HUMANWELL PURACAP FDA Approval ANDA 206568

ANDA 206568

HUMANWELL PURACAP

FDA Drug Application

Application #206568

Application Sponsors

ANDA 206568HUMANWELL PURACAP

Marketing Status

Over-the-counter001

Application Products

001CAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALT0IBUPROFENIBUPROFEN

FDA Submissions

UNKNOWN; ORIG1AP2016-06-21STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

HUMANWELL PURACAP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206568
            [companyName] => HUMANWELL PURACAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-21
        )

)

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