ANDA 072304

ALVOGEN

FDA Drug Application

Application #072304

Application Sponsors

ANDA 072304

ALVOGEN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

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

FDA Submissions

	ORIG	1	AP	1988-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-08-14
LABELING; Labeling	SUPPL	4	AP	1989-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-12-15
LABELING; Labeling	SUPPL	10	AP	1989-12-15
LABELING; Labeling	SUPPL	11	AP	1990-10-01
LABELING; Labeling	SUPPL	12	AP	1990-11-08
LABELING; Labeling	SUPPL	13	AP	1991-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-06-18
LABELING; Labeling	SUPPL	16	AP	1992-06-18
LABELING; Labeling	SUPPL	17	AP	1993-03-10
LABELING; Labeling	SUPPL	18	AP	1993-12-16
LABELING; Labeling	SUPPL	19	AP	1994-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-10-09
LABELING; Labeling	SUPPL	22	AP	1997-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-12-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-06-07

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72304
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)