ANDA 208435

AREVA PHARMS

FDA Drug Application

Application #208435

Application Sponsors

ANDA 208435

AREVA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

FUROSEMIDE

FUROSEMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AREVA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208435
            [companyName] => AREVA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)