TEVA PHARMS USA INC FDA Approval ANDA 211812

ANDA 211812

TEVA PHARMS USA INC

FDA Drug Application

Application #211812

Application Sponsors

ANDA 211812TEVA PHARMS USA INC

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL1%0OXYMETAZOLINEOXYMETAZOLINE

FDA Submissions

UNKNOWN; ORIG1TA2022-10-28STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211812
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYMETAZOLINE","activeIngredients":"OXYMETAZOLINE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-28
        )

)

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