药品注册申请号:087846
申请类型:ANDA (仿制药申请)
申请人:SPECGX LLC
申请人全名:SPECGX 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 TOFRANIL IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Yes No AB 1984/05/22 1984/05/22 Discontinued
002 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Yes No AB 1984/05/22 Discontinued
003 IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Yes No AB 1984/05/22 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
2017/06/29 SUPPL-29(补充) Approval Labeling STANDARD
2014/07/17 SUPPL-28(补充) Approval Labeling STANDARD
2007/09/27 SUPPL-26(补充) Approval Labeling
2007/06/25 SUPPL-25(补充) Approval Labeling
2005/09/12 SUPPL-23(补充) Approval Labeling
2005/06/09 SUPPL-22(补充) Approval Labeling
2004/08/31 SUPPL-21(补充) Approval Labeling
2002/06/12 SUPPL-20(补充) Approval Manufacturing (CMC)
2000/09/14 SUPPL-19(补充) Approval Manufacturing (CMC)
2000/09/14 SUPPL-18(补充) Approval Manufacturing (CMC)
1999/07/15 SUPPL-17(补充) Approval Manufacturing (CMC)
1998/09/01 SUPPL-15(补充) Approval Labeling
1997/09/26 SUPPL-16(补充) Approval Manufacturing (CMC)
1994/12/20 SUPPL-13(补充) Approval Labeling
1993/02/25 SUPPL-12(补充) Approval Manufacturing (CMC)
1993/02/02 SUPPL-10(补充) Approval Labeling
1992/12/14 SUPPL-11(补充) Approval Manufacturing (CMC)
1992/12/14 SUPPL-8(补充) Approval Manufacturing (CMC)
1986/10/23 SUPPL-7(补充) Approval Manufacturing (CMC)
1986/07/25 SUPPL-6(补充) Approval Manufacturing (CMC)
1986/07/25 SUPPL-5(补充) Approval Manufacturing (CMC)
1984/05/22 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
活性成分:IMIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
084937 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB Approved Prior to Jan 1, 1982 SANDOZ
088276 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1983/10/21 STRIDES PHARMA
087846 001 ANDA TOFRANIL IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued Yes No AB 1984/05/22 SPECGX LLC
081050 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1990/06/05 SUN PHARM INDUSTRIES
040751 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2008/02/28 OXFORD PHARMS
040903 003 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No Yes AB 2012/10/24 LEADING
活性成分:IMIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
084936 002 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB Approved Prior to Jan 1, 1982 SANDOZ
088292 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1983/10/21 STRIDES PHARMA
087846 002 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued Yes No AB 1984/05/22 SPECGX LLC
081048 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 1990/06/05 SUN PHARM INDUSTRIES
040751 003 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/02/28 OXFORD PHARMS
040903 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2012/10/24 LEADING
活性成分:IMIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
083745 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB Approved Prior to Jan 1, 1982 SANDOZ
088262 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 1983/10/21 STRIDES PHARMA
087846 003 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued Yes No AB 1984/05/22 SPECGX LLC
081049 001 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 1990/06/05 SUN PHARM INDUSTRIES
040751 002 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2008/02/28 OXFORD PHARMS
040903 002 ANDA IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2012/10/24 LEADING
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