ANDA 203725

HIKMA

FDA Drug Application

Application #203725

Application Sponsors

ANDA 203725

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	10MG/VIAL	0	VECURONIUM BROMIDE	VECURONIUM BROMIDE
002	INJECTABLE;INJECTION	20MG/VIAL	0	VECURONIUM BROMIDE	VECURONIUM BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-30

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203725
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-30
        )

)