| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FLUDEOXYGLUCOSE F18 | 204385 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/10/29 | 2014/10/29 | CHILDRENS HOSP MI | Prescription |
| FLUDEOXYGLUCOSE F18 | 204525 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/10/29 | 2014/10/29 | ISOLOGIC INNOVATIVE | Prescription |
| FLUDEOXYGLUCOSE F18 | 203816 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/10/30 | 2014/10/30 | BRIGHAM WOMENS | Prescription |
| FLUDEOXYGLUCOSE F18 | 203937 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 4-500mCi/ML | No | No | 2014/10/30 | 2014/10/30 | HOT SHOTS NM LLC | Discontinued |
| FLUDEOXYGLUCOSE F18 | 204264 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/12/18 | 2014/12/18 | PHARMALOGIC | Prescription |
| FLUDEOXYGLUCOSE F18 | 204512 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/01/07 | 2015/01/07 | NCM USA BRONX LLC | Prescription |
| FLUDEOXYGLUCOSE F18 | 203994 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 4-500mCi/ML | No | No | 2015/02/04 | 2015/02/04 | NORTHLAND | Prescription |
| FLUDEOXYGLUCOSE F18 | 204546 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | No | No | 2015/04/07 | 2015/04/07 | PRECISION NUCLEAR | Prescription |
| FLUDEOXYGLUCOSE F18 | 203911 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 4-500mCi/ML | No | No | 2015/04/22 | 2015/04/22 | NUKEMED | Prescription |
| FLUDEOXYGLUCOSE F18 | 203904 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/04/23 | 2015/04/23 | METHODIST HOSP RES | Prescription |
| FLUDEOXYGLUCOSE F18 | 203710 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/05/01 | 2015/05/01 | BIOMEDCL RES FDN | Prescription |
| FLUDEOXYGLUCOSE F18 | 203837 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/05/01 | 2015/05/01 | BIOMEDCL RES FDN | Prescription |
| FLUDEOXYGLUCOSE F18 | 203920 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/06/23 | 2015/06/23 | JUBILANT DRAXIMAGE | Prescription |
| FLUDEOXYGLUCOSE F18 | 204498 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/06/23 | 2015/06/23 | UNIV UTAH CYCLOTRON | Prescription |
| FLUDEOXYGLUCOSE F18 | 204531 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/07/17 | 2015/07/17 | UNIV MICHIGAN | Prescription |
| FLUDEOXYGLUCOSE F18 | 203591 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/08/31 | 2015/08/31 | SOFIE | Prescription |
| FLUDEOXYGLUCOSE F18 | 203771 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 10-100mCi/ML | No | Yes | 2015/08/31 | 2015/08/31 | QUEEN HAMAMATSU PET | Prescription |
| FLUDEOXYGLUCOSE F18 | 204472 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/09/11 | 2015/09/11 | MIPS CRF | Prescription |
| FLUDEOXYGLUCOSE F18 | 204759 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 4-40mCi/ML | No | No | 2015/10/27 | 2015/10/27 | KETTERING MEDCTR | Prescription |
| FLUDEOXYGLUCOSE F18 | 203778 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/10/30 | 2015/10/30 | 3D IMAGING DRUG | Prescription |