药品注册申请号：210891
申请类型：ANDA (仿制药申请)
申请人：YILING
申请人全名：YILING PHARMACEUTICAL LTD
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 PREGABALIN PREGABALIN CAPSULE;ORAL 75MG No No AB 2019/09/30 2019/09/30 Prescription
002 PREGABALIN PREGABALIN CAPSULE;ORAL 300MG No No AB 2019/09/30 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
2019/09/30 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:PREGABALIN 剂型/给药途径:CAPSULE;ORAL 规格:75MG 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
021446 003 NDA LYRICA PREGABALIN CAPSULE;ORAL 75MG Prescription Yes No AB 2004/12/30 UPJOHN
091224 001 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 TEVA PHARMS
203459 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 ALEMBIC
208677 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 SCIEGEN PHARMS INC
209357 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 MSN
209664 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 DR REDDYS
209743 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 AMNEAL PHARMS CO
207799 001 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
210432 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 RISING
211384 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/07/19 INVAGEN PHARMS
210891 001 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/09/30 YILING
206912 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/10/08 HETERO LABS LTD III
091157 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Discontinued No No AB 2019/11/29 SUN PHARM
210585 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2019/12/26 RENATA
212280 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2020/01/10 CIPLA
212865 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2020/03/20 CHARTWELL RX
213423 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2020/03/23 CREEKWOOD PHARMS
091025 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2020/07/09 ACTAVIS ELIZABETH
211685 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2021/07/07 APOTEX
214322 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2021/07/15 CHANGZHOU PHARM
212988 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2022/03/08 ESKAYEF
091040 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Discontinued No No AB 2022/05/03 LUPIN LTD
216197 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2022/07/18 ADAPTIS
207883 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2022/09/01 PRINSTON INC
206752 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Discontinued No No AB 2022/12/09 ZYDUS PHARMS
205321 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2023/03/29 AUROBINDO PHARMA
215755 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2023/04/26 ACI
206452 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Discontinued No No AB 2023/07/12 CADILA PHARMS LTD
209883 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 75MG Prescription No No AB 2024/01/24 STRIDES PHARMA
活性成分:PREGABALIN 剂型/给药途径:CAPSULE;ORAL 规格:300MG 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
021446 008 NDA LYRICA PREGABALIN CAPSULE;ORAL 300MG Prescription Yes Yes AB 2004/12/30 UPJOHN
091224 006 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 TEVA PHARMS
203459 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 ALEMBIC
208677 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 SCIEGEN PHARMS INC
209357 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 MSN
209664 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 DR REDDYS
209743 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 AMNEAL PHARMS CO
207799 006 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
210432 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 RISING
211384 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/07/19 INVAGEN PHARMS
210891 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/09/30 YILING
206912 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/10/08 HETERO LABS LTD III
091157 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Discontinued No No AB 2019/11/29 SUN PHARM
210585 006 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2019/12/26 RENATA
212280 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2020/01/10 CIPLA
213423 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2020/03/23 CREEKWOOD PHARMS
091025 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2020/07/09 ACTAVIS ELIZABETH
211685 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2021/07/07 APOTEX
214322 007 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2021/07/15 CHANGZHOU PHARM
212988 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2022/03/08 ESKAYEF
091040 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Discontinued No No AB 2022/05/03 LUPIN LTD
216197 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2022/07/18 ADAPTIS
207883 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2022/09/01 PRINSTON INC
206752 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Discontinued No No AB 2022/12/09 ZYDUS PHARMS
205321 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2023/03/29 AUROBINDO PHARMA
215755 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2023/04/26 ACI
206452 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Discontinued No No AB 2023/07/12 CADILA PHARMS LTD
209883 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 300MG Prescription No No AB 2024/01/24 STRIDES PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database