GUARDIAN DRUG FDA Approval ANDA 207569

ANDA 207569

GUARDIAN DRUG

FDA Drug Application

Application #207569

Application Sponsors

ANDA 207569GUARDIAN DRUG

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL10MG0LORATADINELORATADINE

FDA Submissions

UNKNOWN; ORIG1AP2019-03-12STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

GUARDIAN DRUG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207569
            [companyName] => GUARDIAN DRUG
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-12
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.