| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | 215252 | 001 | NDA | DILTIAZEM HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2021/10/28 | 2021/10/28 | EXELA PHARMA | Discontinued |
| DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% | 215252 | 002 | NDA | DILTIAZEM HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2021/10/28 | 2021/10/28 | EXELA PHARMA | Discontinued |