| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DULERA | 022518 | 001 | NDA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | AEROSOL, METERED;INHALATION | 0.005MG/INH;0.1MG/INH | Yes | Yes | 2010/06/22 | 2010/06/22 | ORGANON LLC | Prescription |
| DULERA | 022518 | 002 | NDA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | AEROSOL, METERED;INHALATION | 0.005MG/INH;0.2MG/INH | Yes | Yes | 2010/06/22 | 2010/06/22 | ORGANON LLC | Prescription |
| DULERA | 022518 | 003 | NDA | FORMOTEROL FUMARATE; MOMETASONE FUROATE | AEROSOL, METERED;INHALATION | 0.005MG/INH;0.05MG/INH | Yes | No | 2010/06/22 | 2019/08/12 | ORGANON LLC | Prescription |