ANDA 076474

MYLAN INSTITUTIONAL

FDA Drug Application

Application #076474

Application Sponsors

ANDA 076474

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-05-02
LABELING; Labeling	SUPPL	6	AP	2010-07-29

Submissions Property Types

SUPPL

6

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76474
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESMOLOL HYDROCHLORIDE","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESMOLOL HYDROCHLORIDE","submission":"ESMOLOL HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)