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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
GABAPENTIN | 090007 | 002 | ANDA | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No | 2011/07/21 | 2011/07/21 | MARKSANS PHARMA | Prescription |
GABAPENTIN | 090007 | 003 | ANDA | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No | 2011/07/21 | 2011/07/21 | MARKSANS PHARMA | Prescription |
GABAPENTIN | 200651 | 001 | ANDA | GABAPENTIN | TABLET;ORAL | 600MG | No | No | 2011/10/06 | 2011/10/06 | AUROBINDO PHARMA LTD | Prescription |
GABAPENTIN | 200651 | 002 | ANDA | GABAPENTIN | TABLET;ORAL | 800MG | No | No | 2011/10/06 | 2011/10/06 | AUROBINDO PHARMA LTD | Prescription |
GABAPENTIN | 202024 | 001 | ANDA | GABAPENTIN | SOLUTION;ORAL | 250MG/5ML | No | No | 2012/03/23 | 2012/03/23 | AMNEAL PHARMS | Prescription |
GABAPENTIN | 076403 | 001 | ANDA | GABAPENTIN | SOLUTION;ORAL | 250MG/5ML | No | No | 2012/05/01 | 2012/05/01 | ACELLA PHARMS LLC | Prescription |
GABAPENTIN | 202764 | 001 | ANDA | GABAPENTIN | TABLET;ORAL | 600MG | No | No | 2012/10/16 | 2012/10/16 | INVAGEN PHARMS | Discontinued |
GABAPENTIN | 202764 | 002 | ANDA | GABAPENTIN | TABLET;ORAL | 800MG | No | No | 2012/10/16 | 2012/10/16 | INVAGEN PHARMS | Discontinued |
GABAPENTIN | 076672 | 001 | ANDA | GABAPENTIN | SOLUTION;ORAL | 250MG/5ML | No | No | 2013/07/03 | 2013/07/03 | TARO | Prescription |
GABAPENTIN | 203244 | 001 | ANDA | GABAPENTIN | TABLET;ORAL | 800MG | No | No | 2013/07/12 | 2013/07/12 | STRIDES PHARMA | Prescription |
GABAPENTIN | 203244 | 002 | ANDA | GABAPENTIN | TABLET;ORAL | 600MG | No | No | 2013/07/12 | 2013/07/12 | STRIDES PHARMA | Prescription |
GABAPENTIN | 077261 | 001 | ANDA | GABAPENTIN | CAPSULE;ORAL | 100MG | No | No | 2013/08/02 | 2013/08/02 | TARO | Prescription |
GABAPENTIN | 077261 | 002 | ANDA | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No | 2013/08/02 | 2013/08/02 | TARO | Prescription |
GABAPENTIN | 077261 | 003 | ANDA | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No | 2013/08/02 | 2013/08/02 | TARO | Prescription |
GABAPENTIN | 203611 | 001 | ANDA | GABAPENTIN | TABLET; ORAL | 300MG | No | No | 2013/12/19 (TA) | -- | ACTAVIS ELIZABETH | None (Tentative Approval) |
GABAPENTIN | 203611 | 002 | ANDA | GABAPENTIN | TABLET; ORAL | 600MG | No | No | 2013/12/19 (TA) | -- | ACTAVIS ELIZABETH | None (Tentative Approval) |
GABAPENTIN | 206402 | 001 | ANDA | GABAPENTIN | TABLET;ORAL | 600MG | No | No | 2015/12/23 | 2015/12/23 | ALKEM LABS LTD | Prescription |
GABAPENTIN | 206402 | 002 | ANDA | GABAPENTIN | TABLET;ORAL | 800MG | No | No | 2015/12/23 | 2015/12/23 | ALKEM LABS LTD | Prescription |
GABAPENTIN | 205101 | 001 | ANDA | GABAPENTIN | TABLET;ORAL | 600MG | No | No | 2016/02/04 | 2016/02/04 | SCIEGEN PHARMS INC | Prescription |
GABAPENTIN | 205101 | 002 | ANDA | GABAPENTIN | TABLET;ORAL | 800MG | No | No | 2016/02/04 | 2016/02/04 | SCIEGEN PHARMS INC | Prescription |