ANDA 090868

MYLAN PHARMS INC

FDA Drug Application

Application #090868

Documents

• Other Important Information from FDA: 2011-05-26

Application Sponsors

ANDA 090868

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	5MG	0	SIMVASTATIN	SIMVASTATIN
002	TABLET;ORAL	10MG	0	SIMVASTATIN	SIMVASTATIN
003	TABLET;ORAL	20MG	0	SIMVASTATIN	SIMVASTATIN
004	TABLET;ORAL	40MG	0	SIMVASTATIN	SIMVASTATIN
005	TABLET;ORAL	80MG	0	SIMVASTATIN	SIMVASTATIN

FDA Submissions

	ORIG	1	AP	2010-06-08
LABELING; Labeling	SUPPL	3	AP	2012-01-11
LABELING; Labeling	SUPPL	4	AP	2012-05-01
LABELING; Labeling	SUPPL	5	AP	2016-11-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90868
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SIMVASTATIN","activeIngredients":"SIMVASTATIN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SIMVASTATIN","submission":"SIMVASTATIN","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)