FDA.reportPublic FDA data

Application 021162

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;40MGYesNo
002MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;80MGYesNo
003MICARDIS HCTHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL25MG;80MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideHikma Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0545telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideHikma Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0054-0546telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideHikma Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0054-0547telmisartan and hydrochlorothiazidetelmisartan and hydrochlorothiazideWest-Ward Pharmaceuticals Corp.NDA AUTHORIZED GENERICCurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0042Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0043Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0044Micardis HCTtelmisartan and hydrochlorothiazideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72985SUPPL2022-12-21
72976SUPPL2022-12-21
64355SUPPL2020-08-21
64340SUPPL2020-08-21
52299SUPPL2018-02-02
52261SUPPL2018-02-02
36249SUPPL2016-01-25
26946SUPPL2016-01-14
36250SUPPL2014-12-16
26947SUPPL2014-12-15
14538SUPPL2012-11-07
4511SUPPL2012-10-26
14537SUPPL2012-01-23
14535SUPPL2012-01-23
4510SUPPL2012-01-23
4509SUPPL2012-01-23
23630ORIG2011-12-22
36248SUPPL2011-05-27
14536SUPPL2011-05-27
26945SUPPL2011-05-06
26944SUPPL2011-05-06
26943SUPPL2009-11-25
4508SUPPL2009-11-25
36247SUPPL2009-09-17
14534SUPPL2009-09-17
4507SUPPL2007-03-06
36246SUPPL2005-09-08
26942SUPPL2005-09-08
26941SUPPL2004-04-29
41996ORIG2004-03-11
36245ORIG2000-11-17
26940ORIG2000-11-17