ANDA 074107

PLIVA

FDA Drug Application

Application #074107

Application Sponsors

ANDA 074107

PLIVA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	50MG;25MG	0	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE
002	TABLET;ORAL	100MG;25MG	0	ATENOLOL AND CHLORTHALIDONE	ATENOLOL; CHLORTHALIDONE

FDA Submissions

	ORIG	1	AP	1997-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07
LABELING; Labeling	SUPPL	3	AP	2001-04-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74107
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"50MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL AND CHLORTHALIDONE","submission":"ATENOLOL; CHLORTHALIDONE","actionType":"50MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL AND CHLORTHALIDONE","submission":"ATENOLOL; CHLORTHALIDONE","actionType":"100MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)