ZYDUS FDA Approval ANDA 212178

ANDA 212178

ZYDUS

FDA Drug Application

Application #212178

Application Sponsors

ANDA 212178ZYDUS

Marketing Status

Prescription001

Application Products

001SOLUTION;TOPICAL10%0EFINACONAZOLEEFINACONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212178
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFINACONAZOLE","activeIngredients":"EFINACONAZOLE","strength":"10%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-15
        )

)

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