ANDA 078055

SUN PHARM INDS LTD

FDA Drug Application

Application #078055

Documents

• Letter: 2007-05-01

Application Sponsors

ANDA 078055

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	5MG	0	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
002	TABLET;ORAL	10MG	0	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE

FDA Submissions

	ORIG	1	AP	2007-04-23
LABELING; Labeling	SUPPL	4	AP	2013-09-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-05-21	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	5	Null	7

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78055
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)