药品注册申请号：212865
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL RX
申请人全名：CHARTWELL RX SCIENCES 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 PREGABALIN PREGABALIN CAPSULE;ORAL 50MG No No AB 2020/03/20 2020/03/20 Prescription
002 PREGABALIN PREGABALIN CAPSULE;ORAL 75MG No No AB 2020/03/20 Prescription
003 PREGABALIN PREGABALIN CAPSULE;ORAL 100MG No No AB 2020/03/20 Prescription
004 PREGABALIN PREGABALIN CAPSULE;ORAL 150MG No No AB 2020/03/20 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
2020/03/20 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:50MG 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 002 NDA LYRICA PREGABALIN CAPSULE;ORAL 50MG Prescription Yes No AB 2004/12/30 UPJOHN
091219 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 TEVA PHARMS
203459 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 ALEMBIC
208677 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 SCIEGEN PHARMS INC
209357 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 MSN
209664 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 DR REDDYS
209743 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 AMNEAL PHARMS CO
210432 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 RISING
211384 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/07/19 INVAGEN PHARMS
207799 008 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/09/30 ALKEM LABS LTD
206912 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/10/08 HETERO LABS LTD III
091157 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Discontinued No No AB 2019/11/29 SUN PHARM
210585 001 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2019/12/26 RENATA
212280 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2020/01/10 CIPLA
212865 001 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2020/03/20 CHARTWELL RX
213423 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2020/03/23 CREEKWOOD PHARMS
091025 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2020/07/09 ACTAVIS ELIZABETH
211685 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2021/07/07 APOTEX
214322 001 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2021/07/15 CHANGZHOU PHARM
212988 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2022/03/08 ESKAYEF
091040 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Discontinued No No AB 2022/05/03 LUPIN LTD
216197 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2022/07/18 ADAPTIS
207883 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2022/09/01 PRINSTON INC
206752 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Discontinued No No AB 2022/12/09 ZYDUS PHARMS
205321 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2023/03/29 AUROBINDO PHARMA
215755 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2023/04/26 ACI
206452 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Discontinued No No AB 2023/07/12 CADILA PHARMS LTD
209883 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 50MG Prescription No No AB 2024/01/24 STRIDES PHARMA
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:100MG 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 004 NDA LYRICA PREGABALIN CAPSULE;ORAL 100MG Prescription Yes No AB 2004/12/30 UPJOHN
091224 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 TEVA PHARMS
203459 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 ALEMBIC
208677 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 SCIEGEN PHARMS INC
209357 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 MSN
209664 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 DR REDDYS
209743 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 AMNEAL PHARMS CO
207799 002 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
210432 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 RISING
211384 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/07/19 INVAGEN PHARMS
206912 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/10/08 HETERO LABS LTD III
091157 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Discontinued No No AB 2019/11/29 SUN PHARM
210585 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2019/12/26 RENATA
212280 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2020/01/10 CIPLA
212865 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2020/03/20 CHARTWELL RX
213423 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2020/03/23 CREEKWOOD PHARMS
091025 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2020/07/09 ACTAVIS ELIZABETH
211685 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2021/07/07 APOTEX
214322 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2021/07/15 CHANGZHOU PHARM
212988 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2022/03/08 ESKAYEF
091040 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Discontinued No No AB 2022/05/03 LUPIN LTD
216197 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2022/07/18 ADAPTIS
207883 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2022/09/01 PRINSTON INC
206752 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Discontinued No No AB 2022/12/09 ZYDUS PHARMS
205321 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2023/03/29 AUROBINDO PHARMA
215755 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2023/04/26 ACI
206452 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Discontinued No No AB 2023/07/12 CADILA PHARMS LTD
209883 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 100MG Prescription No No AB 2024/01/24 STRIDES PHARMA
活性成分:PREGABALIN 剂型/给药途径:CAPSULE;ORAL 规格:150MG 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 005 NDA LYRICA PREGABALIN CAPSULE;ORAL 150MG Prescription Yes No AB 2004/12/30 UPJOHN
091224 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 TEVA PHARMS
203459 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 ALEMBIC
208677 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 SCIEGEN PHARMS INC
209357 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 MSN
209664 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 DR REDDYS
209743 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 AMNEAL PHARMS CO
207799 003 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 ALKEM LABS LTD
210432 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 RISING
211384 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/07/19 INVAGEN PHARMS
206912 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/10/08 HETERO LABS LTD III
091157 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Discontinued No No AB 2019/11/29 SUN PHARM
210585 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2019/12/26 RENATA
212280 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2020/01/10 CIPLA
212865 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2020/03/20 CHARTWELL RX
213423 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2020/03/23 CREEKWOOD PHARMS
091025 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2020/07/09 ACTAVIS ELIZABETH
211685 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2021/07/07 APOTEX
214322 004 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2021/07/15 CHANGZHOU PHARM
212988 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2022/03/08 ESKAYEF
091040 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Discontinued No No AB 2022/05/03 LUPIN LTD
216197 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2022/07/18 ADAPTIS
207883 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2022/09/01 PRINSTON INC
206752 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Discontinued No No AB 2022/12/09 ZYDUS PHARMS
205321 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2023/03/29 AUROBINDO PHARMA
215755 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2023/04/26 ACI
206452 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Discontinued No No AB 2023/07/12 CADILA PHARMS LTD
209883 005 ANDA PREGABALIN PREGABALIN CAPSULE;ORAL 150MG Prescription No No AB 2024/01/24 STRIDES PHARMA
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