ANDA 212705

AMNEAL PHARMS LLC

FDA Drug Application

Application #212705

Application Sponsors

ANDA 212705

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

25MG/ML

0

NAPROXEN

NAPROXEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212705
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"25MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-31
        )

)