ANDA 204386

BRECKENRIDGE

FDA Drug Application

Application #204386

Application Sponsors

ANDA 204386

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

BRETYLIUM TOSYLATE

BRETYLIUM TOSYLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-21

Submissions Property Types

ORIG

1

Null

1

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204386
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRETYLIUM TOSYLATE","activeIngredients":"BRETYLIUM TOSYLATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)