药品注册申请号:207355
申请类型:ANDA (仿制药申请)
申请人:ACTAVIS LABS FL INC
申请人全名:ACTAVIS LABORATORIES FL INC
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 POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG No No AB 2022/11/30 2022/11/30 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
2022/11/30 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:POSACONAZOLE 剂型/给药途径:TABLET, DELAYED RELEASE;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
205053 001 NDA NOXAFIL POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Discontinued Yes No AB 2013/11/25 MERCK SHARP DOHME
212411 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2019/08/21 SINOTHERAPEUTICS INC
213454 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No Yes AB 2021/02/01 AET PHARMA
214476 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2022/02/04 BIOCON PHARMA
212500 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2022/04/07 DR REDDYS
212226 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2022/05/10 SPECGX LLC
207355 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Discontinued No No AB 2022/11/30 ACTAVIS LABS FL INC
214321 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2022/12/08 HETERO LABS LTD III
216626 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2022/12/22 AMNEAL
216326 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2023/06/20 WESTMINSTER PHARMS
216488 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2023/08/28 I 3 PHARMS
217119 001 ANDA POSACONAZOLE POSACONAZOLE TABLET, DELAYED RELEASE;ORAL 100MG Prescription No No AB 2024/07/18 AUROBINDO PHARMA
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药品NDC数据与药品包装、标签说明书
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