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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
XYOSTED (AUTOINJECTOR) | 209863 | 001 | NDA | TESTOSTERONE ENANTHATE | SOLUTION;SUBCUTANEOUS | 50MG/0.5ML (50MG/0.5ML) | Yes | Yes | 2018/09/28 | 2018/09/28 | ANTARES PHARMA INC | Prescription |
XYOSTED (AUTOINJECTOR) | 209863 | 002 | NDA | TESTOSTERONE ENANTHATE | SOLUTION;SUBCUTANEOUS | 75MG/0.5ML (75MG/0.5ML) | Yes | Yes | 2018/09/28 | 2018/09/28 | ANTARES PHARMA INC | Prescription |
XYOSTED (AUTOINJECTOR) | 209863 | 003 | NDA | TESTOSTERONE ENANTHATE | SOLUTION;SUBCUTANEOUS | 100MG/0.5ML (100MG/0.5ML) | Yes | Yes | 2018/09/28 | 2018/09/28 | ANTARES PHARMA INC | Prescription |