MYLAN PHARMS INC FDA Approval ANDA 090323

ANDA 090323

MYLAN PHARMS INC

FDA Drug Application

Application #090323

Documents

Letter2012-03-29

Application Sponsors

ANDA 090323MYLAN PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 25MG BASE0QUETIAPINE FUMARATEQUETIAPINE FUMARATE

FDA Submissions

ORIG1AP2012-03-27

Submissions Property Types

ORIG1Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90323
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUETIAPINE FUMARATE","submission":"QUETIAPINE FUMARATE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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