美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=TOFACITINIB"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
TOFACITINIB CITRATE 212943 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No 2021/06/01 2021/06/01 AJANTA PHARMA LTD Discontinued
TOFACITINIB CITRATE 212943 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No 2021/06/01 (TA) 2021/06/01 AJANTA PHARMA LTD Discontinued
TOFACITINIB 209633 001 ANDA TOFACITINIB TABLET;ORAL 5MG No No 2021/06/10 (TA) -- BRECKENRIDGE PHARMS None (Tentative Approval)
TOFACITINIB 214264 001 ANDA TOFACITINIB CITRATE TABLET, EXTENDED RELEASE;ORAL EQ 11MG BASE No No 2021/08/19 2021/08/19 ZYDUS PHARMS Discontinued
TOFACITINIB 214264 002 ANDA TOFACITINIB CITRATE TABLET, EXTENDED RELEASE;ORAL EQ 22MG BASE No No 2021/08/19 2021/08/19 ZYDUS PHARMS Discontinued
Tofacitinib 215552 001 ANDA Tofacitinib TABLET;ORAL 5MG No No 2022/10/04 (TA) -- YAOPHARMA CO LTD None (Tentative Approval)
Tofacitinib 215552 002 ANDA Tofacitinib TABLET;ORAL 10MG No No 2022/10/04 (TA) -- YAOPHARMA CO LTD None (Tentative Approval)
TOFACITINIB 217299 001 ANDA TOFACITINIB CITRATE TABLET;ORAL 5MG No No 2023/01/06 (TA) -- MSN PHARMS INC None (Tentative Approval)
TOFACITINIB 217299 002 ANDA TOFACITINIB CITRATE TABLET;ORAL 10MG No No 2023/01/06 (TA) -- MSN PHARMS INC None (Tentative Approval)
TOFACITINIB CITRATE 209738 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No 2023/03/13 2023/03/13 MICRO LABS Discontinued
TOFACITINIB CITRATE 209738 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No 2023/03/13 (TA) 2023/03/13 MICRO LABS Discontinued
TOFACITINIB CITRATE 209829 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No 2023/03/14 2023/03/13 ZYDUS PHARMS Discontinued
TOFACITINIB CITRATE 216878 001 ANDA TOFACITINIB CITRATE SOLUTION;ORAL EQ 1MG BASE/ML No No 2023/09/25 2023/09/25 HIKMA Discontinued
TOFACITINIB 209923 001 ANDA TOFACITINIB TABLET;ORAL 5MG No No 2024/04/09 (TA) -- PRINSTON PHARMA INC None (Tentative Approval)
TOFACITINIB 218462 001 ANDA TOFACITINIB CITRATE TABLET, EXTENDED RELEASE;ORAL EQ 11MG BASE No No 2024/06/03 2024/06/03 AUROBINDO PHARMA LTD Discontinued
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