| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PRIMAQUINE | 008316 | 001 | NDA | PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 15MG BASE | Yes | Yes | 1952/01/23 | Approved Prior to Jan 1, 1982 | SANOFI AVENTIS US | Prescription |
| ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE | 014860 | 002 | NDA | CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 300MG BASE;EQ 45MG BASE | No | No | 1968/12/09 | Approved Prior to Jan 1, 1982 | SANOFI AVENTIS US | Discontinued |
| PRIMAQUINE PHOSPHATE | 203924 | 001 | ANDA | PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 15MG BASE | No | No | 2014/02/03 | 2014/02/03 | ALVOGEN | Discontinued |
| PRIMAQUINE PHOSPHATE | 204476 | 001 | ANDA | PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 15MG BASE | No | No | 2014/02/25 | 2014/02/25 | BAYSHORE PHARMS LLC | Prescription |
| PRIMAQUINE PHOSPHATE | 206043 | 001 | ANDA | PRIMAQUINE PHOSPHATE | TABLET;ORAL | EQ 15MG BASE | No | No | 2016/06/23 | 2016/06/23 | NOVAST LABS | Prescription |