ANI PHARMS INC FDA Approval ANDA 090625

ANDA 090625

ANI PHARMS INC

FDA Drug Application

Application #090625

Documents

Letter2012-05-18

Application Sponsors

ANDA 090625ANI PHARMS INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 300MG BASE0CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATE

FDA Submissions

ORIG1AP2012-05-17

Submissions Property Types

ORIG1Null7

CDER Filings

ANI PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90625
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOPIDOGREL BISULFATE","submission":"CLOPIDOGREL BISULFATE","actionType":"EQ 300MG 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.