FDA.reportPublic FDA data

Application 205430

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 1MG BASENoNo
002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 2MG BASENoNo
003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 3MG BASENoNo
004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3927Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3928Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3929Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent
60505-3930Guanfacine extended-releaseguanfacineApotex Corp.ANDACurrent