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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DAPSONE | 086841 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | Yes | No | 1979/07/03 | Approved Prior to Jan 1, 1982 | EVEREST LIFE SCI | Prescription |
DAPSONE | 086842 | 001 | ANDA | DAPSONE | TABLET;ORAL | 100MG | Yes | No | 1979/07/03 | Approved Prior to Jan 1, 1982 | EVEREST LIFE SCI | Prescription |
DAPSONE | 205429 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2016/01/07 | 2016/01/07 | ALVOGEN | Discontinued |
DAPSONE | 205429 | 002 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | No | 2016/01/07 | 2016/01/07 | ALVOGEN | Discontinued |
DAPSONE | 203887 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2016/05/06 | 2016/05/06 | NOSTRUM LABS INC | Prescription |
DAPSONE | 203887 | 002 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | No | 2016/05/06 | 2016/05/06 | NOSTRUM LABS INC | Prescription |
DAPSONE | 204074 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2016/05/10 | 2016/05/10 | CHARTWELL RX | Discontinued |
DAPSONE | 204074 | 002 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | No | 2016/05/10 | 2016/05/10 | CHARTWELL RX | Discontinued |
DAPSONE | 206505 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2016/12/01 | 2016/12/01 | NOVITIUM PHARMA | Prescription |
DAPSONE | 206505 | 002 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | Yes | 2016/12/01 | 2016/12/01 | NOVITIUM PHARMA | Prescription |
DAPSONE | 204380 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2017/03/23 | 2017/03/23 | ACTAVIS LLC | Prescription |
DAPSONE | 204380 | 002 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | No | 2017/03/23 | 2017/03/23 | ACTAVIS LLC | Prescription |
DAPSONE | 209506 | 001 | ANDA | DAPSONE | GEL;TOPICAL | 5% | No | No | 2017/10/16 | 2017/10/16 | TARO | Prescription |
DAPSONE | 209430 | 001 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2019/03/01 | 2019/03/01 | TARO | Discontinued |
DAPSONE | 209430 | 002 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | No | 2019/03/01 | 2019/03/01 | TARO | Discontinued |
DAPSONE | 207165 | 001 | ANDA | DAPSONE | TABLET;ORAL | 100MG | No | No | 2019/05/08 | 2019/05/08 | RISING | Prescription |
DAPSONE | 207165 | 002 | ANDA | DAPSONE | TABLET;ORAL | 25MG | No | No | 2019/05/08 | 2023/07/20 | RISING | Prescription |
DAPSONE | 210191 | 001 | ANDA | DAPSONE | GEL;TOPICAL | 7.5% | No | No | 2019/06/26 | 2019/06/26 | TARO | Prescription |
DAPSONE | 213847 | 001 | ANDA | DAPSONE | GEL;TOPICAL | 7.5% | No | No | 2022/02/04 | 2022/02/04 | MYLAN | Prescription |
DAPSONE | 214722 | 001 | ANDA | DAPSONE | GEL;TOPICAL | 7.5% | No | No | 2022/02/10 | 2022/02/10 | TORRENT | Prescription |