ANDA 213070

STRIDES PHARMA

FDA Drug Application

Application #213070

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 213070

STRIDES PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

2MG

0

LOPERAMIDE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213070
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-11
        )

)