药品注册申请号:006773
申请类型:NDA (新药申请)
申请人:LEDERLE
申请人全名:LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
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 ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1949/05/13 Approved Prior to Jan 1, 1982 Discontinued
005 ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
009 ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE ELIXIR;ORAL 2MG/5ML No No None Approved Prior to Jan 1, 1982 Discontinued
010 ARTANE TRIHEXYPHENIDYL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 5MG No No None 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
2003/06/25 SUPPL-36(补充) Approval Labeling
1998/01/28 SUPPL-35(补充) Approval Manufacturing (CMC)
1997/07/02 SUPPL-34(补充) Approval Manufacturing (CMC)
1997/07/02 SUPPL-33(补充) Approval Manufacturing (CMC)
1997/07/02 SUPPL-32(补充) Approval Manufacturing (CMC)
1997/02/19 SUPPL-31(补充) Approval Manufacturing (CMC)
1997/02/19 SUPPL-30(补充) Approval Manufacturing (CMC)
1997/02/19 SUPPL-29(补充) Approval Manufacturing (CMC)
1996/12/17 SUPPL-28(补充) Approval Manufacturing (CMC)
1996/08/27 SUPPL-27(补充) Approval Manufacturing (CMC)
1993/06/25 SUPPL-26(补充) Approval Manufacturing (CMC)
1987/07/24 SUPPL-22(补充) Approval Labeling
1987/02/26 SUPPL-23(补充) Approval Labeling
1984/06/26 SUPPL-21(补充) Approval Manufacturing (CMC)
1976/03/11 SUPPL-17(补充) Approval Manufacturing (CMC)
1976/03/11 SUPPL-16(补充) Approval Manufacturing (CMC)
1976/03/10 SUPPL-18(补充) Approval Manufacturing (CMC)
1976/01/28 SUPPL-15(补充) Approval Manufacturing (CMC)
1976/01/27 SUPPL-9(补充) Approval REMS
1975/03/11 SUPPL-13(补充) Approval Manufacturing (CMC)
1975/03/10 SUPPL-14(补充) Approval Manufacturing (CMC)
1975/01/29 SUPPL-10(补充) Approval Labeling
1949/05/13 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)
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
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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