药品注册申请号：207521
申请类型：ANDA (仿制药申请)
申请人：SOMERSET
申请人全名：SOMERSET THERAPEUTICS 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 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML No No AP 2018/06/08 2018/06/08 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
2018/06/08 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
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:DEXAMETHASONE SODIUM PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 4MG PHOSPHATE/ML 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
084282 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP Approved Prior to Jan 1, 1982 WEST-WARD PHARMS INT
084916 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
040803 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2008/08/29 MYLAN LABS LTD
203129 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2015/09/30 FRESENIUS KABI USA
206781 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2015/12/01 EUGIA PHARMA
207521 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2018/06/08 SOMERSET
208689 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2018/08/22 AMNEAL
215654 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2021/08/04 GLAND PHARMA LTD
214891 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Discontinued No No AP 2023/07/28 GENEYORK PHARMS
211451 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML Prescription No No AP 2023/08/01 HIKMA
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药品NDC数据与药品包装、标签说明书
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