ANDA 083718

HIKMA PHARMS

FDA Drug Application

Application #083718

Application Sponsors

ANDA 083718

HIKMA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

NIACIN

NIACIN

FDA Submissions

	ORIG	1	AP	1974-01-07
LABELING; Labeling	SUPPL	4	AP	1988-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-05-04
BIOEQUIV; Bioequivalence	SUPPL	12	AP	1989-05-17

Submissions Property Types

SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83718
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIACIN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NIACIN","submission":"NIACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)