美国FDA药品数据库(U.S. FDA Drugs Database)
符合检索条件的记录共 19 条
共 1 页,当前第 1 页
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 |
IMBRUVICA |
205552 |
001 |
NDA |
IBRUTINIB |
CAPSULE;ORAL |
140MG |
Yes
|
Yes
|
2013/11/13
|
2013/11/13
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
205552 |
002 |
NDA |
IBRUTINIB |
CAPSULE;ORAL |
70MG |
Yes
|
No
|
2013/11/13
|
2017/12/20
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
205552 |
001 |
NDA |
IBRUTINIB |
CAPSULE;ORAL |
140MG |
Yes
|
Yes
|
2014/02/12
|
2013/11/13
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
205552 |
002 |
NDA |
IBRUTINIB |
CAPSULE;ORAL |
70MG |
Yes
|
No
|
2014/02/12
|
2017/12/20
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
001 |
NDA |
IBRUTINIB |
TABLET;ORAL |
140MG |
Yes
|
No
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
001 |
NDA |
IBRUTINIB |
TABLET;ORAL |
140MG |
Yes
|
No
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
002 |
NDA |
IBRUTINIB |
TABLET;ORAL |
280MG |
Yes
|
No
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
002 |
NDA |
IBRUTINIB |
TABLET;ORAL |
280MG |
Yes
|
No
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
003 |
NDA |
IBRUTINIB |
TABLET;ORAL |
420MG |
Yes
|
Yes
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
003 |
NDA |
IBRUTINIB |
TABLET;ORAL |
420MG |
Yes
|
Yes
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
210563 |
004 |
NDA |
IBRUTINIB |
TABLET;ORAL |
560MG |
Yes
|
No
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Discontinued |
IMBRUVICA |
210563 |
004 |
NDA |
IBRUTINIB |
TABLET;ORAL |
560MG |
Yes
|
No
|
2018/02/16
|
2018/02/16
|
PHARMACYCLICS LLC |
Discontinued |
IMBRUVICA |
217003 |
001 |
NDA |
IBRUTINIB |
SUSPENSION;ORAL |
70MG/ML |
Yes
|
Yes
|
2022/08/24
|
2022/08/24
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
217003 |
002 |
NDA |
IBRUTINIB |
CAPSULE;ORAL |
70MG |
No
|
No
|
2022/08/24
|
--
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
217003 |
003 |
NDA |
IBRUTINIB |
CAPSULE;ORAL |
140MG |
No
|
No
|
2022/08/24
|
--
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
217003 |
004 |
NDA |
IBRUTINIB |
TABLET;ORAL |
140MG |
No
|
No
|
2022/08/24
|
--
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
217003 |
005 |
NDA |
IBRUTINIB |
TABLET;ORAL |
230MG |
No
|
No
|
2022/08/24
|
--
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
217003 |
006 |
NDA |
IBRUTINIB |
TABLET;ORAL |
420MG |
No
|
No
|
2022/08/24
|
--
|
PHARMACYCLICS LLC |
Prescription |
IMBRUVICA |
217003 |
007 |
NDA |
IBRUTINIB |
TABLET;ORAL |
560MG |
No
|
No
|
2022/08/24
|
--
|
PHARMACYCLICS LLC |
Prescription |