dabigatran etexilate Oral Capsule

Brand(s)
Pradaxa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-10-30)
Oldest Current Product
2010-10-26
License(s)
NDA
RxNORM
ORAL CAPSULE\DABIGATRAN ETEXILATE
FDAOB
ORAL\CAPSULE\DABIGATRAN ETEXILATE MESYLATE
SPL Active
ORAL\CAPSULE\DABIGATRAN ETEXILATE MESYLATE
SPL Moiety
ORAL\CAPSULE\DABIGATRAN
ORAL\CAPSULE\DABIGATRAN ETEXILATE

product(s) by strength(s)

dabigatran etexilate 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970135PradaxaNDABoehringer Ingelheim Pharmaceuticals, Inc.2010-10-26DABIGATRAN ETEXILATE MESYLATEORALCAPSULENDA022512ba74e3cd-b06f-4145-b284-5fd6b84ff3c9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950899PradaxaNDARebel Distributors Corp2010-10-26DABIGATRAN ETEXILATE MESYLATEORALCAPSULE005970135NDA0225125db7f199-8752-4d24-85f7-e34ca8f4d02e

dabigatran etexilate 75 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970149PradaxaNDABoehringer Ingelheim Pharmaceuticals, Inc.2011-08-08DABIGATRAN ETEXILATE MESYLATEORALCAPSULENDA022512ba74e3cd-b06f-4145-b284-5fd6b84ff3c9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022512PRADAXABOEHRINGER INGELHEIM PHARMACEUTICALS INC2010-10-19p7932273, SUBSTANCE
p6087380, INHIBITION OF THROMBIN, SUBSTANCE
p9034822, METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
p7866474, SUBSTANCE
NEW CHEMICAL ENTITY [2015-10-19]
TO REDUCE THE RISK OF RECURRENCE OF DVT AND PE IN PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED [2017-04-04]
TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR 5-10 DAYS [2017-04-04]
NDA022512_001, NDA022512_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022512_001RXDABIGATRAN ETEXILATE MESYLATE (EQ 75MG BASE)ORALCAPSULEFalse2010-10-19PRADAXA
2NDA022512_002RXDABIGATRAN ETEXILATE MESYLATE (EQ 150MG BASE)ORALCAPSULETrue2010-10-19PRADAXA

patent(s)

#idexpiration dateapplication(s)
1p6087380 (view patent)2018-02-18NDA022512
2p7866474 (view patent)2027-08-31NDA022512
3p7932273 (view patent)2025-09-07NDA022512
4p9034822 (view patent)2031-01-20NDA022512

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15db7f199-8752-4d24-85f7-e34ca8f4d02e (view SPL)These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA (dabigatran etexilate mesylate) capsules for oral use Initial U.S. Approval: 2010prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-231216950899
2ba74e3cd-b06f-4145-b284-5fd6b84ff3c9 (view SPL)These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA (dabigatran etexilate mesylate) capsules for oral useInitial U.S. Approval: 2010prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-10-3033005970135, 005970149

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII