ANDA 214541

GUARDIAN DRUG

FDA Drug Application

Application #214541

Application Sponsors

ANDA 214541

GUARDIAN DRUG

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

2021-05-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GUARDIAN DRUG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214541
            [companyName] => GUARDIAN DRUG
            [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":"05\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-27
        )

)