ANDA 211812

TEVA PHARMS USA INC

FDA Drug Application

Application #211812

Application Sponsors

ANDA 211812

TEVA PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

OXYMETAZOLINE

OXYMETAZOLINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-10-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)