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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ARMODAFINIL | 200751 | 001 | ANDA | ARMODAFINIL | TABLET;ORAL | 50MG | No | No | 2016/11/28 | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 001 | ANDA | ARMODAFINIL | TABLET;ORAL | 50MG | No | No | 2016/11/28 (TA) | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 002 | ANDA | ARMODAFINIL | TABLET; ORAL | 100MG | No | No | 2016/11/28 | -- | LUPIN LTD | None (Tentative Approval) |
ARMODAFINIL | 200751 | 002 | ANDA | ARMODAFINIL | TABLET; ORAL | 100MG | No | No | 2016/11/28 (TA) | -- | LUPIN LTD | None (Tentative Approval) |
ARMODAFINIL | 200751 | 003 | ANDA | ARMODAFINIL | TABLET;ORAL | 150MG | No | No | 2016/11/28 | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 003 | ANDA | ARMODAFINIL | TABLET;ORAL | 150MG | No | No | 2016/11/28 (TA) | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 004 | ANDA | ARMODAFINIL | TABLET;ORAL | 200MG | No | No | 2016/11/28 | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 004 | ANDA | ARMODAFINIL | TABLET;ORAL | 200MG | No | No | 2016/11/28 (TA) | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 005 | ANDA | ARMODAFINIL | TABLET;ORAL | 250MG | No | No | 2016/11/28 | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 200751 | 005 | ANDA | ARMODAFINIL | TABLET;ORAL | 250MG | No | No | 2016/11/28 (TA) | 2016/11/28 | LUPIN LTD | Prescription |
ARMODAFINIL | 202768 | 001 | ANDA | ARMODAFINIL | TABLET;ORAL | 50MG | No | No | 2016/11/28 | 2016/11/28 | NATCO PHARMA LTD | Prescription |
ARMODAFINIL | 202768 | 002 | ANDA | ARMODAFINIL | TABLET;ORAL | 150MG | No | No | 2016/11/28 | 2016/11/28 | NATCO PHARMA LTD | Prescription |
ARMODAFINIL | 202768 | 003 | ANDA | ARMODAFINIL | TABLET;ORAL | 250MG | No | No | 2016/11/28 | 2016/11/28 | NATCO PHARMA LTD | Prescription |
ARMODAFINIL | 202768 | 004 | ANDA | ARMODAFINIL | TABLET;ORAL | 100MG | No | No | 2016/11/28 | 2017/09/28 | NATCO PHARMA LTD | Prescription |
ARMODAFINIL | 202768 | 005 | ANDA | ARMODAFINIL | TABLET;ORAL | 200MG | No | No | 2016/11/28 | 2017/09/28 | NATCO PHARMA LTD | Prescription |
ARMODAFINIL | 206069 | 001 | ANDA | ARMODAFINIL | TABLET;ORAL | 50MG | No | No | 2018/03/06 | 2018/03/06 | AUROBINDO PHARMA LTD | Prescription |
ARMODAFINIL | 206069 | 002 | ANDA | ARMODAFINIL | TABLET;ORAL | 150MG | No | No | 2018/03/06 | 2018/03/06 | AUROBINDO PHARMA LTD | Prescription |
ARMODAFINIL | 206069 | 003 | ANDA | ARMODAFINIL | TABLET;ORAL | 250MG | No | No | 2018/03/06 | 2018/03/06 | AUROBINDO PHARMA LTD | Prescription |
ARMODAFINIL | 206069 | 004 | ANDA | ARMODAFINIL | TABLET;ORAL | 200MG | No | No | 2018/03/06 | 2018/12/07 | AUROBINDO PHARMA LTD | Prescription |
ARMODAFINIL | 201514 | 001 | ANDA | ARMODAFINIL | TABLET;ORAL | 50MG | No | No | 2019/03/25 | 2019/03/25 | COREPHARMA | Discontinued |