ANDA 205512

STRIDES PHARMA

FDA Drug Application

Application #205512

Application Sponsors

ANDA 205512

STRIDES PHARMA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 150MG BASE	0	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 300MG BASE	0	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2019-03-22

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205512
            [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\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/22\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-03-22
        )

)