药品注册申请号:210196
申请类型:ANDA (仿制药申请)
申请人:AUCTA
申请人全名:AUCTA PHARMACEUTICALS INC
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 VIGADRONE VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET No No AA 2018/06/21 2018/06/21 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
2022/10/12 SUPPL-14(补充) Approval REMS
2022/08/08 SUPPL-12(补充) Approval Labeling STANDARD
2022/08/08 SUPPL-6(补充) Approval Labeling STANDARD
2022/08/08 SUPPL-4(补充) Approval Labeling STANDARD
2022/08/08 SUPPL-2(补充) Approval Labeling STANDARD
2020/10/02 SUPPL-7(补充) Approval REMS
2020/04/17 SUPPL-5(补充) Approval REMS
2019/09/12 SUPPL-3(补充) Approval REMS
2019/05/30 SUPPL-1(补充) Approval REMS
2018/06/21 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:VIGABATRIN 剂型/给药途径:FOR SOLUTION;ORAL 规格:500MG/PACKET 治疗等效代码:AA
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
022006 001 NDA SABRIL VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription Yes Yes AA 2009/08/21 LUNDBECK PHARMS LLC
208218 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2017/04/27 PAR PHARM INC
210155 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2018/03/13 AMNEAL PHARMS
209824 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2018/04/23 TEVA PHARMS USA
210196 001 ANDA VIGADRONE VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2018/06/21 AUCTA
211481 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2018/11/20 DR REDDYS
211592 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2019/12/03 INVAGEN PHARMS
213469 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Discontinued No No AA 2020/04/24 GRANULES
214425 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Discontinued No No AA 2020/11/13 ACCORD HLTHCARE
213375 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2020/12/02 ALKEM LABS LTD
213519 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2021/01/26 ANNORA PHARMA
214992 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2021/05/13 DEXCEL
213390 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2021/07/29 PROPEL PHARMA
213899 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2021/09/29 AUROBINDO PHARMA LTD
211790 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Discontinued No No AA 2022/03/10 CHARTWELL RX
214961 001 ANDA VIGPODER VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2022/06/24 PYROS PHARMS
215363 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Prescription No No AA 2022/09/07 MSN
214671 001 ANDA VIGABATRIN VIGABATRIN FOR SOLUTION;ORAL 500MG/PACKET Discontinued No No AA 2023/03/02 ZYDUS
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