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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TIROSINT-SOL | 206977 | 001 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 13MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 002 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 25MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 003 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 50MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 004 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 75MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 005 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 88MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 006 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 100MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 007 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 112MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 008 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 125MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 009 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 137MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 010 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 150MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 011 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 175MCG/ML | Yes | No | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 012 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 200MCG/ML | Yes | Yes | 2016/12/15 | 2016/12/15 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 013 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 37.5MCG/ML | Yes | No | 2016/12/15 | 2021/01/13 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 014 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 44MCG/ML | Yes | No | 2016/12/15 | 2021/01/13 | IBSA | Prescription |
TIROSINT-SOL | 206977 | 015 | NDA | LEVOTHYROXINE SODIUM | SOLUTION;ORAL | 62.5MCG/ML | Yes | No | 2016/12/15 | 2021/01/13 | IBSA | Prescription |