药品注册申请号:021045
申请类型:NDA (新药申请)
申请人:FDN CONSUMER
申请人全名:FOUNDATION CONSUMER HEALTHCARE 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
001 PLAN B LEVONORGESTREL TABLET;ORAL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1999/07/28 1999/07/28 Discontinued
002 PLAN B LEVONORGESTREL TABLET;ORAL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2006/08/24 Discontinued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
2018/04/24 SUPPL-17(补充) Approval Labeling STANDARD
2017/09/28 SUPPL-16(补充) Approval Labeling STANDARD
2009/07/10 SUPPL-15(补充) Approval Efficacy STANDARD
2006/08/24 SUPPL-11(补充) Approval Efficacy UNKNOWN
2002/06/21 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
2002/02/13 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
2001/02/28 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
2000/12/13 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
2000/06/30 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
2000/05/24 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/12 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
2000/03/28 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1999/07/28 ORIG-1(原始申请) Approval Type 3 - New Dosage Form and Type 4 - New Combination 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
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
002 NP 2009/08/24**本条是由Drugfuture回溯的历史信息**
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
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