ANDA 075556

SUN PHARM INDS LTD

FDA Drug Application

Application #075556

Documents

• Letter: 2000-08-22
• Letter: 2004-06-03

Application Sponsors

ANDA 075556

SUN PHARM INDS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	2.5MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
002	TABLET;ORAL	5MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
003	TABLET;ORAL	10MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE
004	TABLET;ORAL	20MG	0	ENALAPRIL MALEATE	ENALAPRIL MALEATE

FDA Submissions

	ORIG	1	AP	2000-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-10-01
LABELING; Labeling	SUPPL	5	AP	2016-04-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-04-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	7
SUPPL	6	Null	7

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75556
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENALAPRIL MALEATE","activeIngredients":"ENALAPRIL MALEATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ENALAPRIL MALEATE","submission":"ENALAPRIL MALEATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)