药品注册申请号:018733
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS 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 TALWIN NX NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE TABLET;ORAL EQ 0.5MG BASE;EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1982/12/16 1982/12/16 Discontinued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
2011/02/24 SUPPL-15(补充) Approval Labeling PRIORITY
2008/09/01 SUPPL-14(补充) Approval Labeling PRIORITY
2003/02/26 SUPPL-12(补充) Approval Labeling PRIORITY
1989/01/12 SUPPL-10(补充) Approval Labeling PRIORITY
1989/01/12 SUPPL-7(补充) Approval Labeling PRIORITY
1988/02/29 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1987/02/02 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1985/10/09 SUPPL-8(补充) Approval Labeling PRIORITY
1983/04/05 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1983/04/05 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1983/04/05 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1983/04/05 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1983/04/05 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1983/04/05 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1982/12/16 ORIG-1(原始申请) Approval Type 4 - New Combination 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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