| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TAPAZOLE | 007517 | 002 | NDA | METHIMAZOLE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1950/06/21 | Approved Prior to Jan 1, 1982 | KING PHARMS | Discontinued |
| TAPAZOLE | 007517 | 004 | NDA | METHIMAZOLE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1950/06/21 | Approved Prior to Jan 1, 1982 | KING PHARMS | Discontinued |
| TAPAZOLE | 040320 | 001 | ANDA | METHIMAZOLE | TABLET;ORAL | 5MG | No | No | 2000/03/31 | 2000/03/31 | KING PHARMS LLC | Discontinued |
| TAPAZOLE | 040320 | 002 | ANDA | METHIMAZOLE | TABLET;ORAL | 10MG | No | No | 2000/03/31 | 2000/03/31 | KING PHARMS LLC | Discontinued |