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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
INTAL | 016990 | 001 | NDA | CROMOLYN SODIUM | CAPSULE;INHALATION | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | -- | Approved Prior to Jan 1, 1982 | SANOFI AVENTIS US | Discontinued |
INTAL | 018596 | 001 | NDA | CROMOLYN SODIUM | SOLUTION;INHALATION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1982/05/28 | 1982/05/28 | KING PHARMS LLC | Discontinued |
INTAL | 018887 | 001 | NDA | CROMOLYN SODIUM | AEROSOL, METERED;INHALATION | 0.8MG/INH | No | No | 1985/12/05 | 1985/12/05 | KING PHARMS LLC | Discontinued |