TAGI FDA Approval ANDA 212857

ANDA 212857

TAGI

FDA Drug Application

Application #212857

Application Sponsors

ANDA 212857TAGI

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)0DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)0DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE
003INJECTABLE;INJECTIONEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)0DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2020-06-09STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

TAGI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212857
            [companyName] => TAGI
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 80MCG BASE\/20ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 200MCG BASE\/50ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 400MCG BASE\/100ML (EQ 4MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-23
        )

)

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