ANDA 200172

APOTEX INC

FDA Drug Application

Application #200172

Application Sponsors

ANDA 200172

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-05-31
LABELING; Labeling	SUPPL	5	AP	2016-11-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200172
            [companyName] => APOTEX INC
            [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":"05\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/14\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-11-14
        )

)