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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
ELIXOPHYLLIN | 085186 | 001 | ANDA | THEOPHYLLINE | SOLUTION, ELIXIR;ORAL | 80MG/15ML | Yes | Yes | 1979/01/26 | Approved Prior to Jan 1, 1982 | NOSTRUM LABS INC | Prescription |
ELIXOPHYLLIN | 083921 | 001 | ANDA | THEOPHYLLINE | CAPSULE;ORAL | 200MG | No | No | 1984/07/31 | 1984/07/31 | FOREST LABS | Discontinued |
ELIXOPHYLLIN SR | 086826 | 001 | ANDA | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 125MG | No | No | 1998/02/06 | 1985/01/29 | FOREST LABS | Discontinued |
ELIXOPHYLLIN SR | 086826 | 002 | ANDA | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 250MG | No | No | 1998/02/06 | 1985/01/29 | FOREST LABS | Discontinued |
ELIXOPHYLLIN | 085545 | 001 | ANDA | THEOPHYLLINE | CAPSULE;ORAL | 100MG | No | No | 1998/02/17 | 1984/07/31 | FOREST LABS | Discontinued |