PAR STERILE PRODUCTS FDA Approval ANDA 208266

ANDA 208266

PAR STERILE PRODUCTS

FDA Drug Application

Application #208266

Application Sponsors

ANDA 208266PAR STERILE PRODUCTS

Marketing Status

None (Tentative Approval)001
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; ORIG1AP2020-09-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

PAR STERILE PRODUCTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208266
            [companyName] => PAR STERILE PRODUCTS
            [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":"09\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-15
        )

)

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