ANDA 212668

PRINSTON INC

FDA Drug Application

Application #212668

Application Sponsors

ANDA 212668

PRINSTON INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	50MG/5ML (10MG/ML)	0	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE
002	INJECTABLE;INJECTION	100MG/10ML (10MG/ML)	0	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212668
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)