PERRIGO ISRAEL FDA Approval ANDA 076592

ANDA 076592

PERRIGO ISRAEL

FDA Drug Application

Application #076592

Application Sponsors

ANDA 076592PERRIGO ISRAEL

Marketing Status

Prescription001

Application Products

001CREAM, AUGMENTED;TOPICALEQ 0.05% BASE0BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE

FDA Submissions

ORIG1AP2003-12-09
LABELING; LabelingSUPPL3AP2009-09-28
LABELING; LabelingSUPPL5AP2020-08-25STANDARD
LABELING; LabelingSUPPL7AP2020-08-25STANDARD

Submissions Property Types

SUPPL3Null7
SUPPL5Null15
SUPPL7Null15

TE Codes

001PrescriptionAB

CDER Filings

PERRIGO ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76592
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"CREAM, AUGMENTED;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETAMETHASONE DIPROPIONATE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"CREAM, AUGMENTED;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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