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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CHOLINE C-11 | 203155 | 001 | NDA | CHOLINE C-11 | INJECTABLE;INTRAVENOUS | 4-33.1mCi/ML | Yes | Yes | 2012/09/12 | 2012/09/12 | MCPRF | Prescription |
CHOLINE C-11 | 205690 | 001 | ANDA | CHOLINE C-11 | INJECTABLE;INTRAVENOUS | 4-100mCi/ML | No | No | 2015/10/29 | 2015/10/29 | UNIV TX MD ANDERSON | Discontinued |
CHOLINE C-11 | 206319 | 001 | ANDA | CHOLINE C-11 | INJECTABLE;INTRAVENOUS | 4-33.1mCi/ML | No | No | 2015/11/13 | 2015/11/13 | DECATUR | Prescription |
CHOLINE C-11 | 208413 | 001 | ANDA | CHOLINE C-11 | INJECTABLE;INTRAVENOUS | 4-33.1mCi/ML | No | No | 2017/01/10 | 2017/01/10 | WA UNIV SCH MED | Discontinued |
CHOLINE C-11 | 208444 | 001 | ANDA | CHOLINE C-11 | INJECTABLE;INTRAVENOUS | 4-33.1mCi/ML | No | No | 2017/11/20 | 2017/11/20 | UCSF RODIOPHARM | Discontinued |