HETERO LABS LTD III FDA Approval ANDA 216651

ANDA 216651

HETERO LABS LTD III

FDA Drug Application

Application #216651

Application Sponsors

ANDA 216651HETERO LABS LTD III

Marketing Status

Prescription001

Application Products

001TABLET;ORAL10MG0KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216651
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-25
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.