| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RANEXA | 021526 | 001 | NDA | RANOLAZINE | TABLET, EXTENDED RELEASE;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2006/01/27 | 2007/02/12 | MENARINI INTL | Discontinued |
| RANEXA | 021526 | 002 | NDA | RANOLAZINE | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2006/01/27 | 2006/01/27 | MENARINI INTL | Discontinued |
| TRANEXAMIC ACID | 201885 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2011/08/10 | 2011/08/10 | AM REGENT | Prescription |
| TRANEXAMIC ACID | 091657 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2011/11/03 | 2011/11/03 | MYLAN INSTITUTIONAL | Prescription |
| TRANEXAMIC ACID | 202373 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2011/11/17 | 2011/11/17 | EPIC PHARMA LLC | Prescription |
| TRANEXAMIC ACID | 091596 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2012/03/02 | 2012/03/02 | FRESENIUS KABI USA | Prescription |
| TRANEXAMIC ACID | 202093 | 001 | ANDA | TRANEXAMIC ACID | TABLET;ORAL | 650MG | No | No | 2012/12/27 | 2012/12/27 | ACTAVIS LABS FL INC | Prescription |
| TRANEXAMIC ACID | 201580 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2013/06/14 | 2013/06/14 | XGEN PHARMS | Prescription |
| TRANEXAMIC ACID | 202286 | 001 | ANDA | TRANEXAMIC ACID | TABLET;ORAL | 650MG | No | No | 2014/01/27 | 2014/01/27 | APOTEX | Discontinued |
| TRANEXAMIC ACID | 202436 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2014/02/11 | 2014/02/11 | HERITAGE | Prescription |
| TRANEXAMIC ACID | 203521 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2014/08/12 | 2014/08/12 | AVET LIFESCIENCES | Prescription |
| TRANEXAMIC ACID | 205133 | 001 | ANDA | TRANEXAMIC ACID | TABLET;ORAL | 650MG | No | No | 2015/09/21 | 2015/09/21 | AUROBINDO PHARMA USA | Prescription |
| TRANEXAMIC ACID | 205035 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2016/01/14 | 2016/01/14 | EUGIA PHARMA | Prescription |
| TRANEXAMIC ACID | 202755 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2016/02/25 | 2016/02/25 | CHARTWELL RX | Discontinued |
| TRANEXAMIC ACID | 206634 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2016/06/09 | 2016/06/09 | RISING | Discontinued |
| TRANEXAMIC ACID | 203256 | 001 | ANDA | TRANEXAMIC ACID | TABLET;ORAL | 650MG | No | No | 2016/07/25 | 2016/07/25 | ANI PHARMS | Prescription |
| TRANEXAMIC ACID | 207239 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2017/02/13 | 2017/02/13 | GLAND | Prescription |
| TRANEXAMIC ACID | 208840 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2017/02/28 | 2017/02/28 | AMNEAL PHARMS CO | Prescription |
| TRANEXAMIC ACID | 206713 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2017/06/27 | 2017/06/27 | MICRO LABS | Prescription |
| TRANEXAMIC ACID | 205228 | 001 | ANDA | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No | 2017/07/17 | 2017/07/17 | ZYDUS PHARMS | Discontinued |