labeling PRIORITY
1983/01/31 SUPPL-36（补充） Approval Labeling PRIORITY
1982/09/08 SUPPL-35（补充） Approval Labeling PRIORITY
1982/09/03 SUPPL-34（补充） Approval Manufacturing (CMC) PRIORITY
1982/06/23 SUPPL-32（补充） Approval Manufacturing (CMC) PRIORITY
1982/04/20 SUPPL-33（补充） Approval Manufacturing (CMC) PRIORITY
1982/02/02 SUPPL-26（补充） Approval Manufacturing (CMC) PRIORITY
1981/10/02 SUPPL-31（补充） Approval Labeling PRIORITY
1981/01/23 SUPPL-29（补充） Approval Labeling PRIORITY
1981/01/23 SUPPL-28（补充） Approval Labeling PRIORITY
1980/03/07 SUPPL-27（补充） Approval Manufacturing (CMC) PRIORITY
1980/02/12 SUPPL-24（补充） Approval Labeling PRIORITY
1979/07/06 SUPPL-25（补充） Approval Labeling PRIORITY
1978/02/13 SUPPL-21（补充） Approval Labeling PRIORITY
1977/12/12 SUPPL-23（补充） Approval Manufacturing (CMC) PRIORITY
1976/03/26 SUPPL-20（补充） Approval Manufacturing (CMC) PRIORITY
1974/12/10 SUPPL-19（补充） Approval Manufacturing (CMC) PRIORITY
1974/05/21 SUPPL-12（补充） Approval REMS PRIORITY
1967/04/12 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
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
无
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
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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