ANDA 078687

HIKMA FARMACEUTICA

FDA Drug Application

Application #078687

Application Sponsors

ANDA 078687

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1.25MG/ML

0

ENALAPRILAT

ENALAPRILAT

FDA Submissions

	ORIG	1	AP	2008-12-23
LABELING; Labeling	SUPPL	6	AP	2010-04-29
LABELING; Labeling	SUPPL	7	AP	2010-09-27

Submissions Property Types

SUPPL

7

Null

8

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78687
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRILAT","activeIngredients":"ENALAPRILAT","strength":"1.25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENALAPRILAT","submission":"ENALAPRILAT","actionType":"1.25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)