AVANTHI INC FDA Approval ANDA 040829

ANDA 040829

AVANTHI INC

FDA Drug Application

Application #040829

Application Sponsors

ANDA 040829AVANTHI INC

Marketing Status

Over-the-counter001

Application Products

001TABLET, EXTENDED RELEASE;ORAL12MG0CHLORPHENIRAMINE MALEATECHLORPHENIRAMINE MALEATE

FDA Submissions

ORIG1AP2009-05-13

CDER Filings

AVANTHI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40829
            [companyName] => AVANTHI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPHENIRAMINE MALEATE","activeIngredients":"CHLORPHENIRAMINE MALEATE","strength":"12MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPHENIRAMINE MALEATE","submission":"CHLORPHENIRAMINE MALEATE","actionType":"12MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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