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 | 203603 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2015/11/13 | 2015/11/13 | CARDINAL HEALTH 414 | Prescription |
FLUDEOXYGLUCOSE F18 | 203603 | 002 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-500mCi/ML | No | Yes | 2015/11/13 | 2018/09/27 | CARDINAL HEALTH 414 | Prescription |
FLUDEOXYGLUCOSE F18 | 203736 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML | No | No | 2015/11/19 | 2015/11/19 | MIDWEST MEDCL | Discontinued |
FLUDEOXYGLUCOSE F18 | 203942 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 10-100mCi/ML | No | No | 2016/04/11 | 2016/04/11 | KREITCHMAN PET CTR | Prescription |
FLUDEOXYGLUCOSE F18 | 208679 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2016/12/08 | 2016/12/08 | MEM SLOAN-KETTERING | Prescription |
FLUDEOXYGLUCOSE F18 | 210265 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-200mCi/ML | No | No | 2020/02/06 | 2020/02/06 | UNIV TX SW MEDCTR | Discontinued |
FLUDEOXYGLUCOSE F18 | 209341 | 001 | ANDA | FLUDEOXYGLUCOSE F-18 | INJECTABLE;INTRAVENOUS | 20-300mCi/ML | No | No | 2020/12/16 | 2020/12/16 | UNIV SOUTHERN CA | Prescription |