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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
GYNE-LOTRIMIN | 017717 | 002 | NDA | CLOTRIMAZOLE | TABLET;VAGINAL | 100MG | Yes | No | 1976/03/24 | 1990/11/30 | BAYER HEALTHCARE LLC | Discontinued |
GYNE-LOTRIMIN | 018052 | 002 | NDA | CLOTRIMAZOLE | CREAM;VAGINAL | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1978/11/08 | 1990/11/30 | BAYER HEALTHCARE LLC | Discontinued |
GYNE-LOTRIMIN COMBINATION PACK | 020289 | 002 | NDA | CLOTRIMAZOLE | CREAM, TABLET;TOPICAL, VAGINAL | 1%,100MG | Yes | No | 1993/04/26 | 1993/04/26 | BAYER HEALTHCARE LLC | Discontinued |
GYNE-LOTRIMIN 3 | 020525 | 001 | NDA | CLOTRIMAZOLE | TABLET;VAGINAL | 200MG | Yes | No | 1996/07/29 | 1996/07/29 | BAYER HEALTHCARE LLC | Discontinued |
GYNE-LOTRIMIN 3 COMBINATION PACK | 020526 | 002 | NDA | CLOTRIMAZOLE | CREAM, TABLET;TOPICAL, VAGINAL | 1%,200MG | Yes | No | 1996/07/29 | 1996/07/29 | BAYER HEALTHCARE LLC | Discontinued |
GYNE-LOTRIMIN 3 | 020574 | 001 | NDA | CLOTRIMAZOLE | CREAM;VAGINAL | 2% | Yes | No | 1998/11/24 | 1998/11/24 | BAYER HEALTHCARE LLC | Discontinued |