| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE MAGNESIUM | 218948 | 003 | ANDA | ESOMEPRAZOLE MAGNESIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 40MG BASE/PACKET | No | No | 2025/04/15 | 2025/04/15 | AUROBINDO PHARMA LTD | Prescription |
| ESOMEPRAZOLE MAGNESIUM | 219213 | 001 | ANDA | ESOMEPRAZOLE MAGNESIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 10MG BASE/PACKET | No | No | 2025/04/15 | 2025/04/15 | AUROBINDO PHARMA LTD | Prescription |
| OMEPRAZOLE MAGNESIUM | 218829 | 001 | ANDA | OMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No | 2025/08/07 | 2025/08/07 | MARKSANS PHARMA | Over-the-counter |