ANDA 065174

SUN PHARM INDS LTD

FDA Drug Application

Application #065174

Documents

• Other Important Information from FDA: 2006-03-03

Application Sponsors

ANDA 065174

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	250MG	0	CLARITHROMYCIN	CLARITHROMYCIN
002	TABLET;ORAL	500MG	0	CLARITHROMYCIN	CLARITHROMYCIN

FDA Submissions

	ORIG	1	AP	2004-09-24
LABELING; Labeling	SUPPL	3	AP	2007-04-16
LABELING; Labeling	SUPPL	7	AP	2008-09-16
LABELING; Labeling	SUPPL	8	AP	2012-09-05	STANDARD
LABELING; Labeling	SUPPL	9	AP	2013-07-11	STANDARD

Submissions Property Types

SUPPL	8	Null	24
SUPPL	9	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65174
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLARITHROMYCIN","submission":"CLARITHROMYCIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLARITHROMYCIN","submission":"CLARITHROMYCIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)