ANDA 203133

AMNEAL PHARMS LLC

FDA Drug Application

Application #203133

Documents

• Review: 2021-09-24

Application Sponsors

ANDA 203133

AMNEAL PHARMS LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION, EXTENDED RELEASE;ORAL

EQ 30MG HYDROBROMIDE/5ML

0

DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-28

Submissions Property Types

ORIG

1

Null

17

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203133
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROMETHORPHAN POLISTIREX","activeIngredients":"DEXTROMETHORPHAN POLISTIREX","strength":"EQ 30MG HYDROBROMIDE\/5ML","dosageForm":"SUSPENSION, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-28
        )

)