ANDA 074499

SUN PHARM INDUSTRIES

FDA Drug Application

Application #074499

Application Sponsors

ANDA 074499

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

ATENOLOL

ATENOLOL

FDA Submissions

	ORIG	1	AP	1997-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-05-16
LABELING; Labeling	SUPPL	4	AP	2000-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-12-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-12-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-07-24
LABELING; Labeling	SUPPL	21	AP	2005-05-03
LABELING; Labeling	SUPPL	22	AP	2005-08-26
LABELING; Labeling	SUPPL	32	AP	2010-03-15
LABELING; Labeling	SUPPL	33	AP	2011-10-24
LABELING; Labeling	SUPPL	34	AP	2015-04-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	32	Null	7
SUPPL	33	Null	15
SUPPL	34	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74499
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)