药品注册申请号:008278
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
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
003 REGITINE PHENTOLAMINE MESYLATE INJECTABLE;INJECTION 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1952/01/30 Approved Prior to Jan 1, 1982 Discontinued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
1999/04/29 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1999/02/05 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1998/11/05 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1998/10/20 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1992/01/09 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1986/04/14 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1985/05/13 SUPPL-11(补充) Approval Labeling
1983/07/27 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1983/07/21 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1981/09/09 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1981/02/18 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1980/01/07 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1977/04/12 SUPPL-6(补充) Approval Labeling
1977/02/11 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1977/02/11 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1952/01/30 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)
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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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