ANDA 077990

YUNG SHIN PHARM

FDA Drug Application

Application #077990

Documents

• Letter: 2007-05-01

Application Sponsors

ANDA 077990

YUNG SHIN PHARM

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	2	AP	2009-10-20
LABELING; Labeling	SUPPL	3	AP	2011-02-04
LABELING; Labeling	SUPPL	5	AP	2014-12-29	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77990
            [companyName] => YUNG SHIN PHARM
            [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
        )

)