药品注册申请号:201831
申请类型:ANDA (仿制药申请)
申请人:GLENMARK PHARMS LTD
申请人全名:GLENMARK PHARMACEUTICALS LTD
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 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG No No AB 2015/05/28 2015/05/28 Prescription
002 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG No No AB 2015/05/28 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
2015/05/28 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:DESMOPRESSIN ACETATE 剂型/给药途径:TABLET;ORAL 规格:0.1MG 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
019955 001 NDA DDAVP DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription Yes No AB 1995/09/06 FERRING PHARMS INC
076470 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Discontinued No No AB 2005/07/01 ACTAVIS LABS FL INC
077414 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription No No AB 2006/03/07 APOTEX INC
201831 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription No No AB 2015/05/28 GLENMARK PHARMS LTD
207880 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription No No AB 2017/05/26 HERITAGE PHARMA
210371 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription No No AB 2019/01/28 ABHAI LLC
208357 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription No No AB 2019/06/06 NOVAST LABS
213095 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.1MG Prescription No No AB 2024/03/21 AUROBINDO PHARMA
活性成分:DESMOPRESSIN ACETATE 剂型/给药途径:TABLET;ORAL 规格:0.2MG 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
019955 002 NDA DDAVP DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription Yes Yes AB 1995/09/06 FERRING PHARMS INC
076470 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Discontinued No No AB 2005/07/01 ACTAVIS LABS FL INC
077414 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription No No AB 2006/03/07 APOTEX INC
201831 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription No No AB 2015/05/28 GLENMARK PHARMS LTD
207880 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription No No AB 2017/05/26 HERITAGE PHARMA
210371 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription No No AB 2019/01/28 ABHAI LLC
208357 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription No No AB 2019/06/06 NOVAST LABS
213095 002 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE TABLET;ORAL 0.2MG Prescription No No AB 2024/03/21 AUROBINDO PHARMA
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