ALEMBIC PHARMS LTD FDA Approval ANDA 214456

ANDA 214456

ALEMBIC PHARMS LTD

FDA Drug Application

Application #214456

Application Sponsors

ANDA 214456ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-11-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214456
            [companyName] => ALEMBIC PHARMS LTD
            [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":"11\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-02
        )

)

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