STRIDES PHARMA FDA Approval ANDA 213070

ANDA 213070

STRIDES PHARMA

FDA Drug Application

Application #213070

Documents

Letter2021-09-02

Application Sponsors

ANDA 213070STRIDES PHARMA

Marketing Status

Over-the-counter001

Application Products

001CAPSULE;ORAL2MG0LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-11STANDARD

Submissions Property Types

ORIG1Null7

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
        )

)

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