PRADAXA |
022512 |
001 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
CAPSULE;ORAL |
EQ 75MG BASE |
Yes
|
No
|
2010/10/19
|
2010/10/19
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
022512 |
002 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
CAPSULE;ORAL |
EQ 150MG BASE |
Yes
|
Yes
|
2010/10/19
|
2010/10/19
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
022512 |
003 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
CAPSULE;ORAL |
EQ 110MG BASE |
Yes
|
No
|
2010/10/19
|
2015/11/20
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
214358 |
001 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
PELLETS;ORAL |
EQ 20MG BASE/PACKET |
Yes
|
No
|
2021/06/21
|
2021/06/21
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
214358 |
002 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
PELLETS;ORAL |
EQ 30MG BASE/PACKET |
Yes
|
No
|
2021/06/21
|
2021/06/21
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
214358 |
003 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
PELLETS;ORAL |
EQ 40MG BASE/PACKET |
Yes
|
No
|
2021/06/21
|
2021/06/21
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
214358 |
004 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
PELLETS;ORAL |
EQ 50MG BASE/PACKET |
Yes
|
No
|
2021/06/21
|
2021/06/21
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
214358 |
005 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
PELLETS;ORAL |
EQ 110MG BASE/PACKET |
Yes
|
No
|
2021/06/21
|
2021/06/21
|
BOEHRINGER INGELHEIM |
Prescription |
PRADAXA |
214358 |
006 |
NDA |
DABIGATRAN ETEXILATE MESYLATE |
PELLETS;ORAL |
EQ 150MG BASE/PACKET |
Yes
|
Yes
|
2021/06/21
|
2021/06/21
|
BOEHRINGER INGELHEIM |
Prescription |