| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LIMBITROL | 016949 | 001 | NDA | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | TABLET;ORAL | EQ 12.5MG BASE;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/12/23 | Approved Prior to Jan 1, 1982 | CHARTWELL RX | Discontinued |
| LIMBITROL DS | 016949 | 002 | NDA | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | TABLET;ORAL | EQ 25MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1977/12/23 | Approved Prior to Jan 1, 1982 | CHARTWELL RX | Discontinued |