批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2016/12/08 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:FLUDEOXYGLUCOSE F-18 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:20-300mCi/ML 治疗等效代码:AP
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 203246 |
002 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/01/13
|
UNIV TX MD ANDERSON |
| 203935 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/02/05
|
WUSM CYCLOTRON |
| 203946 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Discontinued |
No |
No |
AP |
2014/02/05
|
ESSENTIAL ISOTOPES |
| 203902 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/05/09
|
UCSF RODIOPHARM |
| 203990 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/08/06
|
UIHC PET IMAGING |
| 204333 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/09/25
|
MA GENERAL HOSP |
| 204463 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/10/21
|
DECATUR |
| 204385 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/10/29
|
CHILDRENS HOSP MI |
| 204525 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/10/29
|
ISOLOGIC INNOVATIVE |
| 203816 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/10/30
|
BRIGHAM WOMENS |
| 204264 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2014/12/18
|
PHARMALOGIC |
| 204512 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/01/07
|
NCM USA BRONX LLC |
| 203904 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/04/23
|
METHODIST HOSP RES |
| 203837 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/05/01
|
BIOMEDCL RES FDN |
| 203710 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/05/01
|
BIOMEDCL RES FDN |
| 203920 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/06/23
|
JUBILANT DRAXIMAGE |
| 204498 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/06/23
|
UNIV UTAH CYCLOTRON |
| 204531 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/07/17
|
UNIV MICHIGAN |
| 203591 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/08/31
|
SOFIE |
| 204472 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/09/11
|
MIPS CRF |
| 203778 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/10/30
|
3D IMAGING DRUG |
| 203603 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2015/11/13
|
CARDINAL HEALTH 414 |
| 208679 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2016/12/08
|
MEM SLOAN-KETTERING |
| 209341 |
001 |
ANDA |
FLUDEOXYGLUCOSE F18 |
FLUDEOXYGLUCOSE F-18 |
INJECTABLE;INTRAVENOUS |
20-300mCi/ML |
Prescription |
No |
No |
AP |
2020/12/16
|
UNIV SOUTHERN CA |