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 | 205245 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2015/09/23 | 2015/09/23 | APPCO | Prescription |
METRONIDAZOLE | 207309 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2016/05/16 | 2016/05/16 | FLAMINGO PHARMS | Discontinued |
METRONIDAZOLE | 207309 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2016/05/16 | 2016/05/16 | FLAMINGO PHARMS | Discontinued |
METRONIDAZOLE | 208162 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2016/05/25 | 2016/05/25 | ESJAY PHARMA | Prescription |
METRONIDAZOLE | 208162 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2016/05/25 | 2016/05/25 | ESJAY PHARMA | Prescription |
METRONIDAZOLE | 206560 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2016/11/16 | 2016/11/16 | CADILA | Prescription |
METRONIDAZOLE | 206560 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2016/11/16 | 2016/11/16 | CADILA | Prescription |
METRONIDAZOLE | 204651 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 1% | No | No | 2017/03/14 | 2017/03/14 | TARO | Prescription |
METRONIDAZOLE IN PLASTIC CONTAINER | 205531 | 001 | ANDA | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No | 2017/05/09 | 2017/05/09 | RISING | Discontinued |
METRONIDAZOLE | 208681 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2017/06/20 | 2017/06/20 | ALEMBIC | Prescription |
METRONIDAZOLE | 208681 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2017/06/20 | 2017/06/20 | ALEMBIC | Prescription |
METRONIDAZOLE | 209096 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2017/09/12 | 2017/09/12 | LUPIN LTD | Prescription |
METRONIDAZOLE | 209096 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2017/09/12 | 2017/09/12 | LUPIN LTD | Prescription |
METRONIDAZOLE | 209794 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2017/12/12 | 2017/12/12 | CADILA PHARMS LTD | Prescription |
METRONIDAZOLE | 209794 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2017/12/12 | 2017/12/12 | CADILA PHARMS LTD | Prescription |
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | 202584 | 001 | ANDA | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG | No | Yes | 2018/11/30 | 2018/11/30 | AILEX PHARMS LLC | Prescription |
METRONIDAZOLE IN PLASTIC CONTAINER | 206191 | 001 | ANDA | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No | 2019/02/25 | 2019/02/25 | INFORLIFE | Prescription |
METRONIDAZOLE | 211786 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 0.75% | No | No | 2019/07/02 | 2019/07/02 | PADAGIS ISRAEL | Prescription |
METRONIDAZOLE IN PLASTIC CONTAINER | 212435 | 001 | ANDA | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No | 2020/08/03 | 2020/08/03 | GLAND PHARMA LTD | Prescription |
METRONIDAZOLE | 212646 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 1% | No | No | 2021/09/03 | 2021/09/03 | ALEMBIC | Prescription |