| 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 | 020306 | 001 | NDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INJECTION | 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1994/08/19 | 1994/08/19 | DOWNSTATE CLINCL | Discontinued |
| FLUDEOXYGLUCOSE F18 | 020306 | 002 | NDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INJECTION | 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1994/08/19 | 2001/09/25 | DOWNSTATE CLINCL | Discontinued |
| FLUDEOXYGLUCOSE F18 | 021768 | 001 | NDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 10-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | No | No | 2004/08/05 | 2004/08/05 | WEILL MEDCL COLL | Discontinued |
| FLUDEOXYGLUCOSE F18 | 021870 | 001 | NDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 2005/08/19 | 2005/08/19 | FEINSTEIN | Discontinued |
| FLUDEOXYGLUCOSE F18 | 021870 | 002 | NDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-400mCi/ML | Yes | Yes | 2005/08/19 | 2008/11/21 | FEINSTEIN | Prescription |
| FLUDEOXYGLUCOSE F18 | 079086 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML | No | Yes | 2011/02/25 | 2011/02/25 | PETNET | Prescription |
| FLUDEOXYGLUCOSE F18 | 203665 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | No | No | 2013/02/14 | 2013/02/14 | SOFIE | Discontinued |
| FLUDEOXYGLUCOSE F18 | 203811 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 4-40mCi/ML | No | Yes | 2013/06/27 | 2013/06/27 | UCLA BIOMEDICAL | Prescription |
| FLUDEOXYGLUCOSE F18 | 203612 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-240mCi/ML | No | No | 2013/08/05 | 2013/08/05 | MCPRF | Prescription |
| FLUDEOXYGLUCOSE F18 | 203709 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | No | No | 2013/12/23 | 2013/10/23 | WISCONSIN | Prescription |
| FLUDEOXYGLUCOSE F18 | 203246 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-150mCi/ML | No | No | 2014/01/13 | 2014/01/13 | UNIV TX MD ANDERSON | Prescription |
| FLUDEOXYGLUCOSE F18 | 203246 | 002 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/01/13 | 2014/01/13 | UNIV TX MD ANDERSON | Prescription |
| FLUDEOXYGLUCOSE F18 | 203664 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML | No | No | 2014/02/04 | 2014/02/04 | PHARMALOGIC HLDGS | Prescription |
| FLUDEOXYGLUCOSE F18 | 203935 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/02/05 | 2014/02/05 | WUSM CYCLOTRON | Prescription |
| FLUDEOXYGLUCOSE F18 | 203946 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/02/05 | 2014/02/05 | ESSENTIAL ISOTOPES | Discontinued |
| FLUDEOXYGLUCOSE F18 | 203902 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/05/09 | 2014/05/09 | UCSF RODIOPHARM | Prescription |
| FLUDEOXYGLUCOSE F18 | 203990 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/08/06 | 2014/08/06 | UIHC PET IMAGING | Prescription |
| FLUDEOXYGLUCOSE F18 | 204333 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/09/25 | 2014/09/25 | MA GENERAL HOSP | Prescription |
| FLUDEOXYGLUCOSE F18 | 204463 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2014/10/21 | 2014/10/21 | DECATUR | Prescription |
| FLUDEOXYGLUCOSE F18 | 203801 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML | No | No | 2014/10/29 | 2014/10/29 | TRUSTEES UNIV PA | Prescription |