药品注册申请号：216276
申请类型：ANDA (仿制药申请)
申请人：AMNEAL
申请人全名：AMNEAL EU 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 THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG No No AB 2023/03/20 2023/03/20 Prescription
002 THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG No No AB 2023/03/20 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
2023/03/20 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:THEOPHYLLINE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
087400 002 ANDA THEOCHRON THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 1983/01/11 NOSTRUM PHARMS LLC
089763 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 1990/04/30 HERITAGE PHARMA AVET
090430 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2010/10/27 ALEMBIC
212184 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2021/06/03 GLENMARK PHARMS LTD
216961 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2022/10/12 TEVA PHARMS INC
214950 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/01/30 VELZEN PHARMA PVT
216276 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/03/20 AMNEAL
216300 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/04/26 BIONPHARMA
214113 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/05/11 RHODES PHARMS
217422 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/09/08 ANNORA PHARMA
214806 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2023/10/24 HARMAN FINOCHEM
218063 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2024/05/21 ZYDUS LIFESCIENCES
215312 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2024/09/05 STRIDES PHARMA
活性成分:THEOPHYLLINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:450MG 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
081236 001 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 1992/11/09 HERITAGE PHARMA AVET
090430 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No Yes AB 2010/10/27 ALEMBIC
212184 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2021/06/03 GLENMARK PHARMS LTD
216961 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2022/10/12 TEVA PHARMS INC
214950 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2023/01/30 VELZEN PHARMA PVT
216276 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2023/03/20 AMNEAL
216300 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2023/04/26 BIONPHARMA
087400 005 ANDA THEOCHRON THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2023/08/09 NOSTRUM PHARMS LLC
217422 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2023/09/08 ANNORA PHARMA
214806 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2023/10/24 HARMAN FINOCHEM
218063 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2024/05/21 ZYDUS LIFESCIENCES
215312 002 ANDA THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 450MG Prescription No No AB 2024/09/05 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
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