ANDA 083823

SANOFI AVENTIS US

FDA Drug Application

Application #083823

Application Sponsors

ANDA 083823

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

NICOLAR

NIACIN

FDA Submissions

	ORIG	1	AP	1973-11-26
LABELING; Labeling	SUPPL	9	AP	1993-02-01
LABELING; Labeling	SUPPL	10	AP	1993-05-27

Submissions Property Types

ORIG	1	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83823
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOLAR","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NICOLAR","submission":"NIACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)