ANDA 201126

AM REGENT

FDA Drug Application

Application #201126

Application Sponsors

ANDA 201126

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2015-02-20

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201126
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESMOLOL HYDROCHLORIDE","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-02-20
        )

)