HETERO LABS LTD V FDA Approval ANDA 211438

ANDA 211438

HETERO LABS LTD V

FDA Drug Application

Application #211438

Application Sponsors

ANDA 211438HETERO LABS LTD V

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL2MG;125MG0LOPERAMIDE HYDROCHLORIDE AND SIMETHICONELOPERAMIDE HYDROCHLORIDE; SIMETHICONE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-17STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211438
            [companyName] => HETERO LABS LTD V
            [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":"06\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-17
        )

)

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