PERRIGO ISRAEL FDA Approval ANDA 077180

ANDA 077180

PERRIGO ISRAEL

FDA Drug Application

Application #077180

Application Sponsors

ANDA 077180PERRIGO ISRAEL

Marketing Status

Prescription001

Application Products

001LOTION;TOPICAL0.1%0MOMETASONE FUROATEMOMETASONE FUROATE

FDA Submissions

ORIG1AP2005-04-06
LABELING; LabelingSUPPL4AP2015-07-27STANDARD
LABELING; LabelingSUPPL9AP2019-10-08STANDARD

Submissions Property Types

SUPPL4Null7
SUPPL9Null7

TE Codes

001PrescriptionAB

CDER Filings

PERRIGO ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77180
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOMETASONE FUROATE","activeIngredients":"MOMETASONE FUROATE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MOMETASONE FUROATE","submission":"MOMETASONE FUROATE","actionType":"0.1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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