| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | 213648 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 0.75% | No | No | 2021/10/14 | 2021/10/14 | SOLARIS PHARMA CORP | Prescription |
| METRONIDAZOLE | 215794 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 0.75% | No | No | 2022/01/27 | 2022/01/27 | GLENMARK PHARMS LTD | Prescription |
| METRONIDAZOLE | 216692 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 1% | No | No | 2023/01/23 | 2023/01/23 | COSETTE | Prescription |
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | 205770 | 001 | ANDA | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | 140MG;125MG;125MG | No | No | 2023/03/06 | 2023/03/06 | ENDO OPERATIONS | Prescription |
| METRONIDAZOLE | 217128 | 001 | ANDA | METRONIDAZOLE | CREAM;TOPICAL | 0.75% | No | No | 2023/04/21 | 2023/04/21 | ZYDUS LIFESCIENCES | Prescription |
| METRONIDAZOLE IN PLASTIC CONTAINER | 217665 | 001 | ANDA | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No | 2023/05/24 | 2023/05/24 | AMNEAL | Prescription |
| METRONIDAZOLE | 215610 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 0.75% | No | No | 2023/06/16 | 2023/06/16 | ENCUBE | Prescription |
| BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | 217511 | 001 | ANDA | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | CAPSULE;ORAL | 140MG;125MG;125MG | No | No | 2023/07/03 | 2023/07/03 | NOVAST LABS | Prescription |
| METRONIDAZOLE | 216323 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 0.75% | No | No | 2023/07/12 | 2023/07/12 | COSETTE | Prescription |
| METRONIDAZOLE | 216795 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 1.3% | No | No | 2024/03/18 | 2024/03/18 | ENCUBE | Prescription |
| METRONIDAZOLE | 218941 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 1% | No | No | 2024/10/15 | 2024/10/15 | AUROBINDO PHARMA LTD | Prescription |