ANDA 090038

HIKMA FARMACEUTICA

FDA Drug Application

Application #090038

Application Sponsors

ANDA 090038

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)	0	MILRINONE LACTATE IN PLASTIC CONTAINER	MILRINONE LACTATE
002	INJECTABLE;INJECTION	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	0	MILRINONE LACTATE IN PLASTIC CONTAINER	MILRINONE LACTATE

FDA Submissions

ORIG

1

AP

2010-01-21

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90038
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MILRINONE LACTATE IN PLASTIC CONTAINER","activeIngredients":"MILRINONE LACTATE","strength":"EQ 20MG BASE\/100ML (EQ 0.2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MILRINONE LACTATE IN PLASTIC CONTAINER","activeIngredients":"MILRINONE LACTATE","strength":"EQ 40MG BASE\/200ML (EQ 0.2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MILRINONE LACTATE IN PLASTIC CONTAINER","submission":"MILRINONE LACTATE","actionType":"EQ 20MG BASE\/100ML (EQ 0.2MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MILRINONE LACTATE IN PLASTIC CONTAINER","submission":"MILRINONE LACTATE","actionType":"EQ 40MG BASE\/200ML (EQ 0.2MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)