| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HELIDAC | 050719 | 001 | NDA | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1996/08/15 | 1996/08/15 | CASPER PHARMA LLC | Discontinued |