美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=RIVAROXABAN"
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
RIVAROXABAN 208549 001 ANDA RIVAROXABAN TABLET;ORAL 10MG No No 2019/05/16 (TA) -- PRINSTON INC None (Tentative Approval)
RIVAROXABAN 208549 002 ANDA RIVAROXABAN TABLET;ORAL 15MG No No 2019/05/16 (TA) -- PRINSTON INC None (Tentative Approval)
RIVAROXABAN 208549 003 ANDA RIVAROXABAN TABLET;ORAL 20MG No No 2019/05/16 (TA) -- PRINSTON INC None (Tentative Approval)
RIVAROXABAN 212220 001 ANDA RIVAROXABAN TABLET;ORAL 2.5MG No No 2022/06/27 (TA) -- MYLAN PHARMS INC None (Tentative Approval)
RIVAROXABAN 210301 001 ANDA RIVAROXABAN TABLET;ORAL 2.5MG No No 2023/10/17 (TA) -- ALEMBIC PHARMS LTD None (Tentative Approval)
RIVAROXABAN 208557 002 ANDA RIVAROXABAN TABLET;ORAL 10MG No No 2023/11/03 (TA) -- TARO PHARM INDS LTD None (Tentative Approval)
RIVAROXABAN 208555 001 ANDA RIVAROXABAN INJECTABLE;INJECTION 0.2% No No 2024/01/22 (TA) -- LUPIN LTD None (Tentative Approval)
RIVAROXABAN 208555 002 ANDA RIVAROXABAN INJECTABLE;INJECTION 0.5% No No 2024/01/22 (TA) -- LUPIN LTD None (Tentative Approval)
RIVAROXABAN 208555 003 ANDA RIVAROXABAN INJECTABLE;INJECTION 1% No No 2024/01/22 (TA) -- LUPIN LTD None (Tentative Approval)
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