ANDA 091151

MYLAN PHARMS INC

FDA Drug Application

Application #091151

Documents

• Review: 2013-04-10

Application Sponsors

ANDA 091151

MYLAN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	1MG	0	ESZOPICLONE	ESZOPICLONE
002	TABLET;ORAL	2MG	0	ESZOPICLONE	ESZOPICLONE
003	TABLET;ORAL	3MG	0	ESZOPICLONE	ESZOPICLONE

FDA Submissions

	ORIG	1	AP	2013-03-26
LABELING; Labeling	SUPPL	2	AP	2015-02-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-11-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-11-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	6	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91151
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESZOPICLONE","activeIngredients":"ESZOPICLONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESZOPICLONE","submission":"ESZOPICLONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESZOPICLONE","submission":"ESZOPICLONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ESZOPICLONE","submission":"ESZOPICLONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)