ANDA 210356

FRESENIUS KABI USA

FDA Drug Application

Application #210356

Application Sponsors

ANDA 210356

FRESENIUS KABI USA

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

HALOPERIDOL

HALOPERIDOL LACTATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210356
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL","activeIngredients":"HALOPERIDOL LACTATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-01
        )

)