FDA.reportPublic FDA data

Application 020850

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICARDISTELMISARTANTABLET;ORAL40MGYesNo
002MICARDISTELMISARTANTABLET;ORAL80MGYesYes
003MICARDISTELMISARTANTABLET;ORAL20MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0542TelmisartantelmisartanWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0542TelmisartantelmisartanWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0543TelmisartantelmisartanWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0543TelmisartantelmisartanWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0544TelmisartantelmisartanWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0544TelmisartantelmisartanWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0597-0039MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0039MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0039MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0039MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0040MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0040MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0040MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0040MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0041MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0041MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0041MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0041MicardistelmisartanBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72984SUPPL2022-12-21
72975SUPPL2022-12-21
52298SUPPL2018-02-02
52262SUPPL2018-02-02
35513SUPPL2014-12-15
26059SUPPL2014-12-15
13618SUPPL2012-10-26
3578SUPPL2012-10-26
35512SUPPL2012-09-24
26057SUPPL2012-09-24
35510SUPPL2012-01-23
26058SUPPL2012-01-23
13617SUPPL2012-01-23
3576SUPPL2012-01-23
44076ORIG2011-12-22
35511SUPPL2011-07-12
3577SUPPL2011-07-07
26056SUPPL2009-11-20
26055SUPPL2009-11-19
3575SUPPL2009-11-19
13616SUPPL2009-10-21
13615SUPPL2009-09-17
13614SUPPL2009-09-17
3574SUPPL2007-03-06
26054SUPPL2005-09-08
13613SUPPL2005-09-08
35509SUPPL2004-05-06
26053SUPPL2004-04-07
26052SUPPL2003-10-31
41760ORIG2001-08-06
35508ORIG1998-11-10
3573ORIG1998-11-10