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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TAVIST-1 | 017661 | 002 | NDA | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG | No | No | 1977/02/25 | Approved Prior to Jan 1, 1982 | NOVARTIS | Discontinued |
TAVIST-1 | 017661 | 003 | NDA | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG | No | No | 1977/02/25 | 1992/08/21 | NOVARTIS | Discontinued |
TAVIST-1 | 020925 | 001 | NDA | CLEMASTINE FUMARATE | TABLET;ORAL | 1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1992/08/21 | 1992/08/21 | HALEON US HOLDINGS | Discontinued |