HI TECH FDA Approval ANDA 209896

ANDA 209896

HI TECH

FDA Drug Application

Application #209896

Application Sponsors

ANDA 209896HI TECH

Marketing Status

Prescription001

Application Products

001LOTION;TOPICALEQ 0.05% BASE0BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE

FDA Submissions

UNKNOWN; ORIG1AP2018-02-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209896
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-06
        )

)

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