CAPLIN FDA Approval ANDA 214533

ANDA 214533

CAPLIN

FDA Drug Application

Application #214533

Application Sponsors

ANDA 214533CAPLIN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION5MG/ML0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

CAPLIN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214533
            [companyName] => CAPLIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-07
        )

)

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