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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
HIBICLENS | 017768 | 001 | NDA | CHLORHEXIDINE GLUCONATE | SOLUTION;TOPICAL | 4% | Yes | Yes | 1976/09/17 | Approved Prior to Jan 1, 1982 | MOLNLYCKE HLTH | Over-the-counter |
HIBICLENS | 018423 | 001 | NDA | CHLORHEXIDINE GLUCONATE | SPONGE;TOPICAL | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1981/08/27 | Approved Prior to Jan 1, 1982 | MOLNLYCKE HLTH | Discontinued |