药品注册申请号:012157
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US 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 NORFLEX ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1959/11/04 Approved Prior to Jan 1, 1982 Discontinued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
2007/04/02 SUPPL-28(补充) Approval Labeling STANDARD
1997/09/12 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1996/04/16 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1995/05/11 SUPPL-22(补充) Approval Labeling
1994/10/11 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1989/03/13 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1988/07/26 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1980/08/26 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1980/07/21 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1978/03/13 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1975/11/03 SUPPL-12(补充) Approval Labeling
1959/11/04 ORIG-1(原始申请) Approval Type 2 - New Active Ingredient 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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药品NDC数据与药品包装、标签说明书
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