美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=LEFLUNOMIDE"
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
LEFLUNOMIDE 077083 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2005/09/13 2005/09/13 BARR Discontinued
LEFLUNOMIDE 077083 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2005/09/13 2005/09/13 BARR Discontinued
LEFLUNOMIDE 077084 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2005/09/13 2005/09/13 TEVA PHARMS Discontinued
LEFLUNOMIDE 077084 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2005/09/13 2005/09/13 TEVA PHARMS Discontinued
LEFLUNOMIDE 077085 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2005/09/13 2005/09/13 SANDOZ Discontinued
LEFLUNOMIDE 077085 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2005/09/13 2005/09/13 SANDOZ Discontinued
LEFLUNOMIDE 077086 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2005/09/13 2005/09/13 HERITAGE PHARMS Prescription
LEFLUNOMIDE 077086 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2005/09/13 2005/09/13 HERITAGE PHARMS Prescription
LEFLUNOMIDE 077087 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2005/09/13 2005/09/13 WANBANG BIOPHARMS Prescription
LEFLUNOMIDE 077087 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2005/09/13 2005/09/13 WANBANG BIOPHARMS Prescription
LEFLUNOMIDE 077090 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2005/09/13 2005/09/13 APOTEX INC Prescription
LEFLUNOMIDE 077090 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2005/09/13 2005/09/13 APOTEX INC Prescription
LEFLUNOMIDE 091369 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2011/11/21 2011/11/21 ALEMBIC PHARMS LTD Prescription
LEFLUNOMIDE 091369 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2011/11/21 2011/11/21 ALEMBIC PHARMS LTD Prescription
LEFLUNOMIDE 212308 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2019/04/24 2019/04/24 ZYDUS LIFESCIENCES Prescription
LEFLUNOMIDE 212308 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2019/04/24 2019/04/24 ZYDUS LIFESCIENCES Prescription
LEFLUNOMIDE 212453 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2019/06/03 2019/06/03 ABHAI LLC Prescription
LEFLUNOMIDE 212453 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2019/06/03 2019/06/03 ABHAI LLC Prescription
LEFLUNOMIDE 211863 001 ANDA LEFLUNOMIDE TABLET;ORAL 10MG No No 2020/02/04 2020/02/04 LUPIN LTD Prescription
LEFLUNOMIDE 211863 002 ANDA LEFLUNOMIDE TABLET;ORAL 20MG No No 2020/02/04 2020/02/04 LUPIN LTD Prescription
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