REGCON SOLUTIONS FDA Approval ANDA 207842

ANDA 207842

REGCON SOLUTIONS

FDA Drug Application

Application #207842

Application Sponsors

ANDA 207842REGCON SOLUTIONS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL25MG0EPLERENONEEPLERENONE
002TABLET;ORAL50MG0EPLERENONEEPLERENONE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

REGCON SOLUTIONS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207842
            [companyName] => REGCON SOLUTIONS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPLERENONE","activeIngredients":"EPLERENONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPLERENONE","activeIngredients":"EPLERENONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-25
        )

)

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