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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SODIUM PHENYLBUTYRATE | 090910 | 001 | ANDA | SODIUM PHENYLBUTYRATE | TABLET;ORAL | 500MG | No | No | 2011/11/18 | 2011/11/18 | ALVOGEN | Discontinued |
SODIUM PHENYLBUTYRATE | 202819 | 001 | ANDA | SODIUM PHENYLBUTYRATE | POWDER;ORAL | 3GM/TEASPOONFUL | No | No | 2013/03/22 | 2013/03/22 | SIGMAPHARM LABS LLC | Prescription |
SODIUM PHENYLBUTYRATE | 204395 | 001 | ANDA | SODIUM PHENYLBUTYRATE | TABLET;ORAL | 500MG | No | No | 2016/04/15 | 2016/04/15 | ENDO OPERATIONS | Prescription |
SODIUM PHENYLBUTYRATE | 203918 | 001 | ANDA | SODIUM PHENYLBUTYRATE | POWDER;ORAL | 3GM/TEASPOONFUL | No | No | 2016/06/15 | 2016/06/15 | ENDO OPERATIONS | Prescription |
SODIUM PHENYLBUTYRATE | 216462 | 001 | ANDA | SODIUM PHENYLBUTYRATE | TABLET;ORAL | 500MG | No | No | 2022/11/01 | 2022/11/01 | GLENMARK PHARMS LTD | Prescription |