药品注册申请号：050207
申请类型：NDA (新药申请)
申请人：CARNEGIE
申请人全名：CARNEGIE PHARMACEUTICALS LLC
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 E.E.S. ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Yes No AB 1965/04/02 Approved Prior to Jan 1, 1982 Prescription
002 ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 400MG BASE/5ML Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
003 ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Yes No AB 1987/03/30 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1965/04/02 ORIG-1（原始申请） Approval UNKNOWN
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/04/23 SUPPL-74（补充） Approval Labeling-Package Insert STANDARD
2017/08/17 SUPPL-73（补充） Approval Labeling-Package Insert STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2012/02/02 SUPPL-71（补充） Approval Labeling-Package Insert STANDARD
2011/01/26 SUPPL-64（补充） Approval Labeling STANDARD
2010/11/04 SUPPL-67（补充） Approval Labeling STANDARD
2008/12/10 SUPPL-68（补充） Approval Labeling STANDARD
2008/05/22 SUPPL-66（补充） Approval Labeling STANDARD
2008/01/05 SUPPL-65（补充） Approval Labeling STANDARD
2006/08/10 SUPPL-58（补充） Approval Labeling STANDARD
2004/03/12 SUPPL-61（补充） Approval Labeling STANDARD
2002/04/25 SUPPL-57（补充） Approval Labeling STANDARD
2000/02/04 SUPPL-55（补充） Approval Labeling STANDARD
2000/02/04 SUPPL-54（补充） Approval Labeling STANDARD
1999/11/24 SUPPL-56（补充） Approval Manufacturing (CMC)-Control
1997/05/09 SUPPL-53（补充） Approval Manufacturing (CMC)-Control
1997/04/29 SUPPL-52（补充） Approval Manufacturing (CMC)-Control
1997/04/14 SUPPL-51（补充） Approval Labeling
1997/04/14 SUPPL-50（补充） Approval Labeling
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 CARNEGIE
050207 003 NDA ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription Yes No AB 1987/03/30 CARNEGIE
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 CARNEGIE
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 CARNEGIE
050207 003 NDA ERYPED ERYTHROMYCIN ETHYLSUCCINATE GRANULE;ORAL EQ 200MG BASE/5ML Prescription Yes No AB 1987/03/30 CARNEGIE
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
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药品NDC数据与药品包装、标签说明书
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