ANDA 207707

HIKMA INTL PHARMS

FDA Drug Application

Application #207707

Application Sponsors

ANDA 207707

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	40MG/ML	0	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	80MG/ML	0	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207707
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOPAMINE HYDROCHLORIDE","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOPAMINE HYDROCHLORIDE","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-11
        )

)