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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TERAZOL 3 | 019641 | 001 | NDA | TERCONAZOLE | SUPPOSITORY;VAGINAL | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1988/05/24 | 1988/05/24 | JANSSEN PHARMS | Discontinued |
TERAZOL 3 | 019964 | 001 | NDA | TERCONAZOLE | CREAM;VAGINAL | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1991/02/21 | 1991/02/21 | JANSSEN PHARMS | Discontinued |