ANDA 208197

EUROHLTH INTL SARL

FDA Drug Application

Application #208197

Application Sponsors

ANDA 208197

EUROHLTH INTL SARL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2.5MG/ML

0

DROPERIDOL

DROPERIDOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

EUROHLTH INTL SARL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208197
            [companyName] => EUROHLTH INTL SARL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROPERIDOL","activeIngredients":"DROPERIDOL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-14
        )

)