BOEHRINGER INGELHEIM FDA Approval ANDA 074662

ANDA 074662

BOEHRINGER INGELHEIM

FDA Drug Application

Application #074662

Application Sponsors

ANDA 074662BOEHRINGER INGELHEIM

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORALEQ 150MG BASE0RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDE
002TABLET;ORALEQ 300MG BASE0RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1997-08-29

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74662
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","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.