ANDA 072302

ALVOGEN

FDA Drug Application

Application #072302

Application Sponsors

ANDA 072302

ALVOGEN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	1990-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-04-30
LABELING; Labeling	SUPPL	3	AP	1992-03-03
LABELING; Labeling	SUPPL	4	AP	1993-04-07
LABELING; Labeling	SUPPL	5	AP	1993-10-22
LABELING; Labeling	SUPPL	6	AP	1994-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-07-12
LABELING; Labeling	SUPPL	9	AP	1997-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-01-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72302
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL AND CHLORTHALIDONE","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"50MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL AND CHLORTHALIDONE","submission":"ATENOLOL; CHLORTHALIDONE","actionType":"100MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL AND CHLORTHALIDONE","submission":"ATENOLOL; CHLORTHALIDONE","actionType":"50MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)