STRIDES PHARMA FDA Approval ANDA 210010

ANDA 210010

STRIDES PHARMA

FDA Drug Application

Application #210010

Application Sponsors

ANDA 210010STRIDES PHARMA

Marketing Status

Discontinued001
Discontinued002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2018-08-01STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210010
            [companyName] => STRIDES PHARMA
            [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":"08\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-01
        )

)

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