YUNG SHIN PHARM FDA Approval ANDA 202297

ANDA 202297

YUNG SHIN PHARM

FDA Drug Application

Application #202297

Application Sponsors

ANDA 202297YUNG SHIN PHARM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL0.1MG0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE
002TABLET;ORAL0.2MG0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE
003TABLET;ORAL0.3MG0CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2013-06-13

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

YUNG SHIN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202297
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-06-13
        )

)

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