ANDA 077824

AMNEAL PHARMS NY

FDA Drug Application

Application #077824

Application Sponsors

ANDA 077824

AMNEAL PHARMS NY

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

	ORIG	1	AP	2006-10-13
LABELING; Labeling	SUPPL	5	AP	2010-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2017-02-07	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	16	Null	15

CDER Filings

AMNEAL PHARMS NY

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77824
            [companyName] => AMNEAL PHARMS NY
            [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":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RANITIDINE HYDROCHLORIDE","submission":"RANITIDINE HYDROCHLORIDE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)