IMPAX LABS FDA Approval ANDA 080953

ANDA 080953

IMPAX LABS

FDA Drug Application

Application #080953

Application Sponsors

ANDA 080953IMPAX LABS

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORALEQ 50,000 UNITS BASE0VITAMIN AVITAMIN A PALMITATE

FDA Submissions

ORIG1AP1973-08-01
LABELING; LabelingSUPPL5AP2001-02-21

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80953
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VITAMIN A","activeIngredients":"VITAMIN A PALMITATE","strength":"EQ 50,000 UNITS BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VITAMIN A","submission":"VITAMIN A PALMITATE","actionType":"EQ 50,000 UNITS BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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