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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DITROPAN XL | 020897 | 001 | NDA | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | Yes | No | 1998/12/16 | 1998/12/16 | JANSSEN PHARMS | Discontinued |
DITROPAN XL | 020897 | 002 | NDA | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | Yes | No | 1998/12/16 | 1998/12/16 | JANSSEN PHARMS | Discontinued |
DITROPAN XL | 020897 | 003 | NDA | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1998/12/16 | 1999/06/22 | JANSSEN PHARMS | Discontinued |