UPSHER SMITH LABS FDA Approval ANDA 084919

ANDA 084919

UPSHER SMITH LABS

FDA Drug Application

Application #084919

Application Sponsors

ANDA 084919UPSHER SMITH LABS

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL5MG0CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDE

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84919
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORDIAZEPOXIDE HYDROCHLORIDE","activeIngredients":"CHLORDIAZEPOXIDE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORDIAZEPOXIDE HYDROCHLORIDE","submission":"CHLORDIAZEPOXIDE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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