FRESENIUS KABI USA FDA Approval ANDA 203242

ANDA 203242

FRESENIUS KABI USA

FDA Drug Application

Application #203242

Application Sponsors

ANDA 203242FRESENIUS KABI USA

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION15MG/ML0KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE
002INJECTABLE;INJECTION30MG/ML0KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE

FDA Submissions

UNKNOWN; ORIG1AP2015-10-07
LABELING; LabelingSUPPL6AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL6Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203242
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-10-07
        )

)

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