药品注册申请号:201952
申请类型:ANDA (仿制药申请)
申请人:MICRO LABS LTD INDIA
申请人全名:MICRO LABS LTD INDIA
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 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG No No AB 2012/12/14 2012/12/14 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
2023/12/15 SUPPL-14(补充) Approval Labeling STANDARD
2022/08/03 SUPPL-13(补充) Approval Labeling STANDARD
2022/08/03 SUPPL-12(补充) Approval Labeling STANDARD
2022/08/03 SUPPL-11(补充) Approval Labeling STANDARD
2022/08/03 SUPPL-10(补充) Approval Labeling STANDARD
2022/08/03 SUPPL-8(补充) Approval Labeling STANDARD
2022/08/03 SUPPL-7(补充) Approval Labeling STANDARD
2018/09/18 SUPPL-9(补充) Approval REMS
2017/03/23 SUPPL-6(补充) Approval Labeling STANDARD
2014/08/01 SUPPL-1(补充) Approval Labeling STANDARD
2012/12/14 ORIG-1(原始申请) Approval Not Applicable
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:ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;37.5MG 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
021123 001 NDA ULTRACET ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Discontinued Yes No AB 2001/08/15 JANSSEN PHARMS
077184 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No No AB 2005/12/16 SUN PHARM INDS INC
077858 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No No AB 2008/09/26 RISING
090485 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No Yes AB 2009/12/09 AMNEAL PHARMS
202076 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No No AB 2012/03/30 ALKEM LABS LTD
090460 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No No AB 2012/09/06 ZYDUS PHARMS USA INC
201952 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No No AB 2012/12/14 MICRO LABS LTD INDIA
207152 001 ANDA TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE TABLET;ORAL 325MG;37.5MG Prescription No No AB 2017/03/22 AUROBINDO PHARMA
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