UNICHEM FDA Approval ANDA 213302

ANDA 213302

UNICHEM

FDA Drug Application

Application #213302

Application Sponsors

ANDA 213302UNICHEM

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL50MG;25MG0ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE
002TABLET;ORAL100MG;25MG0ATENOLOL AND CHLORTHALIDONEATENOLOL; CHLORTHALIDONE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213302
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"50MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"100MG;25MG","dosageForm":"TABLET;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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