FDA.reportPublic FDA data

Application 200796

Type
NDA
Sponsor
ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDARBIAZILSARTAN KAMEDOXOMILTABLET;ORALEQ 40MG MEDOXOMILYesNo
002EDARBIAZILSARTAN KAMEDOXOMILTABLET;ORALEQ 80MG MEDOXOMILYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60631-040EdarbiAzilsartan kamedoxomilArbor PharmaceuticalsNDACurrent
60631-040EdarbiAzilsartan kamedoxomilArbor PharmaceuticalsNDACurrent
60631-040EdarbiAzilsartan kamedoxomilAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
60631-040EdarbiAzilsartan kamedoxomilArbor PharmaceuticalsNDACurrent
60631-080EdarbiAzilsartan kamedoxomilArbor PharmaceuticalsNDACurrent
60631-080EdarbiAzilsartan kamedoxomilArbor PharmaceuticalsNDACurrent
60631-080EdarbiAzilsartan kamedoxomilAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)NDACurrent
60631-080EdarbiAzilsartan kamedoxomilArbor PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77231SUPPL 2024-01-17
77230SUPPL 2024-01-17
62093SUPPL2020-03-10
62087SUPPL2020-03-09
45647SUPPL2016-10-26
32067SUPPL2014-08-04
18984SUPPL2014-07-24
32066SUPPL2014-04-21
18983SUPPL2012-10-05
9850SUPPL2012-10-04
32065SUPPL2011-12-15
18982SUPPL2011-12-14
40047SUPPL2011-04-15
32064SUPPL2011-04-15
22838ORIG2011-04-04
18981ORIG2011-03-04
32063ORIG2011-03-02