eprosartan Oral Tablet

Brand(s)
Teveten
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abbvie Inc. (2014-08-04)
Oldest Current Product
2010-05-24
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\EPROSARTAN
FDAOB
ORAL\TABLET\EPROSARTAN MESYLATE
SPL Active
ORAL\TABLET, FILM COATED\EPROSARTAN MESYLATE
ORAL\TABLET\EPROSARTAN MESYLATE
SPL Moiety
ORAL\TABLET, FILM COATED\EPROSARTAN
ORAL\TABLET\EPROSARTAN

product(s) by strength(s)

eprosartan 400 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743025TevetenNDAAbbvie Inc.2010-05-24EPROSARTAN MESYLATEORALTABLETNDA0207387cde57a7-eded-4c22-b1c7-98afc5546997

eprosartan 600 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743040TevetenNDAAbbvie Inc.2010-05-24EPROSARTAN MESYLATEORALTABLETNDA0207387cde57a7-eded-4c22-b1c7-98afc5546997

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786629ANDAMylan Pharmaceuticals Inc.2011-12-20EPROSARTAN MESYLATEORALTABLET, FILM COATEDANDA20201264fbc500-3b77-4c9c-8576-b3ec5f6655a5

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA202012EPROSARTAN MESYLATEMYLAN PHARMACEUTICALS INC2011-11-16ANDA202012_001, ANDA202012_002
2NDA020738TEVETENABBVIE INC1997-12-22p5656650, TREATMENT OF HYPERTENSIONNDA020738_004, NDA020738_005, NDA020738_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202012_001RXEPROSARTAN MESYLATE (EQ 400MG BASE)ORALTABLETFalseAB2011-11-16EPROSARTAN MESYLATE
2ANDA202012_002RXEPROSARTAN MESYLATE (EQ 600MG BASE)ORALTABLETFalseAB2011-11-16EPROSARTAN MESYLATE
3NDA020738_004discontinuedEPROSARTAN MESYLATE (EQ 300MG BASE)ORALTABLETFalse1997-12-22TEVETEN
4NDA020738_005RXEPROSARTAN MESYLATE (EQ 400MG BASE)ORALTABLETFalseAB1997-12-22TEVETEN
5NDA020738_006RXEPROSARTAN MESYLATE (EQ 600MG BASE)ORALTABLETTrueAB1999-05-27TEVETEN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5656650 (view patent)2014-08-12NDA020738, NDA021268eprosartan / Hydrochlorothiazide Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
164fbc500-3b77-4c9c-8576-b3ec5f6655a5 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-055003786629
27cde57a7-eded-4c22-b1c7-98afc5546997 (view SPL)TEVETEN (eprosartan mesylate) 400mg 600mgprescriptionHuman PrescriptionAbbvie Inc.2014-08-041428000743025, 000743040

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