药品注册申请号：204940
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS
申请人全名：AMNEAL PHARMACEUTICALS OF NEW YORK 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 OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS No No AB 2015/11/27 2015/11/27 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
2021/01/06 SUPPL-10（补充） Approval Labeling STANDARD
2020/02/24 SUPPL-7（补充） Approval Labeling STANDARD
2015/11/27 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:OMEGA-3-ACID ETHYL ESTERS 剂型/给药途径:CAPSULE;ORAL 规格:1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS 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
021654 001 NDA LOVAZA OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription Yes Yes AB 2004/11/10 WOODWARD
091028 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2014/04/07 GLW
090973 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2014/09/30 APOTEX
204940 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2015/11/27 AMNEAL PHARMS
203893 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2017/09/19 STRIDES SOFTGELS
207420 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2019/02/25 ASCENT PHARMS INC
211355 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2019/07/10 SOFGEN PHARMS
206455 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2019/08/07 CHARTWELL
210834 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2020/01/09 SUN PHARM
211979 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2020/05/12 CSPC-NBP PHARM
210093 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2020/06/15 PURACAP PHARM LLC
212504 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2020/08/19 GLW
215458 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2021/11/15 MANKIND PHARMA
211345 001 ANDA OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Prescription No No AB 2023/12/07 WILSHIRE PHARMS INC
更多信息
药品NDC数据与药品包装、标签说明书
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