ANDA 215572

AMNEAL PHARMS LLC

FDA Drug Application

Application #215572

Documents

• Letter: 2022-08-30

Application Sponsors

ANDA 215572

AMNEAL PHARMS LLC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SUSPENSION;ORAL

25MG/5ML

0

SPIRONOLACTONE

SPIRONOLACTONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-07-11

UNKNOWN

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215572
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPIRONOLACTONE","activeIngredients":"SPIRONOLACTONE","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-11
        )

)