| 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 PHENYLACETATE AND SODIUM BENZOATE | 207096 | 001 | ANDA | SODIUM BENZOATE; SODIUM PHENYLACETATE | SOLUTION;INTRAVENOUS | 10%;10% (5GM/50ML;5GM/50ML) | No | Yes | 2016/02/24 | 2016/02/24 | AILEX PHARMS LLC | Prescription |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 205880 | 001 | ANDA | SODIUM BENZOATE; SODIUM PHENYLACETATE | SOLUTION;INTRAVENOUS | 10%;10% (5GM/50ML;5GM/50ML) | No | No | 2016/08/04 | 2016/08/04 | NAVINTA LLC | Prescription |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 208521 | 001 | ANDA | SODIUM BENZOATE; SODIUM PHENYLACETATE | SOLUTION;INTRAVENOUS | 10%;10% (5GM/50ML;5GM/50ML) | No | No | 2017/05/08 | 2017/05/08 | MAIA PHARMS INC | Prescription |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 215025 | 001 | NDA | SODIUM BENZOATE; SODIUM PHENYLACETATE | SOLUTION;INTRAVENOUS | 10%;10% (2GM/20ML;2GM/20ML) | Yes | Yes | 2021/06/10 | 2021/06/10 | MAIA PHARMS INC | Prescription |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | 217526 | 001 | ANDA | SODIUM BENZOATE; SODIUM PHENYLACETATE | SOLUTION;INTRAVENOUS | 10%;10% (2GM/20ML; 2GM/20ML) | No | No | 2023/07/14 | 2023/07/14 | NAVINTA LLC | Prescription |
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