ANDA 200536

STRIDES PHARMA

FDA Drug Application

Application #200536

Application Sponsors

ANDA 200536

STRIDES PHARMA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2011-06-28
LABELING; Labeling	SUPPL	6	AP	2015-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200536
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/11\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-11
        )

)