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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DRIZALMA SPRINKLE | 212516 | 001 | NDA | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | Yes | No | 2019/07/19 | 2019/07/19 | SUN PHARM | Prescription |
DRIZALMA SPRINKLE | 212516 | 002 | NDA | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | Yes | No | 2019/07/19 | 2019/07/19 | SUN PHARM | Prescription |
DRIZALMA SPRINKLE | 212516 | 003 | NDA | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | Yes | No | 2019/07/19 | 2019/07/19 | SUN PHARM | Prescription |
DRIZALMA SPRINKLE | 212516 | 004 | NDA | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | Yes | Yes | 2019/07/19 | 2019/07/19 | SUN PHARM | Prescription |