| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MONTELUKAST SODIUM | 203795 | 001 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No | 2015/02/27 | 2015/02/27 | JUBILANT GENERICS | Discontinued |
| MONTELUKAST SODIUM | 203795 | 002 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No | 2015/02/27 | 2015/02/27 | JUBILANT GENERICS | Discontinued |
| MONTELUKAST SODIUM | 203582 | 001 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No | 2015/03/12 | 2015/03/12 | MACLEODS PHARMS LTD | Prescription |
| MONTELUKAST SODIUM | 203582 | 002 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No | 2015/03/12 | 2015/03/12 | MACLEODS PHARMS LTD | Prescription |
| MONTELUKAST SODIUM | 204093 | 001 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No | 2015/05/22 | 2015/05/22 | HETERO LABS LTD V | Prescription |
| MONTELUKAST SODIUM | 204093 | 002 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No | 2015/05/22 | 2015/05/22 | HETERO LABS LTD V | Prescription |
| MONTELUKAST SODIUM | 203328 | 001 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No | 2015/07/31 | 2015/07/31 | AJANTA PHARMA LTD | Discontinued |
| MONTELUKAST SODIUM | 203328 | 002 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No | 2015/07/31 | 2015/07/31 | AJANTA PHARMA LTD | Discontinued |
| MONTELUKAST SODIUM | 203432 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2015/07/31 | 2015/07/31 | AJANTA PHARMA LTD | Discontinued |
| MONTELUKAST SODIUM | 203438 | 001 | ANDA | MONTELUKAST SODIUM | GRANULE;ORAL | EQ 4MG BASE/PACKET | No | No | 2015/07/31 | 2015/07/31 | AJANTA PHARMA LTD | Prescription |
| MONTELUKAST SODIUM | 204604 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2015/09/04 | 2015/09/04 | AMNEAL PHARMS | Prescription |
| MONTELUKAST SODIUM | 204290 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2015/10/08 | 2015/10/08 | UNICHEM | Prescription |
| MONTELUKAST SODIUM | 205695 | 001 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No | 2015/11/05 | 2015/11/05 | ANBISON LAB | Prescription |
| MONTELUKAST SODIUM | 205695 | 002 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No | 2015/11/05 | 2015/11/05 | ANBISON LAB | Prescription |
| MONTELUKAST SODIUM | 205683 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2016/01/12 | 2016/01/12 | ANBISON LAB | Prescription |
| MONTELUKAST SODIUM | 207463 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2016/10/28 | 2016/10/28 | CIPLA | Prescription |
| MONTELUKAST SODIUM | 209011 | 001 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No | 2017/04/18 | 2017/04/18 | RISING | Prescription |
| MONTELUKAST SODIUM | 209011 | 002 | ANDA | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No | 2017/04/18 | 2017/04/18 | RISING | Prescription |
| MONTELUKAST SODIUM | 209012 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2017/04/24 | 2017/04/24 | GRAVITI PHARMS | Prescription |
| MONTELUKAST SODIUM | 206112 | 001 | ANDA | MONTELUKAST SODIUM | TABLET;ORAL | EQ 10MG BASE | No | No | 2017/04/26 | 2017/04/26 | L PERRIGO CO | Discontinued |