ANDA 074265

INVATECH

FDA Drug Application

Application #074265

Application Sponsors

ANDA 074265

INVATECH

Marketing Status

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

Application Products

001	TABLET;ORAL	25MG	0	ATENOLOL	ATENOLOL
002	TABLET;ORAL	50MG	0	ATENOLOL	ATENOLOL
003	TABLET;ORAL	100MG	0	ATENOLOL	ATENOLOL

FDA Submissions

	ORIG	1	AP	1994-02-28
LABELING; Labeling	SUPPL	2	AP	1994-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-03-13
LABELING; Labeling	SUPPL	5	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-06-04
LABELING; Labeling	SUPPL	9	AP	1997-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-10-21
LABELING; Labeling	SUPPL	11	AP	1997-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-01-27

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74265
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","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"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)