ANDA 200219

HIKMA FARMACEUTICA

FDA Drug Application

Application #200219

Application Sponsors

ANDA 200219

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10USP UNITS/ML (10USP UNITS/ML)

0

OXYTOCIN

OXYTOCIN

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2013-02-13

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200219
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYTOCIN","activeIngredients":"OXYTOCIN","strength":"10USP UNITS\/ML (10USP UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-02-13
        )

)