药品注册申请号:207442
申请类型:ANDA (仿制药申请)
申请人:SOMERSET THERAPS LLC
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 PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML No No AP 2018/04/19 2018/04/19 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
2024/06/05 SUPPL-16(补充) Approval Labeling STANDARD
2021/05/12 SUPPL-4(补充) Approval Labeling STANDARD
2018/04/19 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:DEXAMETHASONE SODIUM PHOSPHATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 10MG 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
087702 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No Yes AP 1982/09/07 HIKMA
040491 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No Yes AP 2003/04/11 FRESENIUS KABI USA
040572 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No Yes AP 2005/04/22 FRESENIUS KABI USA
040802 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2008/08/29 MYLAN LABS LTD
207442 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2018/04/19 SOMERSET THERAPS LLC
209192 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2018/07/06 FRESENIUS KABI USA
208690 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2018/08/22 AMNEAL
211036 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2019/05/10 SOMERSET THERAPS LLC
210967 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2019/06/07 EUGIA PHARMA
210966 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2020/06/05 EUGIA PHARMA
214890 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Discontinued No No AP 2023/07/07 GENEYORK PHARMS
215654 002 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2023/09/25 GLAND PHARMA LTD
217797 001 ANDA DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 10MG PHOSPHATE/ML Prescription No No AP 2024/03/27 MICRO LABS
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