NDA 018760

ALVOGEN

FDA Drug Application

Application #018760

Documents

• Letter: 2003-12-02
• Letter: 2008-10-30
• Letter: 2012-11-01
• Label: 2011-08-24
• Label: 2012-11-02
• Letter: 2003-01-31
• Letter: 2005-02-11
• Letter: 2011-08-18
• Review: 2001-06-04
• Label: 2008-11-07
• Review: 2001-06-04

Application Sponsors

NDA 018760

ALVOGEN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	100MG;25MG	1	TENORETIC 100	ATENOLOL; CHLORTHALIDONE
002	TABLET;ORAL	50MG;25MG	1	TENORETIC 50	ATENOLOL; CHLORTHALIDONE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1984-06-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	1984-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-08-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-01-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	1991-04-26
LABELING; Labeling	SUPPL	11	AP	1991-04-26
LABELING; Labeling	SUPPL	12	AP	1991-04-26
LABELING; Labeling	SUPPL	13	AP	1991-09-18
LABELING; Labeling	SUPPL	14	AP	1992-08-05
LABELING; Labeling	SUPPL	15	AP	1992-08-05
LABELING; Labeling	SUPPL	16	AP	1993-04-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	1993-06-04	STANDARD
LABELING; Labeling	SUPPL	18	AP	1994-05-04	STANDARD
LABELING; Labeling	SUPPL	20	AP	1996-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1996-10-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2000-04-04	STANDARD
LABELING; Labeling	SUPPL	23	AP	1999-07-21	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-01-31	STANDARD
LABELING; Labeling	SUPPL	25	AP	2003-10-30	STANDARD
LABELING; Labeling	SUPPL	26	AP	2005-02-09	STANDARD
LABELING; Labeling	SUPPL	27	AP	2008-10-29	STANDARD
LABELING; Labeling	SUPPL	28	AP	2011-08-21	UNKNOWN
LABELING; Labeling	SUPPL	29	AP	2012-10-31	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	21	Null	0
SUPPL	28	Null	15
SUPPL	29	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18760
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENORETIC 100","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"100MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TENORETIC 50","activeIngredients":"ATENOLOL; CHLORTHALIDONE","strength":"50MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/31\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018760s029lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2011","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018760s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2008","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018760s027lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TENORETIC 100","submission":"ATENOLOL; CHLORTHALIDONE","actionType":"100MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TENORETIC 50","submission":"ATENOLOL; CHLORTHALIDONE","actionType":"50MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-10-31
        )

)