NEPHRON FDA Approval ANDA 211445

ANDA 211445

NEPHRON

FDA Drug Application

Application #211445

Application Sponsors

ANDA 211445NEPHRON

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION30MG/ML0KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

NEPHRON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211445
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)

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