美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=NILOTINIB"
符合检索条件的记录共 11 条
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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
NILOTINIB HYDROCHLORIDE 203640 001 ANDA NILOTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE No No 2024/01/05 2024/01/05 APOTEX Prescription
NILOTINIB HYDROCHLORIDE 203640 002 ANDA NILOTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE No No 2024/01/05 2024/01/05 APOTEX Prescription
NILOTINIB HYDROCHLORIDE 203640 003 ANDA NILOTINIB HYDROCHLORIDE CAPSULE;ORAL EQ 200MG BASE No No 2024/01/05 2024/01/05 APOTEX Prescription
NILOTINIB 218544 002 ANDA NILOTINIB CAPSULE;ORAL 150MG No No 2024/10/02 (TA) -- MSN LABORATORIES PRIVATE LTD None (Tentative Approval)
NILOTINIB 218544 003 ANDA NILOTINIB CAPSULE;ORAL 200MG No No 2024/10/02 (TA) -- MSN LABORATORIES PRIVATE LTD None (Tentative Approval)
NILOTINIB HYDROCHLORIDE DIHYDRATE 209651 001 ANDA NILOTINIB HYDROCHLORIDE DIHYDRATE CAPSULE 200MG No No 2024/12/10 (TA) -- HETERO LABS LIMITED None (Tentative Approval)
NILOTINIB HYDROCHLORIDE DIHYDRATE 209651 002 ANDA NILOTINIB HYDROCHLORIDE DIHYDRATE CAPSULE 50MG No No 2024/12/10 (TA) -- HETERO LABS LIMITED None (Tentative Approval)
NILOTINIB HYDROCHLORIDE DIHYDRATE 209651 003 ANDA NILOTINIB HYDROCHLORIDE DIHYDRATE CAPSULE 150MG No No 2024/12/10 (TA) -- HETERO LABS LIMITED None (Tentative Approval)
NILOTINIB D-TARTRATE 218922 001 NDA NILOTINIB D-TARTRATE CAPSULE;ORAL EQ 50MG BASE Yes No 2025/02/19 2025/02/19 CIPLA Prescription
NILOTINIB D-TARTRATE 218922 002 NDA NILOTINIB D-TARTRATE CAPSULE;ORAL EQ 150MG BASE Yes No 2025/02/19 2025/02/19 CIPLA Prescription
NILOTINIB D-TARTRATE 218922 003 NDA NILOTINIB D-TARTRATE CAPSULE;ORAL EQ 200MG BASE Yes Yes 2025/02/19 2025/02/19 CIPLA Prescription
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