| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MONISTAT 3 | 018888 | 001 | NDA | MICONAZOLE NITRATE | SUPPOSITORY;VAGINAL | 200MG | Yes | Yes | 1984/08/15 | 1984/08/15 | MEDTECH PRODUCTS | Prescription |
| MONISTAT 3 COMBINATION PACK | 020670 | 002 | NDA | MICONAZOLE NITRATE | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 2%,200MG | Yes | Yes | 1996/04/16 | 1996/04/16 | MEDTECH PRODUCTS | Over-the-counter |
| MONISTAT 3 | 020827 | 001 | NDA | MICONAZOLE NITRATE | CREAM;VAGINAL | 4% | Yes | Yes | 1998/03/30 | 1998/03/30 | MEDTECH PRODUCTS | Over-the-counter |
| MONISTAT 3 COMBINATION PACK (PREFILLED) | 021261 | 001 | NDA | MICONAZOLE NITRATE | CREAM;TOPICAL, VAGINAL | 2%,4% | Yes | Yes | 2001/02/02 | 2001/02/02 | MEDTECH PRODUCTS | Over-the-counter |
| MONISTAT 3 COMBINATION PACK | 021261 | 003 | NDA | MICONAZOLE NITRATE | CREAM;TOPICAL, VAGINAL | 2%,4% | Yes | No | 2001/02/02 | 2003/06/17 | MEDTECH PRODUCTS | Over-the-counter |