ANDA 205430

APOTEX

FDA Drug Application

Application #205430

Application Sponsors

ANDA 205430

APOTEX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 2MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 3MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	EQ 4MG BASE	0	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205430
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GUANFACINE HYDROCHLORIDE","activeIngredients":"GUANFACINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/30\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-30
        )

)