药品注册申请号:070589
申请类型:ANDA (仿制药申请)
申请人:UPSHER SMITH LABS
申请人全名:UPSHER SMITH LABORATORIES 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 AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG No No AB 1987/01/07 1986/08/05 Prescription
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
2014/07/28 SUPPL-44(补充) Approval Manufacturing (CMC)
2012/01/11 SUPPL-45(补充) Approval Labeling
2009/06/05 SUPPL-40(补充) Approval Labeling
2009/02/09 SUPPL-38(补充) Approval Labeling
2007/11/19 SUPPL-37(补充) Approval Labeling
2004/11/17 SUPPL-29(补充) Approval Labeling
2003/10/31 SUPPL-26(补充) Approval Labeling
2003/03/26 SUPPL-24(补充) Approval Labeling
1997/12/16 SUPPL-21(补充) Approval Labeling
1996/10/18 SUPPL-20(补充) Approval Labeling
1996/10/18 SUPPL-19(补充) Approval Manufacturing (CMC)
1996/10/18 SUPPL-18(补充) Approval Manufacturing (CMC)
1996/10/18 SUPPL-17(补充) Approval Manufacturing (CMC)
1996/10/18 SUPPL-16(补充) Approval Manufacturing (CMC)
1995/05/09 SUPPL-15(补充) Approval Manufacturing (CMC)
1995/05/09 SUPPL-14(补充) Approval Manufacturing (CMC)
1993/09/24 SUPPL-13(补充) Approval Manufacturing (CMC)
1993/09/24 SUPPL-12(补充) Approval Manufacturing (CMC)
1993/09/24 SUPPL-11(补充) Approval Manufacturing (CMC)
1993/09/24 SUPPL-10(补充) Approval Manufacturing (CMC)
1993/09/24 SUPPL-9(补充) Approval Manufacturing (CMC)
1991/10/16 SUPPL-8(补充) Approval Labeling
1991/02/26 SUPPL-7(补充) Approval Labeling
1991/02/26 SUPPL-6(补充) Approval Labeling
1989/03/27 SUPPL-5(补充) Approval Manufacturing (CMC)
1988/08/26 SUPPL-4(补充) Approval Labeling
1988/05/05 SUPPL-2(补充) Approval Manufacturing (CMC)
1987/01/07 SUPPL-1(补充) Approval Manufacturing (CMC)
1987/01/07 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:AMANTADINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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
070589 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 1986/08/05 UPSHER SMITH LABS
071293 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 1987/02/18 SANDOZ
078720 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No Yes AB 2008/05/29 BIONPHARMA
208278 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2016/05/31 ZYDUS PHARMS
208107 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Discontinued No No AB 2016/12/06 WATSON LABS INC
209047 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2017/06/07 STRIDES PHARMA
209171 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2017/06/12 HERITAGE PHARMA
208966 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2017/06/21 ALEMBIC
210129 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2020/03/02 RISING
212044 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2020/05/21 RUBICON
211354 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2022/02/18 STRIDES PHARMA
214580 001 ANDA AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE;ORAL 100MG Prescription No No AB 2022/12/20 HUMANWELL PURACAP
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