药品注册申请号:088833
申请类型:ANDA (仿制药申请)
申请人:WOCKHARDT
申请人全名:WOCKHARDT EU OPERATIONS (SWISS) AG
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 TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;30MG/5ML;1.25MG/5ML No No None 1984/11/16 1984/11/16 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
1998/12/01 SUPPL-23(补充) Approval Labeling
1990/11/20 SUPPL-20(补充) Approval Labeling
1990/05/24 SUPPL-19(补充) Approval Labeling
1990/01/22 SUPPL-18(补充) Approval Labeling
1989/02/13 SUPPL-17(补充) Approval Manufacturing (CMC)
1987/08/10 SUPPL-12(补充) Approval Manufacturing (CMC)
1987/08/10 SUPPL-11(补充) Approval Manufacturing (CMC)
1987/05/14 SUPPL-15(补充) Approval Manufacturing (CMC)
1987/05/14 SUPPL-14(补充) Approval Manufacturing (CMC)
1986/12/18 SUPPL-9(补充) Approval Manufacturing (CMC)
1986/05/30 SUPPL-10(补充) Approval Manufacturing (CMC)
1985/07/24 SUPPL-7(补充) Approval Manufacturing (CMC)
1984/12/13 SUPPL-5(补充) Approval Manufacturing (CMC)
1984/12/13 SUPPL-4(补充) Approval Manufacturing (CMC)
1984/12/13 SUPPL-3(补充) Approval Manufacturing (CMC)
1984/12/13 SUPPL-2(补充) Approval Manufacturing (CMC)
1984/12/13 SUPPL-1(补充) Approval Manufacturing (CMC)
1984/11/16 ORIG-1(原始申请) Approval
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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