药品注册申请号:213456
申请类型:ANDA (仿制药申请)
申请人:UNITED RES LABS
申请人全名:UNITED RESEARCH 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 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG No No AB 2022/01/21 2022/01/21 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
2022/01/21 ORIG-1(原始申请) Approval STANDARD
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:COLESEVELAM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:625MG 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
021176 001 NDA WELCHOL COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription Yes Yes AB 2000/05/26 COSETTE
091600 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2018/05/16 IMPAX LABS INC
203480 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2018/05/18 GLENMARK PHARMS LTD
209038 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2018/10/05 ALKEM LABS LTD
210889 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2018/10/05 DR REDDYS
208670 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2019/09/13 BIONPHARMA
207765 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2019/10/07 ZYDUS PHARMS
209946 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2020/07/15 ZHEJIANG JINGXIN
212050 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2020/12/04 INVENTIA
206036 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Prescription No No AB 2021/10/14 BEIJING TIDE PHARM
213456 001 ANDA COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE TABLET;ORAL 625MG Discontinued No No AB 2022/01/21 UNITED RES LABS
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