e-Drug3D
1499
cas 211915-06-9
CLASS
BLOOD
ANTITHROMBOTIC AGENTS
THROMBINE INHIBITOR
TO REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION
ROUTE (list)
ORAL
ATC code
B01AE07
PK parameters
Solubility
OF 1.8 MILLIGRAM / MILLILITER
TARGET PROTHROMBIN
Prothrombin UNIPROT P00734 F2
Formula:
C34H41N7O5
Calculated chemical properties:
MW 627.74
NB_atoms 46
XLogP 5.81
PSA 131.901
NB_HD 3
NB_HA 12
fsp3 0.35
Lipinski(0=no;1=yes) 0
NB_atoms 46
XLogP 5.81
PSA 131.901
NB_HD 3
NB_HA 12
fsp3 0.35
Lipinski(0=no;1=yes) 0
FDA
NDA 022512 (label) INN (DABIGATRAN ETEXILATE MESYLATE) PRADAXA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2010
NDA 208057 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2017
NDA 207984 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2020
NDA 207961 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020
NDA 208040 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020
NDA 214358 (label) INN (DABIGATRAN ETEXILATE MESYLATE) PRADAXA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2021
NDA 208046 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2022
NDA 208070 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (APOTEX) APPROVAL= AP YEAR= 2023
NDA 207922 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 213879 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (MSN) APPROVAL= AP YEAR= 2024
NDA 215233 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALEMBIC) APPROVAL= AP YEAR= 2024
NDA 208048 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (DR REDDYS) APPROVAL= AP YEAR= 2025
NDA 208067 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (MYLAN) APPROVAL= AP YEAR= 2025
NDA 208039 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2025
NDA 022512 (label) INN (DABIGATRAN ETEXILATE MESYLATE) PRADAXA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2010
NDA 208057 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (TEVA PHARMS USA) APPROVAL= TA YEAR= 2017
NDA 207984 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (GLENMARK PHARMS LTD) APPROVAL= TA YEAR= 2020
NDA 207961 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2020
NDA 208040 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2020
NDA 214358 (label) INN (DABIGATRAN ETEXILATE MESYLATE) PRADAXA (BOEHRINGER INGELHEIM) APPROVAL= AP YEAR= 2021
NDA 208046 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALEMBIC PHARMS LTD) APPROVAL= TA YEAR= 2022
NDA 208070 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (APOTEX) APPROVAL= AP YEAR= 2023
NDA 207922 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (BRECKENRIDGE) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 213879 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (MSN) APPROVAL= AP YEAR= 2024
NDA 215233 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (ALEMBIC) APPROVAL= AP YEAR= 2024
NDA 208048 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (DR REDDYS) APPROVAL= AP YEAR= 2025
NDA 208067 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (MYLAN) APPROVAL= AP YEAR= 2025
NDA 208039 (pdf not found) INN (DABIGATRAN ETEXILATE MESYLATE) DABIGATRAN ETEXILATE MESYLATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2025