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 | 076522 | 001 | ANDA | METRONIDAZOLE | CAPSULE;ORAL | 375MG | No | No | 2004/01/29 | 2004/01/29 | CHARTWELL RX | Prescription |
METRONIDAZOLE | 076408 | 001 | ANDA | METRONIDAZOLE | CREAM;TOPICAL | 0.75% | No | No | 2004/05/28 | 2004/05/28 | FOUGERA PHARMS | Prescription |
METRONIDAZOLE | 077197 | 001 | ANDA | METRONIDAZOLE | LOTION;TOPICAL | 0.75% | No | No | 2006/05/24 | 2006/05/24 | FOUGERA PHARMS | Prescription |
METRONIDAZOLE | 077018 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 0.75% | No | No | 2006/06/06 | 2006/06/06 | FOUGERA PHARMS | Prescription |
METRONIDAZOLE | 077547 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 0.75% | No | No | 2006/07/13 | 2006/07/13 | ENCUBE | Prescription |
METRONIDAZOLE | 077819 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 0.75% | No | No | 2006/07/18 | 2006/07/18 | TARO | Prescription |
METRONIDAZOLE | 077264 | 001 | ANDA | METRONIDAZOLE | GEL;VAGINAL | 0.75% | No | No | 2006/10/31 | 2006/10/31 | ENCUBE | Discontinued |
METRONIDAZOLE | 077549 | 001 | ANDA | METRONIDAZOLE | CREAM;TOPICAL | 0.75% | No | No | 2007/12/19 | 2007/12/19 | COSETTE | Prescription |
METRONIDAZOLE IN PLASTIC CONTAINER | 078084 | 001 | ANDA | METRONIDAZOLE | INJECTABLE;INJECTION | 500MG/100ML | No | No | 2008/03/31 | 2008/03/31 | BAXTER HLTHCARE CORP | Prescription |
METRONIDAZOLE | 079067 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2009/03/13 | 2009/03/13 | ALEMBIC PHARMS LTD | Prescription |
METRONIDAZOLE | 079067 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2009/03/13 | 2009/03/13 | ALEMBIC PHARMS LTD | Prescription |
METRONIDAZOLE | 079065 | 001 | ANDA | METRONIDAZOLE | CAPSULE;ORAL | 375MG | No | No | 2009/06/23 | 2009/06/23 | ALEMBIC | Prescription |
METRONIDAZOLE | 090222 | 001 | ANDA | METRONIDAZOLE | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No | 2010/05/05 | 2010/05/05 | ALEMBIC | Discontinued |
METRONIDAZOLE | 078178 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 0.75% | No | Yes | 2011/01/19 | 2011/01/19 | COSETTE | Prescription |
METRONIDAZOLE | 090903 | 001 | ANDA | METRONIDAZOLE | GEL;TOPICAL | 1% | No | No | 2011/07/22 | 2011/07/22 | CHARTWELL RX | Discontinued |
METRONIDAZOLE | 203458 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2014/01/22 | 2014/01/22 | UNICHEM | Prescription |
METRONIDAZOLE | 203458 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | No | 2014/01/22 | 2014/01/22 | UNICHEM | Prescription |
METRONIDAZOLE | 203974 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2015/05/29 | 2015/05/29 | AUROBINDO PHARMA LTD | Prescription |
METRONIDAZOLE | 203974 | 002 | ANDA | METRONIDAZOLE | TABLET;ORAL | 500MG | No | Yes | 2015/05/29 | 2015/05/29 | AUROBINDO PHARMA LTD | Prescription |
METRONIDAZOLE | 205245 | 001 | ANDA | METRONIDAZOLE | TABLET;ORAL | 250MG | No | No | 2015/09/23 | 2015/09/23 | APPCO | Prescription |