ANDA 203773

AM REGENT

FDA Drug Application

Application #203773

Application Sponsors

ANDA 203773

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

0

DEXMEDETOMIDINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-12

Submissions Property Types

ORIG

1

Null

19

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203773
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMEDETOMIDINE HYDROCHLORIDE","activeIngredients":"DEXMEDETOMIDINE HYDROCHLORIDE","strength":"EQ 200MCG BASE\/2ML (EQ 100MCG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-12
        )

)