ANDA 215788

HAVIX

FDA Drug Application

Application #215788

Application Sponsors

ANDA 215788

HAVIX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-23

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

HAVIX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215788
            [companyName] => HAVIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-23
        )

)