药品注册申请号:206297
申请类型:ANDA (仿制药申请)
申请人:AMNEAL PHARMS
申请人全名:AMNEAL PHARMACEUTICALS
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 LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% No No AT 2015/08/07 2015/08/07 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
2018/11/02 SUPPL-8(补充) Approval Labeling STANDARD
2018/04/09 SUPPL-7(补充) Approval Labeling STANDARD
2017/06/20 SUPPL-5(补充) Approval Manufacturing (CMC) UNKNOWN
2017/06/20 SUPPL-3(补充) Approval Manufacturing (CMC) UNKNOWN
2017/06/20 SUPPL-2(补充) Approval Labeling STANDARD
2015/08/07 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:LIDOCAINE 剂型/给药途径:OINTMENT;TOPICAL 规格:5% 治疗等效代码:AT
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
080198 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 FOUGERA PHARMS INC
086724 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT Approved Prior to Jan 1, 1982 TARO
040911 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2011/05/23 SEPTODONT INC
206297 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2015/08/07 AMNEAL PHARMS
205318 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Discontinued No No AT 2016/02/01 ENCUBE
206498 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2016/09/09 GLENMARK PHARMS LTD
207810 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2017/03/10 ALKEM LABS LTD
211469 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2018/11/23 ALEMBIC
210958 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2018/12/11 STRIDES PHARMA
211019 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Discontinued No No AT 2018/12/12 COSETTE
211697 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2020/03/16 MACLEODS PHARMS LTD
208660 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2021/01/05 DR REDDYS
212695 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2021/04/20 QUAGEN
217117 001 ANDA LIDOCAINE LIDOCAINE OINTMENT;TOPICAL 5% Prescription No No AT 2024/06/18 AUROBINDO PHARMA LTD
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