UPSHER SMITH LABS FDA Approval ANDA 213571

ANDA 213571

UPSHER SMITH LABS

FDA Drug Application

Application #213571

Application Sponsors

ANDA 213571UPSHER SMITH LABS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL40MG0ISOTRETINOINISOTRETINOIN

FDA Submissions

UNKNOWN; ORIG1AP2021-04-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB2

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213571
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOTRETINOIN","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-12
        )

)

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