NDA 019507

SANOFI AVENTIS US

FDA Drug Application

Application #019507

Documents

• Letter: 2008-08-13
• Letter: 2011-08-18
• Letter: 2009-05-14
• Label: 2009-07-08
• Label: 2011-08-24

Application Sponsors

NDA 019507

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	KERLONE	BETAXOLOL HYDROCHLORIDE
002	TABLET;ORAL	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	KERLONE	BETAXOLOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-10-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	1992-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-01-27	STANDARD
LABELING; Labeling	SUPPL	6	AP	2008-08-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2009-05-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2011-08-17	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19507
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"KERLONE","activeIngredients":"BETAXOLOL HYDROCHLORIDE","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KERLONE","activeIngredients":"BETAXOLOL HYDROCHLORIDE","strength":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/17\/2011","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019507s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2009","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019507s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KERLONE","submission":"BETAXOLOL HYDROCHLORIDE","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KERLONE","submission":"BETAXOLOL HYDROCHLORIDE","actionType":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-08-17
        )

)