STRIDES PHARMA FDA Approval ANDA 209160

ANDA 209160

STRIDES PHARMA

FDA Drug Application

Application #209160

Application Sponsors

ANDA 209160STRIDES PHARMA

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 75MG BASE0RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-03-05STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209160
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-05
        )

)

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