药品注册申请号:065246
申请类型:ANDA (仿制药申请)
申请人:PLIVA
申请人全名:PLIVA 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 AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML No No AB 2006/07/06 2006/07/05 Prescription
002 AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML No No AB 2006/07/05 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
2023/05/28 SUPPL-30(补充) Approval Labeling STANDARD
2020/01/13 SUPPL-26(补充) Approval Labeling STANDARD
2020/01/13 SUPPL-25(补充) Approval Labeling STANDARD
2017/06/28 SUPPL-24(补充) Approval Labeling STANDARD
2017/06/28 SUPPL-23(补充) Approval Labeling STANDARD
2017/06/28 SUPPL-22(补充) Approval Labeling STANDARD
2017/06/28 SUPPL-19(补充) Approval Labeling STANDARD
2013/07/11 SUPPL-16(补充) Approval Labeling STANDARD
2013/02/28 SUPPL-15(补充) Approval Labeling STANDARD
2012/12/18 SUPPL-14(补充) Approval Labeling STANDARD
2012/02/28 SUPPL-11(补充) Approval Labeling
2009/10/22 SUPPL-5(补充) Approval Labeling
2009/09/28 SUPPL-7(补充) Approval Labeling
2006/07/06 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:AZITHROMYCIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:EQ 200MG BASE/5ML 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
050710 002 NDA ZITHROMAX AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription Yes Yes AB 1995/10/19 PFIZER
065246 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription No No AB 2006/07/05 PLIVA
207531 002 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription No No AB 2018/04/09 EPIC PHARMA LLC
205666 002 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription No No AB 2018/07/19 AMNEAL
211147 002 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription No No AB 2018/07/31 ZYDUS
209201 002 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription No No AB 2018/10/09 AUROBINDO PHARMA LTD
211521 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Discontinued No No AB 2019/12/11 TARO
217036 002 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 200MG BASE/5ML Prescription No No AB 2023/07/27 HAINAN POLY
活性成分:AZITHROMYCIN 剂型/给药途径:FOR SUSPENSION;ORAL 规格:EQ 100MG BASE/5ML 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
050710 001 NDA ZITHROMAX AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription Yes No AB 1995/10/19 PFIZER
065246 002 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription No No AB 2006/07/05 PLIVA
207531 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription No No AB 2018/04/09 EPIC PHARMA LLC
205666 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription No No AB 2018/07/19 AMNEAL
211147 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription No No AB 2018/07/31 ZYDUS
209201 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription No No AB 2018/10/09 AUROBINDO PHARMA LTD
217036 001 ANDA AZITHROMYCIN AZITHROMYCIN FOR SUSPENSION;ORAL EQ 100MG BASE/5ML Prescription No No AB 2023/07/27 HAINAN POLY
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