FDA.reportPublic FDA data

Application 022331

Type
NDA
Sponsor
CONCORDIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JENLOGACLONIDINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002JENLOGACLONIDINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003KAPVAYCLONIDINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.1MGYesYes
004KAPVAYCLONIDINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
59212-658Kapvayclonidine hydrochlorideConcordia Pharmaceuticals Inc.NDACurrent
66993-776Clonidine hydrochloride extended-releaseclonidine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-776Clonidine hydrochloride extended-releaseclonidine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-776Clonidine hydrochloride extended-releaseclonidine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61848SUPPL2020-02-07
61838SUPPL2020-02-07
48433SUPPL2017-05-17
45195SUPPL2016-08-16
45130SUPPL2016-08-16
38587SUPPL2015-06-10
29606SUPPL2015-06-10
17250SUPPL2014-12-16
29605SUPPL2014-11-21
17249SUPPL2013-02-14
7246SUPPL2013-02-14
38586SUPPL2010-10-07
17248SUPPL2010-10-07
17247SUPPL2010-10-07
29604SUPPL2010-10-04
29603SUPPL2010-10-04
21995ORIG2009-11-10
38585ORIG2009-10-07
7245ORIG2009-10-07
66954ORIG1900-01-01
66953ORIG1900-01-01
66952ORIG1900-01-01
53219ORIG1900-01-01
53218ORIG1900-01-01
53216ORIG1900-01-01