| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| QUILLICHEW ER | 207960 | 001 | NDA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 20MG | Yes | No | 2015/12/04 | 2015/12/04 | NEXTWAVE PHARMS | Prescription |
| QUILLICHEW ER | 207960 | 002 | NDA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 30MG | Yes | No | 2015/12/04 | 2015/12/04 | NEXTWAVE PHARMS | Prescription |
| QUILLICHEW ER | 207960 | 003 | NDA | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE, CHEWABLE;ORAL | 40MG | Yes | Yes | 2015/12/04 | 2015/12/04 | NEXTWAVE PHARMS | Prescription |