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 |
|---|
| 2019/08/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/10/30 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:AMMONIA N-13 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:30mCi-300mCi/8ML (3.75-37.5mCi/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 |
|---|
| 022119 |
001 |
NDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
Yes |
Yes |
AP |
2007/08/23
|
FEINSTEIN |
| 203321 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2013/02/25
|
MCPRF |
| 203700 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2013/02/25
|
CARDINAL HLTH 414 |
| 203812 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2013/06/27
|
UCLA BIOMEDICAL |
| 203938 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2013/12/09
|
KREITCHMAN PET CTR |
| 204506 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2014/02/07
|
WA UNIV SCH MED |
| 204496 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2014/03/28
|
UCSF RODIOPHARM |
| 204514 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2014/08/19
|
JOHNS HOPKINS UNIV |
| 204465 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2014/10/23
|
DECATUR |
| 203783 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2014/10/30
|
BRIGHAM WOMENS HOSP |
| 204535 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2014/11/20
|
MIPS CRF |
| 204455 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2015/04/23
|
NUKEMED |
| 203779 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2015/10/19
|
3D IMAGING DRUG |
| 204457 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2015/11/18
|
MIDWEST MEDCL |
| 207025 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2016/02/03
|
GEN HOSP |
| 209507 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2019/11/01
|
UNIV TX SW MEDCTR |
| 211740 |
001 |
ANDA |
AMMONIA N 13 |
AMMONIA N-13 |
INJECTABLE;INTRAVENOUS |
30mCi-300mCi/8ML (3.75-37.5mCi/ML) |
Prescription |
No |
No |
AP |
2020/09/09
|
UNIV WISCONSIN |