FDA.reportPublic FDA data

Application 022512

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRADAXADABIGATRAN ETEXILATE MESYLATECAPSULE;ORALEQ 75MG BASEYesNo
002PRADAXADABIGATRAN ETEXILATE MESYLATECAPSULE;ORALEQ 150MG BASEYesYes
003PRADAXADABIGATRAN ETEXILATE MESYLATECAPSULE;ORALEQ 110MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0108Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0135Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0135Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0149Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0355Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0360Pradaxadabigatran etexilate mesylateBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
21695-899PRADAXAdabigatran etexilate mesylateRebel Distributors CorpNDACurrent
50090-3617Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-3617Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-3617Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-3617Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-4480Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-4480Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-4480Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-4480Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
50090-4480Pradaxadabigatran etexilate mesylateA-S Medication SolutionsNDACurrent
63629-8242Pradaxadabigatran etexilate mesylateBryant Ranch PrepackNDACurrent
63629-8242Pradaxadabigatran etexilate mesylateBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83206SUPPL 2025-10-03
82606SUPPL 2025-10-03
83097SUPPL 2025-08-13
82607SUPPL 2025-06-20
76640SUPPL 2024-01-12
76636SUPPL 2023-11-20
67870SUPPL2021-06-23
67849SUPPL2021-06-22
67848SUPPL2021-06-22
67154SUPPL2021-04-22
67133SUPPL2021-04-22
63791SUPPL2020-07-06
63782SUPPL2020-07-02
63781SUPPL2020-07-02
61052SUPPL2019-11-26
61044SUPPL2019-11-25
61043SUPPL2019-11-25
52983SUPPL2018-03-15
52977SUPPL2018-03-15
38798SUPPL2015-11-25
7486SUPPL2015-11-23
38799SUPPL2015-10-27
7487SUPPL2015-10-26
17667SUPPL2015-09-21
7485SUPPL2015-09-14
38797SUPPL2015-09-11
29813SUPPL2015-08-28
38795SUPPL2015-01-20
7483SUPPL2015-01-20
38796SUPPL2014-09-26
7484SUPPL2014-09-08
38794SUPPL2014-08-15
7482SUPPL2014-08-15
29812SUPPL2014-04-09
38792SUPPL2014-04-08
7481SUPPL2013-12-13
38793SUPPL2013-12-11
22043SUPPL2013-06-04
29811SUPPL2013-04-30
38791SUPPL2013-04-29
42544SUPPL2013-04-10
23407ORIG2013-01-03
29810SUPPL2012-12-26
38790SUPPL2012-12-21
38789SUPPL2012-11-06
7480SUPPL2012-11-06
17666SUPPL2012-06-11
29809SUPPL2012-06-05
29808SUPPL2012-05-02
17665SUPPL2012-05-01
38788SUPPL2012-01-23
29807SUPPL2012-01-19
7479SUPPL2011-11-14
38787SUPPL2011-11-10
7478SUPPL2011-04-07
44186ORIG2011-03-29
29806SUPPL2011-03-08
38786SUPPL2011-03-07
24328ORIG2011-02-17
22042ORIG2010-11-30
29805ORIG2010-10-20
17664ORIG2010-10-20