PERRIGO ISRAEL FDA Approval ANDA 076479

ANDA 076479

PERRIGO ISRAEL

FDA Drug Application

Application #076479

Application Sponsors

ANDA 076479PERRIGO ISRAEL

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL1%0ECONAZOLE NITRATEECONAZOLE NITRATE

FDA Submissions

ORIG1AP2004-06-23

TE Codes

001PrescriptionAB

CDER Filings

PERRIGO ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76479
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ECONAZOLE NITRATE","activeIngredients":"ECONAZOLE NITRATE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ECONAZOLE NITRATE","submission":"ECONAZOLE NITRATE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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