| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | 204062 | 003 | ANDA | IBUPROFEN | TABLET;ORAL | 800MG | No | No | 2018/09/10 | 2018/09/10 | SUNSHINE | Discontinued |
| IBUPROFEN | 210755 | 001 | ANDA | IBUPROFEN | SUSPENSION/DROPS;ORAL | 40MG/ML | No | No | 2018/09/26 | 2018/09/26 | GUARDIAN DRUG | Over-the-counter |
| IBUPROFEN | 210602 | 001 | ANDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No | 2018/11/23 | 2018/11/23 | ANNORA PHARMA | Over-the-counter |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | 210676 | 001 | ANDA | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | CAPSULE;ORAL | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | No | No | 2019/02/14 | 2019/02/14 | AUROBINDO PHARMA LTD | Over-the-counter |
| IBUPROFEN | 209076 | 001 | ANDA | IBUPROFEN | TABLET;ORAL | 200MG | No | No | 2020/01/06 | 2020/01/06 | ULTRATAB LABS INC | Discontinued |
| IBUPROFEN | 213794 | 001 | ANDA | IBUPROFEN | TABLET;ORAL | 400MG | No | No | 2020/05/08 | 2020/05/08 | AUROBINDO PHARMA LTD | Prescription |
| IBUPROFEN | 213794 | 002 | ANDA | IBUPROFEN | TABLET;ORAL | 600MG | No | No | 2020/05/08 | 2020/05/08 | AUROBINDO PHARMA LTD | Prescription |
| IBUPROFEN | 213794 | 003 | ANDA | IBUPROFEN | TABLET;ORAL | 800MG | No | No | 2020/05/08 | 2020/05/08 | AUROBINDO PHARMA LTD | Prescription |
| IBUPROFEN | 214003 | 001 | ANDA | IBUPROFEN | TABLET;ORAL | 200MG | No | No | 2020/10/19 | 2020/10/19 | YICHANG HUMANWELL | Discontinued |
| IBUPROFEN | 211666 | 001 | ANDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No | 2021/02/22 | 2021/02/22 | STRIDES PHARMA | Discontinued |
| 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 |
| IBUPROFEN | 214699 | 001 | ANDA | IBUPROFEN | TABLET;ORAL | 400MG | No | No | 2021/09/13 | 2021/09/13 | ALKEM LABS LTD | Prescription |
| IBUPROFEN | 214699 | 002 | ANDA | IBUPROFEN | TABLET;ORAL | 600MG | No | No | 2021/09/13 | 2021/09/13 | ALKEM LABS LTD | Prescription |
| IBUPROFEN | 214699 | 003 | ANDA | IBUPROFEN | TABLET;ORAL | 800MG | No | No | 2021/09/13 | 2021/09/13 | ALKEM LABS LTD | 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 |
| IBUPROFEN | 215318 | 001 | ANDA | IBUPROFEN | TABLET;ORAL | 400MG | No | No | 2022/03/30 | 2022/03/30 | YICHANG HUMANWELL | Prescription |
| IBUPROFEN | 215318 | 002 | ANDA | IBUPROFEN | TABLET;ORAL | 600MG | No | No | 2022/03/30 | 2022/03/30 | YICHANG HUMANWELL | Prescription |
| IBUPROFEN | 215318 | 003 | ANDA | IBUPROFEN | TABLET;ORAL | 800MG | No | No | 2022/03/30 | 2022/03/30 | YICHANG HUMANWELL | Prescription |
| IBUPROFEN | 215311 | 001 | ANDA | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No | 2022/05/27 | 2022/05/27 | STRIDES PHARMA | Prescription |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | 216204 | 001 | ANDA | DIPHENHYDRAMINE CITRATE; IBUPROFEN | TABLET;ORAL | 38MG;200MG | No | No | 2022/05/31 | 2022/05/31 | AUROBINDO PHARMA | Over-the-counter |