ANDA 040009

SUN PHARM INDS INC

FDA Drug Application

Application #040009

Documents

• Letter: 2004-06-07
• Review: 1998-12-30

Application Sponsors

ANDA 040009

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

40MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1998-12-30
LABELING; Labeling	SUPPL	2	AP	2002-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-11-19	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	15

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40009
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"40MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)