| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NIZORAL | 070767 | 001 | ANDA | KETOCONAZOLE | SUSPENSION;ORAL | 100MG/5ML | No | No | -- | 1986/11/07 | JANSSEN PHARMA | Discontinued |
| NIZORAL | 018533 | 001 | NDA | KETOCONAZOLE | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1981/06/12 | Approved Prior to Jan 1, 1982 | JANSSEN PHARMS | Discontinued |
| NIZORAL | 019084 | 001 | NDA | KETOCONAZOLE | CREAM;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1985/12/31 | 1985/12/31 | JANSSEN PHARMA | Discontinued |
| NIZORAL | 019927 | 001 | NDA | KETOCONAZOLE | SHAMPOO;TOPICAL | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1990/08/31 | 1990/08/31 | JANSSEN PHARMS | Discontinued |
| NIZORAL ANTI-DANDRUFF | 020310 | 001 | NDA | KETOCONAZOLE | SHAMPOO;TOPICAL | 1% | Yes | Yes | 1997/10/10 | 1997/10/10 | KRAMER | Over-the-counter |