TARO FDA Approval ANDA 089024

ANDA 089024

TARO

FDA Drug Application

Application #089024

Application Sponsors

ANDA 089024TARO

Marketing Status

Discontinued001

Application Products

001LOTION;TOPICAL1%0HYDROCORTISONEHYDROCORTISONE

FDA Submissions

ORIG1AP1986-02-12
LABELING; LabelingSUPPL5AP1988-05-09
LABELING; LabelingSUPPL9AP1992-04-17
LABELING; LabelingSUPPL10AP1992-11-02

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89024
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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