azilsartan Oral Tablet

Brand(s)
Edarbi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Takeda Pharmaceuticals America, Inc. (2012-10-31)
Oldest Current Product
2011-02-25
License(s)
NDA
RxNORM
ORAL TABLET\AZILSARTAN
FDAOB
ORAL\TABLET\AZILSARTAN KAMEDOXOMIL
SPL Active
ORAL\TABLET\AZILSARTAN KAMEDOXOMIL
SPL Moiety
ORAL\TABLET\AZILSARTAN

product(s) by strength(s)

azilsartan medoxomil 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640844EdarbiNDATakeda Pharmaceuticals America, Inc.2011-02-25AZILSARTAN KAMEDOXOMILORALTABLETNDA20079675b16bfc-38c1-4133-bd7d-13258d54edec

azilsartan medoxomil 80 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647640884EdarbiNDATakeda Pharmaceuticals America, Inc.2011-02-25AZILSARTAN KAMEDOXOMILORALTABLETNDA20079675b16bfc-38c1-4133-bd7d-13258d54edec

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200796EDARBIARBOR PHARMACEUTICALS IRELAND LTD2011-02-25p7157584
p7572920, TREATMENT OF HYPERTENSION, SUBSTANCE
p9066936, SUBSTANCE
NEW CHEMICAL ENTITY [2016-02-25]NDA200796_001, NDA200796_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200796_001RXAZILSARTAN KAMEDOXOMIL (EQ 40MG MEDOXOMIL)ORALTABLETFalse2011-02-25EDARBI
2NDA200796_002RXAZILSARTAN KAMEDOXOMIL (EQ 80MG MEDOXOMIL)ORALTABLETTrue2011-02-25EDARBI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7157584 (view patent)2025-05-22NDA200796, NDA202331azilsartan / Chlorthalidone Oral Tablet
2p7572920 (view patent)2025-01-07NDA200796, NDA202331azilsartan / Chlorthalidone Oral Tablet
3p9066936 (view patent)2028-03-26NDA200796, NDA202331azilsartan / Chlorthalidone Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
152b27c75-9f5a-4816-bafd-dace9d7d2063 (view SPL)These HIGHLIGHTS do not include all the information needed to use EDARBI safely and effectively. See full prescribing information for EDARBI. Edarbi (azilsartan medoxomil) tablets Initial U.S. Approval: 2011prescriptionHuman PrescriptionArbor Pharmaceuticals2015-08-204606310040, 606310080
275b16bfc-38c1-4133-bd7d-13258d54edec (view SPL)These HIGHLIGHTS do not include all the information needed to use EDARBI safely and effectively. See full prescribing information for EDARBI. Edarbi (azilsartan medoxomil) tabletsInitial U.S. Approval: 2011prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2012-10-317647640844, 647640884

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