| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE | 206531 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2016/04/26 | 2016/04/26 | AUROBINDO PHARMA | Over-the-counter |
| FAMOTIDINE | 206531 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2016/04/26 | 2016/04/26 | AUROBINDO PHARMA | Over-the-counter |
| FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE | 204782 | 001 | ANDA | CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE | TABLET, CHEWABLE;ORAL | 800MG;10MG;165MG | No | No | 2016/08/29 | 2016/08/29 | PERRIGO R AND D | Discontinued |
| FAMOTIDINE | 215043 | 001 | ANDA | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | No | Yes | 2021/04/20 | 2021/04/20 | NOVITIUM PHARMA | Prescription |
| IBUPROFEN AND FAMOTIDINE | 211890 | 001 | ANDA | FAMOTIDINE; IBUPROFEN | TABLET;ORAL | 26.6MG;800MG | No | Yes | 2021/08/03 | 2021/08/03 | ALKEM LABS LTD | Prescription |
| FAMOTIDINE | 215689 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2021/10/15 | 2021/10/15 | ASCENT PHARMS INC | Prescription |
| FAMOTIDINE | 215689 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | No | 2021/10/15 | 2021/10/15 | ASCENT PHARMS INC | Prescription |
| IBUPROFEN AND FAMOTIDINE | 211278 | 001 | ANDA | FAMOTIDINE; IBUPROFEN | TABLET;ORAL | 26.6MG;800MG | No | No | 2021/10/29 | 2021/10/29 | TEVA PHARMS USA | Prescription |
| FAMOTIDINE | 216030 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2021/11/03 | 2021/11/03 | ASCENT PHARMS INC | Over-the-counter |
| FAMOTIDINE | 216030 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2021/11/03 | 2021/11/03 | ASCENT PHARMS INC | Over-the-counter |
| FAMOTIDINE | 215767 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2021/11/04 | 2021/11/04 | ANNORA PHARMA | Prescription |
| FAMOTIDINE | 215767 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | No | 2021/11/04 | 2021/11/04 | ANNORA PHARMA | Prescription |
| FAMOTIDINE | 215766 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2021/11/08 | 2021/11/08 | ANNORA PHARMA | Over-the-counter |
| FAMOTIDINE | 215766 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2021/11/08 | 2021/11/08 | ANNORA PHARMA | Over-the-counter |
| FAMOTIDINE | 215630 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2022/01/07 | 2022/01/07 | ALKEM LABS LTD | Prescription |
| FAMOTIDINE | 215630 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | No | 2022/01/07 | 2022/01/07 | ALKEM LABS LTD | Prescription |
| FAMOTIDINE | 215822 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 10MG | No | No | 2022/01/28 | 2022/01/28 | VKT PHARMA | Over-the-counter |
| FAMOTIDINE | 215822 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2022/01/28 | 2022/01/28 | VKT PHARMA | Over-the-counter |
| FAMOTIDINE | 216441 | 001 | ANDA | FAMOTIDINE | TABLET;ORAL | 20MG | No | No | 2022/06/03 | 2022/06/03 | ZYDUS PHARMS | Prescription |
| FAMOTIDINE | 216441 | 002 | ANDA | FAMOTIDINE | TABLET;ORAL | 40MG | No | No | 2022/06/03 | 2022/06/03 | ZYDUS PHARMS | Prescription |