YICHANG HUMANWELL FDA Approval ANDA 213428

ANDA 213428

YICHANG HUMANWELL

FDA Drug Application

Application #213428

Application Sponsors

ANDA 213428YICHANG HUMANWELL

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 1MG BASE0GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORALEQ 2MG BASE0GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDE
003TABLET, EXTENDED RELEASE;ORALEQ 3MG BASE0GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDE
004TABLET, EXTENDED RELEASE;ORALEQ 4MG BASE0GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

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
        )

)

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