ANDA 076285

SUN PHARM INDS LTD

FDA Drug Application

Application #076285

Documents

• Letter: 2006-06-27
• Other Important Information from FDA: 2011-05-26

Application Sponsors

ANDA 076285

SUN PHARM INDS LTD

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	2006-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2006-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2006-12-20
LABELING; Labeling	SUPPL	4	AP	2006-12-20
LABELING; Labeling	SUPPL	9	AP	2008-06-18
LABELING; Labeling	SUPPL	13	AP	2009-10-05

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	13	Null	7

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76285
            [companyName] => SUN PHARM INDS LTD
            [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
        )

)