ANDA 090335

MYLAN PHARMS INC

FDA Drug Application

Application #090335

Application Sponsors

ANDA 090335

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
002	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

	ORIG	1	AP	2010-06-01
LABELING; Labeling	SUPPL	3	AP	2012-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	3	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90335
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GABAPENTIN","submission":"GABAPENTIN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)