GLAND PHARMA LTD FDA Approval ANDA 209307

ANDA 209307

GLAND PHARMA LTD

FDA Drug Application

Application #209307

Application Sponsors

ANDA 209307GLAND PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-06-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209307
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"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":"06\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-03
        )

)

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