药品注册申请号：217411
申请类型：ANDA (仿制药申请)
申请人：RISING
申请人全名：RISING PHARMA HOLDINGS 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 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2023/05/19 2023/05/19 Prescription
002 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG No No AB 2023/05/19 Prescription
003 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG No No AB 2023/05/19 Prescription
004 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG No No AB 2023/05/19 Prescription
005 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG No No AB 2023/05/19 Prescription
006 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG No No AB 2023/05/19 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
2023/05/19 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:AMITRIPTYLINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
085968 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
089399 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1987/07/14 SUN PHARM INDS INC
040218 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 1997/09/11 VINTAGE PHARMS
202446 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/06/04 ACCORD HLTHCARE
210086 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2017/10/06 ZYDUS PHARMS
213999 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/02/19 MANKIND PHARMA
214548 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/05/19 UNICHEM
212654 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/09/29 AIPING PHARM INC
216243 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2022/06/06 CHEMISTRY HLTH
215376 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/05/01 RUBICON
217411 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2023/05/19 RISING
活性成分:AMITRIPTYLINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
085968 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 SANDOZ
089399 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 1987/07/14 SUN PHARM INDS INC
040218 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AB 1997/09/11 VINTAGE PHARMS
202446 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2014/06/04 ACCORD HLTHCARE
210086 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2017/10/06 ZYDUS PHARMS
212654 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2020/04/07 AIPING PHARM INC
213999 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/02/19 MANKIND PHARMA
214548 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2021/05/19 UNICHEM
216243 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2022/06/06 CHEMISTRY HLTH
215376 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2023/05/01 RUBICON
217411 002 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2023/05/19 RISING
活性成分:AMITRIPTYLINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
089400 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB -- MUTUAL PHARM
085968 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
089399 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 1987/07/14 SUN PHARM INDS INC
040218 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued No No AB 1997/09/11 VINTAGE PHARMS
202446 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2014/06/04 ACCORD HLTHCARE
210086 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2017/10/06 ZYDUS PHARMS
213999 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/02/19 MANKIND PHARMA
214548 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/05/19 UNICHEM
212654 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2021/09/29 AIPING PHARM INC
216243 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2022/06/06 CHEMISTRY HLTH
215376 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2023/05/01 RUBICON
217411 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2023/05/19 RISING
活性成分:AMITRIPTYLINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
085968 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
089399 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 1987/07/14 SUN PHARM INDS INC
040218 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Discontinued No No AB 1997/09/11 VINTAGE PHARMS
202446 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2014/06/04 ACCORD HLTHCARE
210086 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2017/10/06 ZYDUS PHARMS
213999 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2021/02/19 MANKIND PHARMA
214548 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2021/05/19 UNICHEM
212654 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2021/09/29 AIPING PHARM INC
216243 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2022/06/06 CHEMISTRY HLTH
215376 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2023/05/01 RUBICON
217411 004 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 75MG Prescription No No AB 2023/05/19 RISING
活性成分:AMITRIPTYLINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
089402 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB -- MUTUAL PHARM
085968 003 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
089399 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1987/07/14 SUN PHARM INDS INC
040218 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Discontinued No No AB 1997/09/11 VINTAGE PHARMS
202446 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2014/06/04 ACCORD HLTHCARE
210086 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/10/06 ZYDUS PHARMS
213999 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/02/19 MANKIND PHARMA
214548 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/05/19 UNICHEM
212654 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/09/29 AIPING PHARM INC
216243 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2022/06/06 CHEMISTRY HLTH
215376 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2023/05/01 RUBICON
217411 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2023/05/19 RISING
活性成分:AMITRIPTYLINE HYDROCHLORIDE 剂型/给药途径:TABLET;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
085970 001 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB -- SANDOZ
085968 005 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
089399 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 1987/07/14 SUN PHARM INDS INC
040218 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Discontinued No No AB 1997/09/11 VINTAGE PHARMS
202446 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2014/06/04 ACCORD HLTHCARE
210086 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2017/10/06 ZYDUS PHARMS
213999 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2021/02/19 MANKIND PHARMA
214548 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2021/05/19 UNICHEM
212654 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2021/09/29 AIPING PHARM INC
216243 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2022/06/06 CHEMISTRY HLTH
215376 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2023/05/01 RUBICON
217411 006 ANDA AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET;ORAL 150MG Prescription No No AB 2023/05/19 RISING
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