azilsartan / Chlorthalidone Oral Tablet

Brand(s)
Edarbyclor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Arbor Pharmaceuticals (2015-11-20)
Oldest Current Product
2013-02-01
License(s)
NDA
RxNORM
ORAL TABLET\AZILSARTAN:CHLORTHALIDONE
FDAOB
ORAL\TABLET\AZILSARTAN KAMEDOXOMIL: CHLORTHALIDONE
SPL Active
ORAL\TABLET\AZILSARTAN KAMEDOXOMIL: CHLORTHALIDONE
SPL Moiety
ORAL\TABLET\AZILSARTAN: CHLORTHALIDONE

product(s) by strength(s)

azilsartan medoxomil 40 mg / chlorthalidone 12.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1606310412EdarbyclorNDAArbor Pharmaceuticals2013-02-01AZILSARTAN KAMEDOXOMIL, CHLORTHALIDONEORALTABLETNDA202331e60f795b-fce3-4361-aa03-f143451689d1

azilsartan medoxomil 40 mg / chlorthalidone 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1606310425EdarbyclorNDAArbor Pharmaceuticals2013-02-01AZILSARTAN KAMEDOXOMIL, CHLORTHALIDONEORALTABLETNDA202331e60f795b-fce3-4361-aa03-f143451689d1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202331EDARBYCLORARBOR PHARMACEUTICALS IRELAND LTD2011-12-20p7157584
p7572920, TREATMENT OF HYPERTENSION, SUBSTANCE
p9066936, SUBSTANCE
NEW CHEMICAL ENTITY [2016-02-25]
NEW COMBINATION [2014-12-20]
NDA202331_001, NDA202331_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202331_001RXCHLORTHALIDONE (12.5MG), AZILSARTAN KAMEDOXOMIL (EQ 40MG MEDOXOMIL)ORALTABLETFalse2011-12-20EDARBYCLOR
2NDA202331_002RXCHLORTHALIDONE (25MG), AZILSARTAN KAMEDOXOMIL (EQ 40MG MEDOXOMIL)ORALTABLETTrue2011-12-20EDARBYCLOR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7157584 (view patent)2025-05-22NDA202331, NDA200796azilsartan Oral Tablet
2p7572920 (view patent)2025-01-07NDA202331, NDA200796azilsartan Oral Tablet
3p9066936 (view patent)2028-03-26NDA202331, NDA200796azilsartan Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b2d6e17b-f14a-463b-a662-03c9387c63dd (view SPL)These highlights do not include all the information needed to use EDARBYCLOR safely and effectively. See full prescribing information for EDARBYCLOR. EDARBYCLOR (azilsartan medoxomil and chlorthalidone) tablets, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionTakeda Pharmaceuticals America, Inc.2012-10-313647640944, 647640994
2e60f795b-fce3-4361-aa03-f143451689d1 (view SPL)These highlights do not include all the information needed to use EDARBYCLOR safely and effectively. See full prescribing information for EDARBYCLOR. EDARBYCLOR (azilsartan medoxomil and chlorthalidone) tablets, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionArbor Pharmaceuticals2015-11-206606310412, 606310425

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