telmisartan Oral Tablet

Brand(s)
Micardis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2014-12-18)
Oldest Current Product
2000-12-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\TELMISARTAN
FDAOB
ORAL\TABLET\TELMISARTAN
SPL Active
ORAL\TABLET\TELMISARTAN
SPL Moiety
ORAL\TABLET\TELMISARTAN

product(s) by strength(s)

telmisartan 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970039MicardisNDABoehringer Ingelheim Pharmaceuticals, Inc.2000-12-01TELMISARTANORALTABLETNDA020850cfb9309f-e0df-4a55-9542-0e869fce05fb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540542NDA AUTHORIZED GENERICRoxane Laboratories, Inc2014-01-08TELMISARTANORALTABLETNDA0208503181d225-4ceb-4071-bf45-7a8bd734b60f
2003782920ANDAMylan Pharmaceuticals Inc.2014-07-07TELMISARTANORALTABLETANDA202397c3658bc8-1524-43db-930e-66f9ac01b808
3005913292ANDAWatson Laboratories, Inc.2014-01-08TELMISARTANORALTABLETANDA07871019615482-4264-45e0-a6d5-fefd2cb06c6c
4006035914ANDAQualitest Pharmaceuticals2015-04-25TELMISARTANORALTABLETANDA2021300437f87a-cae2-4d9b-b671-2c2a1d38fa5c
5007815372ANDASandoz Inc2015-02-06TELMISARTANORALTABLETANDA2038678ba1e485-7c49-43d8-915e-f4180ef8eb23
6136680156ANDATorrent Pharmaceuticals Limited2014-07-07TELMISARTANORALTABLETANDA2031719006b2f8-4904-40c1-99ab-75cae8f3c2e7
7467080087ANDAAlembic Limited2013-03-06TELMISARTANORALTABLETANDA202130bbf22268-86af-41ca-b665-b9b185b57611
8658410804ANDACadila Healthcare Limited2014-08-27TELMISARTANORALTABLETANDA2033252e3cc412-fa44-4304-aabc-d6e412f81fbf
9658620867ANDAAurobindo Pharma Limited2015-09-03TELMISARTANORALTABLETANDA206511fef6532d-438a-435e-a61f-216dd8551339
10683820471ANDAZydus Pharmaceuticals (Usa) Inc.2014-08-27TELMISARTANORALTABLETANDA203325e61c209a-4fc3-4f5c-b526-6412f0b8897c
11684620199ANDAGlenmark Generics Inc., Usa2014-07-07TELMISARTANORALTABLETANDA090032c6eb489d-2946-4c14-839f-d4af761ead31

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1458650841Medsource PharmaceuticalsTELMISARTANORALTABLET683820471209b005e-12d7-3d34-e054-00144ff8d46c
2548686193MicardisNDAPhysicians Total Care, Inc.2010-11-02TELMISARTANORALTABLET005970039NDA0208503bb7bc69-7752-4c16-9c60-e61eb5355a4d

telmisartan 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970040MicardisNDABoehringer Ingelheim Pharmaceuticals, Inc.2000-12-01TELMISARTANORALTABLETNDA020850cfb9309f-e0df-4a55-9542-0e869fce05fb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540543NDA AUTHORIZED GENERICRoxane Laboratories, Inc2014-01-08TELMISARTANORALTABLETNDA0208503181d225-4ceb-4071-bf45-7a8bd734b60f
2003782921ANDAMylan Pharmaceuticals Inc.2014-07-07TELMISARTANORALTABLETANDA202397c3658bc8-1524-43db-930e-66f9ac01b808
3005913293ANDAWatson Laboratories, Inc.2014-01-08TELMISARTANORALTABLETANDA07871019615482-4264-45e0-a6d5-fefd2cb06c6c
4006035915ANDAQualitest Pharmaceuticals2015-04-25TELMISARTANORALTABLETANDA2021300437f87a-cae2-4d9b-b671-2c2a1d38fa5c
5007815374ANDASandoz Inc2015-02-06TELMISARTANORALTABLETANDA2038678ba1e485-7c49-43d8-915e-f4180ef8eb23
6467080088ANDAAlembic Limited2013-03-06TELMISARTANORALTABLETANDA202130bbf22268-86af-41ca-b665-b9b185b57611
7658620868ANDAAurobindo Pharma Limited2015-09-03TELMISARTANORALTABLETANDA206511fef6532d-438a-435e-a61f-216dd8551339
8684620200ANDAGlenmark Generics Inc., Usa2014-07-07TELMISARTANORALTABLETANDA090032c6eb489d-2946-4c14-839f-d4af761ead31

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684539MicardisNDAPhysicians Total Care, Inc.2005-01-19TELMISARTANORALTABLET005970040NDA0208503bb7bc69-7752-4c16-9c60-e61eb5355a4d

telmisartan 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970041MicardisNDABoehringer Ingelheim Pharmaceuticals, Inc.2000-12-01TELMISARTANORALTABLETNDA020850cfb9309f-e0df-4a55-9542-0e869fce05fb

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540544NDA AUTHORIZED GENERICRoxane Laboratories, Inc2014-01-08TELMISARTANORALTABLETNDA0208503181d225-4ceb-4071-bf45-7a8bd734b60f
2003782922ANDAMylan Pharmaceuticals Inc.2014-07-07TELMISARTANORALTABLETANDA202397c3658bc8-1524-43db-930e-66f9ac01b808
3005913294ANDAWatson Laboratories, Inc.2014-01-08TELMISARTANORALTABLETANDA07871019615482-4264-45e0-a6d5-fefd2cb06c6c
4006035916ANDAQualitest Pharmaceuticals2015-04-25TELMISARTANORALTABLETANDA2021300437f87a-cae2-4d9b-b671-2c2a1d38fa5c
5007815378ANDASandoz Inc2015-02-06TELMISARTANORALTABLETANDA2038678ba1e485-7c49-43d8-915e-f4180ef8eb23
6467080089ANDAAlembic Limited2013-03-06TELMISARTANORALTABLETANDA202130bbf22268-86af-41ca-b665-b9b185b57611
7658620869ANDAAurobindo Pharma Limited2015-09-03TELMISARTANORALTABLETANDA206511fef6532d-438a-435e-a61f-216dd8551339
8684620201ANDAGlenmark Generics Inc., Usa2014-07-07TELMISARTANORALTABLETANDA090032c6eb489d-2946-4c14-839f-d4af761ead31

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560298MicardisNDALake Erie Medical Dba Quality Care Products Llc2012-03-15TELMISARTANORALTABLET005970041NDA020850e29933dd-3e4e-4c43-973c-67e7398bf803
2548684605MicardisNDAPhysicians Total Care, Inc.2002-03-25TELMISARTANORALTABLET005970041NDA0208503bb7bc69-7752-4c16-9c60-e61eb5355a4d

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA078710TELMISARTANWATSON LABORATORIES INC2014-01-08PATENT CHALLENGE [2014-07-07]ANDA078710_001, ANDA078710_002, ANDA078710_003
2ANDA090032TELMISARTANGLENMARK GENERICS LTD2014-07-07ANDA090032_001, ANDA090032_002, ANDA090032_003
3ANDA202130TELMISARTANALEMBIC PHARMACEUTICALS LTD2014-07-07ANDA202130_001, ANDA202130_002, ANDA202130_003
4ANDA202397TELMISARTANMYLAN PHARMACEUTICALS INC2014-07-07ANDA202397_001, ANDA202397_002, ANDA202397_003
5ANDA203171TELMISARTANTORRENT PHARMACEUTICALS LTD2014-07-07ANDA203171_001, ANDA203171_002, ANDA203171_003
6ANDA203325TELMISARTANZYDUS PHARMACEUTICALS USA INC2014-08-26ANDA203325_001, ANDA203325_002, ANDA203325_003
7ANDA203867TELMISARTANSANDOZ INC2014-11-03ANDA203867_001, ANDA203867_002, ANDA203867_003
8ANDA204415TELMISARTANAMNEAL PHARMACEUTICALS2015-09-08ANDA204415_001, ANDA204415_002, ANDA204415_003
9ANDA205150TELMISARTANINVENTIA HEALTHCARE PRIVATE LTD2015-10-30ANDA205150_001, ANDA205150_002, ANDA205150_003
10ANDA206511TELMISARTANAUROBINDO PHARMA LTD2015-09-03ANDA206511_001, ANDA206511_002, ANDA206511_003
11NDA020850MICARDISBOEHRINGER INGELHEIM1998-11-10p6358986
p8003679, TREATMENT OR PREVENTION OF STROKE
p7998953, REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
NDA020850_001, NDA020850_002, NDA020850_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078710_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-01-08TELMISARTAN
2ANDA078710_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-01-08TELMISARTAN
3ANDA078710_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-01-08TELMISARTAN
4ANDA090032_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
5ANDA090032_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
6ANDA090032_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
7ANDA202130_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
8ANDA202130_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
9ANDA202130_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
10ANDA202397_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
11ANDA202397_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
12ANDA202397_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
13ANDA203171_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
14ANDA203171_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
15ANDA203171_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-07-07TELMISARTAN
16ANDA203325_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-08-26TELMISARTAN
17ANDA203325_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-08-26TELMISARTAN
18ANDA203325_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-08-26TELMISARTAN
19ANDA203867_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2014-11-03TELMISARTAN
20ANDA203867_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2014-11-03TELMISARTAN
21ANDA203867_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2014-11-03TELMISARTAN
22ANDA204415_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2015-09-08TELMISARTAN
23ANDA204415_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2015-09-08TELMISARTAN
24ANDA204415_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2015-09-08TELMISARTAN
25ANDA205150_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2015-10-30TELMISARTAN
26ANDA205150_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2015-10-30TELMISARTAN
27ANDA205150_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2015-10-30TELMISARTAN
28ANDA206511_001RXTELMISARTAN (20MG)ORALTABLETFalseAB2015-09-03TELMISARTAN
29ANDA206511_002RXTELMISARTAN (40MG)ORALTABLETFalseAB2015-09-03TELMISARTAN
30ANDA206511_003RXTELMISARTAN (80MG)ORALTABLETFalseAB2015-09-03TELMISARTAN
31NDA020850_001RXTELMISARTAN (40MG)ORALTABLETFalseAB1998-11-10MICARDIS
32NDA020850_002RXTELMISARTAN (80MG)ORALTABLETTrueAB1998-11-10MICARDIS
33NDA020850_003RXTELMISARTAN (20MG)ORALTABLETFalseAB2000-04-04MICARDIS

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6358986 (view patent)2020-01-10NDA020850, NDA021162Hydrochlorothiazide / telmisartan Oral Tablet
2p7998953 (view patent)2020-06-06NDA020850
3p8003679 (view patent)2022-10-06NDA020850

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10437f87a-cae2-4d9b-b671-2c2a1d38fa5c (view SPL)These highlights do not include all the information needed to use TELMISARTAN TABLETSsafely and effectively. See full prescribing information for TELMISARTAN TABLETS.TELMISARTANtablets,for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2015-10-2112006035914, 006035915, 006035916
219615482-4264-45e0-a6d5-fefd2cb06c6c (view SPL)These highlights do not include all the information needed to use telmisartan tablets safely and effectively. See full prescribing information for telmisartan tablets.TELMISARTAN tablets, USPfor oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2014-07-0112005913292, 005913293, 005913294
3209b005e-12d7-3d34-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use telmisartan safely and effectively. See full prescribing information for telmisartan. TELMISARTAN tablets, USP for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMedsource Pharmaceuticalsrelabel2015-09-251458650841
42e3cc412-fa44-4304-aabc-d6e412f81fbf (view SPL)These highlights do not include all the information needed to use telmisartan safely and effectively. See full prescribing information for telmisartan. TELMISARTAN tablets, USP for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2014-08-271658410804
53181d225-4ceb-4071-bf45-7a8bd734b60f (view SPL)These highlights do not include all the information needed to use Telmisartan Tablets USP safely and effectively. See full prescribing information for Telmisartan Tablets USP. Telmisartan Tablets USP Initial U.S. Approval: 1998prescriptionHuman PrescriptionRoxane Laboratories, IncANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-312000540542, 000540543, 000540544
63bb7bc69-7752-4c16-9c60-e61eb5355a4d (view SPL)These highlights do not include all the information needed to use MICARDIS safely and effectively. See full prescribing information for MICARDIS. MICARDIS (telmisartan) Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-145548684539, 548684605, 548686193
78ba1e485-7c49-43d8-915e-f4180ef8eb23 (view SPL)These highlights do not include all the information needed to use telmisartan tablets safely and effectively. See full prescribing information for telmisartan tablets.TELMISARTAN tablets, USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionSandoz Inc2015-08-206007815372, 007815374, 007815378
89006b2f8-4904-40c1-99ab-75cae8f3c2e7 (view SPL)These highlights do not include all the information needed to use telmisartan tablets safely and effectively. See full prescribing information for telmisartan tablets. TELMISARTAN Tablets, USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionTorrent Pharmaceuticals Limitedmanufacture2015-08-175136680156
9bbf22268-86af-41ca-b665-b9b185b57611 (view SPL)These highlights do not include all the information needed to use telmisartan safely and effectively. See full prescribing information for telmisartan.Telmisartan Tablets, USPInitial U.S. Approval: 1998prescriptionHuman PrescriptionAlembic LimitedMANUFACTURE2014-07-091467080087, 467080088, 467080089
10c3658bc8-1524-43db-930e-66f9ac01b808 (view SPL)These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-11-236003782920, 003782921, 003782922
11c6eb489d-2946-4c14-839f-d4af761ead31 (view SPL)These highlights do not include all the information needed to use telmisartan tablets safely and effectively. See full prescribing information for telmisartan tablets. TELMISARTAN Tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, API MANUFACTURE, MANUFACTURE2015-01-092684620199, 684620200, 684620201
12cfb9309f-e0df-4a55-9542-0e869fce05fb (view SPL)These highlights do not include all the information needed to use MICARDIS safely and effectively. See full prescribing information for MICARDIS. MICARDIS (telmisartan) TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-1821005970039, 005970040, 005970041
13e29933dd-3e4e-4c43-973c-67e7398bf803 (view SPL)These highlights do not include all the information needed to use MICARDIS safely and effectively. See full prescribing information for MICARDIS. MICARDIS (telmisartan) Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-153664353560298
14e61c209a-4fc3-4f5c-b526-6412f0b8897c (view SPL)These highlights do not include all the information needed to use telmisartan safely and effectively. See full prescribing information for telmisartan. TELMISARTAN tablets, USP for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2015-05-123683820471
15fef6532d-438a-435e-a61f-216dd8551339 (view SPL)These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-09-051658620867, 658620868, 658620869

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