药品注册申请号:212513
申请类型:ANDA (仿制药申请)
申请人:BE PHARMS
申请人全名:BE PHARMACEUTICALS AG
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 DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL No No AP 2019/06/26 2019/06/26 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
2022/11/13 SUPPL-7(补充) Approval Labeling STANDARD
2022/11/13 SUPPL-5(补充) Approval Labeling STANDARD
2022/11/13 SUPPL-3(补充) Approval Labeling STANDARD
2019/06/26 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:DAPTOMYCIN 剂型/给药途径:POWDER;INTRAVENOUS 规格:500MG/VIAL 治疗等效代码:AP
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
091039 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2016/03/25 TEVA PHARMS USA
206005 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2016/06/15 XELLIA PHARMS APS
206077 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2018/04/11 FRESENIUS KABI USA
205037 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2018/06/05 MYLAN LABS LTD
208375 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2019/05/01 DR REDDYS
211961 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2019/06/24 ACCORD HLTHCARE
212513 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2019/06/26 BE PHARMS
212022 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2019/08/22 HENGRUI PHARMA
207104 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2019/11/15 SAGENT PHARMS INC
212250 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2021/04/21 HISUN PHARM HANGZHOU
213623 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2021/06/29 MEITHEAL
215316 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No Yes AP 2021/08/24 QILU PHARM HAINAN
213171 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2021/09/02 EUGIA PHARMA
215215 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2021/11/26 HANGZHOU ZHONGMEI
215890 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2022/08/18 HAINAN POLY PHARM
216413 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2022/09/23 ASPIRO
213966 001 ANDA DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL Prescription No No AP 2023/08/07 MYLAN
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