NDA 019807

SANOFI AVENTIS US

FDA Drug Application

Application #019807

Documents

• Letter: 2011-03-24
• Label: 2011-08-24
• Letter: 2011-08-24
• Label: 2011-03-28

Application Sponsors

NDA 019807

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	5MG;12.5MG	0	KERLEDEX	BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE
002	TABLET;ORAL	10MG;12.5MG	0	KERLEDEX	BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1992-10-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2011-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19807
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"KERLEDEX","activeIngredients":"BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE","strength":"5MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KERLEDEX","activeIngredients":"BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE","strength":"10MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/2011","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019807s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2011","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019807s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KERLEDEX","submission":"BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE","actionType":"5MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KERLEDEX","submission":"BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE","actionType":"10MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2011-08-20
        )

)