AKORN FDA Approval ANDA 206312

ANDA 206312

AKORN

FDA Drug Application

Application #206312

Application Sponsors

ANDA 206312AKORN

Marketing Status

Prescription001

Application Products

001PASTE;DENTAL0.1%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-08-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206312
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"PASTE;DENTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-11
        )

)

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