药品注册申请号：062055
申请类型：ANDA (仿制药申请)
申请人：ANI PHARMS
申请人全名：ANI PHARMACEUTICALS 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 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML No No AB 1978/11/27 Approved Prior to Jan 1, 1982 Prescription
002 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 400MG BASE/5ML No No AB 2018/11/02 Prescription
003 ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML No No AB 2018/11/02 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-35（补充） Approval Manufacturing (CMC) UNKNOWN
2018/11/02 SUPPL-34（补充） Approval Manufacturing (CMC) UNKNOWN
2014/04/25 SUPPL-32（补充） Approval Labeling STANDARD
2001/06/01 SUPPL-31（补充） Approval Labeling
2001/05/24 SUPPL-30（补充） Approval Manufacturing (CMC)
2001/02/14 SUPPL-29（补充） Approval Labeling
1999/12/21 SUPPL-28（补充） Approval Manufacturing (CMC)
1999/05/20 SUPPL-27（补充） Approval Manufacturing (CMC)
1998/12/01 SUPPL-25（补充） Approval Manufacturing (CMC)
1998/10/08 SUPPL-26（补充） Approval Labeling
1998/09/25 SUPPL-24（补充） Approval Manufacturing (CMC)
1995/09/22 SUPPL-23（补充） Approval Manufacturing (CMC)
1994/12/23 SUPPL-22（补充） Approval Manufacturing (CMC)
1994/10/11 SUPPL-21（补充） Approval Manufacturing (CMC)
1993/07/01 SUPPL-20（补充） Approval Labeling
1992/04/29 SUPPL-15（补充） Approval Manufacturing (CMC)
1992/04/03 SUPPL-19（补充） Approval Manufacturing (CMC)
1992/04/03 SUPPL-17（补充） Approval Manufacturing (CMC)
1992/02/25 SUPPL-16（补充） Approval Labeling
1978/11/27 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
无
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
无
与本品治疗等效的药品
活性成分:ERYTHROMYCIN ETHYLSUCCINATE 剂型/给药途径:GRANULE;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
062055 001 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB Approved Prior to Jan 1, 1982 ANI PHARMS
050207 001 NDA E.E.S. ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription Yes No AB Approved Prior to Jan 1, 1982 AZURITY
050207 003 NDA ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription Yes No AB 1987/03/30 AZURITY
062055 003 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB 2018/11/02 ANI PHARMS
211204 001 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB 2019/11/01 AMNEAL PHARMS
216212 001 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB 2022/11/21 CADILA PHARMS LTD
活性成分:ERYTHROMYCIN ETHYLSUCCINATE 剂型/给药途径:GRANULE;ORAL 规格:EQ 400MG 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
050207 002 NDA ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 400MG BASE/5ML Prescription Yes Yes AB Approved Prior to Jan 1, 1982 AZURITY
062055 002 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 400MG BASE/5ML Prescription No No AB 2018/11/02 ANI PHARMS
211204 002 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 400MG BASE/5ML Prescription No No AB 2019/11/01 AMNEAL PHARMS
216212 002 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 400MG BASE/5ML Prescription No No AB 2022/11/21 CADILA PHARMS LTD
活性成分:ERYTHROMYCIN ETHYLSUCCINATE 剂型/给药途径:GRANULE;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
062055 001 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB Approved Prior to Jan 1, 1982 ANI PHARMS
050207 001 NDA E.E.S. ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription Yes No AB Approved Prior to Jan 1, 1982 AZURITY
050207 003 NDA ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription Yes No AB 1987/03/30 AZURITY
062055 003 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB 2018/11/02 ANI PHARMS
211204 001 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB 2019/11/01 AMNEAL PHARMS
216212 001 ANDA ERYTHROMYCIN ETHYLSUCCINATE ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription No No AB 2022/11/21 CADILA PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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