UNICHEM FDA Approval ANDA 212719

ANDA 212719

UNICHEM

FDA Drug Application

Application #212719

Application Sponsors

ANDA 212719UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL100MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE
002TABLET;ORAL200MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE
003TABLET;ORAL300MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-08STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212719
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-08
        )

)

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