药品注册申请号：021654
申请类型：NDA (新药申请)
申请人：WOODWARD
申请人全名：WOODWARD PHARMA SERVICES 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 LOVAZA OMEGA-3-ACID ETHYL ESTERS CAPSULE;ORAL 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS Yes Yes AB 2004/11/10 2004/11/10 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
2020/09/04 SUPPL-44（补充） Approval Labeling STANDARD
2019/04/03 SUPPL-43（补充） Approval Labeling STANDARD
2015/03/09 SUPPL-42（补充） Approval Manufacturing (CMC) STANDARD
2014/06/05 SUPPL-40（补充） Approval Manufacturing (CMC) STANDARD
2014/05/14 SUPPL-41（补充） Approval Labeling STANDARD
2013/11/15 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
2013/09/11 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
2013/06/26 SUPPL-37（补充） Approval Labeling STANDARD
2012/08/31 SUPPL-34（补充） Approval Labeling UNKNOWN
2011/09/19 SUPPL-33（补充） Approval Labeling UNKNOWN
2011/08/11 SUPPL-31（补充） Approval Labeling UNKNOWN
2010/12/22 SUPPL-30（补充） Approval Labeling UNKNOWN
2009/09/16 SUPPL-22（补充） Approval Efficacy STANDARD
2009/04/20 SUPPL-23（补充） Approval Labeling STANDARD
2008/06/03 SUPPL-21（补充） Approval Labeling STANDARD
2008/01/24 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2007/12/06 SUPPL-15（补充） Approval Manufacturing (CMC) N/A
2007/11/07 SUPPL-14（补充） Approval Labeling STANDARD
2007/06/12 SUPPL-16（补充） Approval Labeling STANDARD
2007/02/01 SUPPL-4（补充） Approval Labeling STANDARD
2006/07/03 SUPPL-7（补充） Approval Manufacturing (CMC) N/A
2004/11/10 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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
001 5502077 2013/03/26 Y U-822 PDF格式**本条是由Drugfuture回溯的历史信息**
5656667 2017/04/10 Y Y U-822 PDF格式**本条是由Drugfuture回溯的历史信息**
5656667 2018/08/27 Y Y U-822 PDF格式**本条是由Drugfuture回溯的历史信息**
5698594 2009/08/04 Y U-822 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 M-64 2010/06/12**本条是由Drugfuture回溯的历史信息**
NCE 2009/11/10**本条是由Drugfuture回溯的历史信息**
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 PHARMA
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 SLAYBACK PHARMA LLC
更多信息
药品NDC数据与药品包装、标签说明书
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