ANDA 215981

GRANULES

FDA Drug Application

Application #215981

Application Sponsors

ANDA 215981

GRANULES

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

2MG;125MG

0

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-29

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

GRANULES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215981
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE; SIMETHICONE","strength":"2MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-29
        )

)