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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
PLAN B | 021045 | 001 | NDA | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/07/28 | 1999/07/28 | FDN CONSUMER | Discontinued |
PLAN B | 021045 | 002 | NDA | LEVONORGESTREL | TABLET;ORAL | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1999/07/28 | 2006/08/24 | FDN CONSUMER | Discontinued |
PLAN B ONE-STEP | 021998 | 001 | NDA | LEVONORGESTREL | TABLET;ORAL | 1.5MG | Yes | Yes | 2009/07/10 | 2009/07/10 | FDN CONSUMER | Over-the-counter |