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 219395 002 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No 2026/06/03 -- SPECGX LLC Prescription
TOFACITINIB CITRATE 219530 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No 2026/06/03 -- MACLEODS PHARMS LTD Prescription
TOFACITINIB CITRATE 219530 002 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No 2026/06/03 -- MACLEODS PHARMS LTD Prescription
TOFACITINIB CITRATE 220137 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No 2026/06/03 -- SOMERSET THERAPS LLC Prescription
TOFACITINIB CITRATE 220137 002 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No 2026/06/03 -- SOMERSET THERAPS LLC Prescription
TOFACITINIB CITRATE 220458 001 ANDA TOFACITINIB CITRATE TABLET, EXTENDED RELEASE;ORAL EQ 11MG BASE No No 2026/06/03 -- APOTEX Prescription
TOFACITINIB CITRATE 220458 001 ANDA TOFACITINIB CITRATE TABLET, EXTENDED RELEASE;ORAL EQ 11MG BASE No No 2026/06/03 (TA) -- APOTEX Prescription
TOFACITINIB CITRATE 209829 001 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 5MG BASE No No 2026/06/05 2023/03/13 ZYDUS PHARMS Prescription
TOFACITINIB CITRATE 209829 002 ANDA TOFACITINIB CITRATE TABLET;ORAL EQ 10MG BASE No No 2026/06/05 -- ZYDUS PHARMS Prescription
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