| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| KETALAR | 016812 | 001 | NDA | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | Yes | Yes | 1970/02/19 | Approved Prior to Jan 1, 1982 | ENDO OPERATIONS | Prescription |
| KETALAR | 016812 | 002 | NDA | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 50MG BASE/ML | Yes | No | 1970/02/19 | Approved Prior to Jan 1, 1982 | ENDO OPERATIONS | Prescription |
| KETALAR | 016812 | 003 | NDA | KETAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 100MG BASE/ML | Yes | No | 1970/02/19 | Approved Prior to Jan 1, 1982 | ENDO OPERATIONS | Prescription |