ANDA 074568

PLIVA

FDA Drug Application

Application #074568

Application Sponsors

ANDA 074568

PLIVA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	200MG	0	CIMETIDINE	CIMETIDINE
002	TABLET;ORAL	300MG	0	CIMETIDINE	CIMETIDINE
003	TABLET;ORAL	400MG	0	CIMETIDINE	CIMETIDINE

FDA Submissions

	ORIG	1	AP	1997-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-07-07
LABELING; Labeling	SUPPL	9	AP	2005-03-03

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74568
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)