PADAGIS ISRAEL FDA Approval ANDA 215847

ANDA 215847

PADAGIS ISRAEL

FDA Drug Application

Application #215847

Application Sponsors

ANDA 215847PADAGIS ISRAEL

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICALEQ 0.05% BASE0BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-12STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

PADAGIS ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215847
            [companyName] => PADAGIS ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-12
        )

)

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