FDA.reportPublic FDA data

Application 202331

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDARBYCLORAZILSARTAN KAMEDOXOMIL; CHLORTHALIDONETABLET;ORALEQ 40MG MEDOXOMIL;12.5MGYesNo
002EDARBYCLORAZILSARTAN KAMEDOXOMIL; CHLORTHALIDONETABLET;ORALEQ 40MG MEDOXOMIL;25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60631-412EdarbyclorAzilsartan kamedoxomil and chlorthalidoneArbor PharmaceuticalsNDACurrent
60631-412EdarbyclorAzilsartan kamedoxomil and chlorthalidoneAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
60631-412EdarbyclorAzilsartan kamedoxomil and chlorthalidoneArbor PharmaceuticalsNDACurrent
60631-412EdarbyclorAzilsartan kamedoxomil and chlorthalidoneArbor PharmaceuticalsNDACurrent
60631-425EdarbyclorAzilsartan kamedoxomil and chlorthalidoneArbor PharmaceuticalsNDACurrent
60631-425EdarbyclorAzilsartan kamedoxomil and chlorthalidoneAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
60631-425EdarbyclorAzilsartan kamedoxomil and chlorthalidoneArbor PharmaceuticalsNDACurrent
60631-425EdarbyclorAzilsartan kamedoxomil and chlorthalidoneArbor PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73773SUPPL 2023-03-15
62109SUPPL2020-03-10
62105SUPPL2020-03-10
45646SUPPL2016-10-26
40168SUPPL2015-04-17
32236SUPPL2015-04-17
32235SUPPL2014-07-24
19322SUPPL2014-07-24
10027SUPPL2014-04-21
19321SUPPL2012-10-05
10026SUPPL2012-10-04
44852ORIG2012-08-16
22886ORIG2012-08-16
19320ORIG2012-01-24
32234ORIG2011-12-27