Documents
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
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
)
)