药品注册申请号：209829
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA 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 TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No AB;AB 2023/03/14 2023/03/13 Prescription
002 TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No AB;AB 2026/06/05 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2026/06/05 ORIG-2（原始申请） Approval STANDARD
2023/03/14 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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
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与本品治疗等效的药品
>>>活性成分:TOFACITINIB CITRATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 5MG BASE; 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
203214 001 NDA XELJANZ TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 2012/11/06 PF PRISM CV
209738 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/03/13 MICRO LABS
209829 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/03/13 ZYDUS PHARMS
215356 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 AUROBINDO PHARMA LTD
209633 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 BRECKENRIDGE
217299 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 MSN
218096 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 APOTEX
219395 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 SPECGX LLC
219530 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 MACLEODS PHARMS LTD
220137 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 SOMERSET THERAPS LLC
218821 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/09 CONCORD BIOTECH LTD
215552 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/09 YAOPHARMA CO LTD
>>>活性成分:TOFACITINIB CITRATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 5MG BASE; 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
203214 001 NDA XELJANZ TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription Yes No AB 2012/11/06 PF PRISM CV
209738 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/03/13 MICRO LABS
209829 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2023/03/13 ZYDUS PHARMS
215356 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 AUROBINDO PHARMA LTD
209633 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 BRECKENRIDGE
217299 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 MSN
218096 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 APOTEX
219395 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 SPECGX LLC
219530 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 MACLEODS PHARMS LTD
220137 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/03 SOMERSET THERAPS LLC
218821 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/09 CONCORD BIOTECH LTD
215552 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE Prescription No No AB 2026/06/09 YAOPHARMA CO LTD
>>>活性成分:TOFACITINIB CITRATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 10MG BASE; 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
203214 002 NDA XELJANZ TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB 2018/05/30 PF PRISM CV
212943 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/06/01 AJANTA PHARMA LTD
215356 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 AUROBINDO PHARMA LTD
217299 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 MSN
218096 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 APOTEX
209633 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 BRECKENRIDGE
209738 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 MICRO LABS
219395 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 SPECGX LLC
219530 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 MACLEODS PHARMS LTD
220137 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 SOMERSET THERAPS LLC
209829 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/05 ZYDUS PHARMS
218821 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/09 CONCORD BIOTECH LTD
215552 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/09 YAOPHARMA CO LTD
>>>活性成分:TOFACITINIB CITRATE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 10MG BASE; 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
203214 002 NDA XELJANZ TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB 2018/05/30 PF PRISM CV
212943 001 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2021/06/01 AJANTA PHARMA LTD
215356 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 AUROBINDO PHARMA LTD
217299 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 MSN
218096 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 APOTEX
209633 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 BRECKENRIDGE
209738 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 MICRO LABS
219395 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 SPECGX LLC
219530 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 MACLEODS PHARMS LTD
220137 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/03 SOMERSET THERAPS LLC
209829 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/05 ZYDUS PHARMS
218821 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/09 CONCORD BIOTECH LTD
215552 002 ANDA TOFACITINIB CITRATE TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2026/06/09 YAOPHARMA CO LTD
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