ANDA 213428

YICHANG HUMANWELL

FDA Drug Application

Application #213428

Application Sponsors

ANDA 213428

YICHANG HUMANWELL

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

2020-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

YICHANG HUMANWELL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213428
            [companyName] => YICHANG HUMANWELL
            [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":"11\/25\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)