ANDA 075896

SUN PHARM INDUSTRIES

FDA Drug Application

Application #075896

Documents

• Review: 2007-11-19
• Letter: 2004-11-08

Application Sponsors

ANDA 075896

SUN PHARM INDUSTRIES

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	2.5MG	0	FELODIPINE	FELODIPINE
002	TABLET, EXTENDED RELEASE;ORAL	5MG	0	FELODIPINE	FELODIPINE
003	TABLET, EXTENDED RELEASE;ORAL	10MG	0	FELODIPINE	FELODIPINE

FDA Submissions

	ORIG	1	AP	2004-11-02
LABELING; Labeling	SUPPL	13	AP	2013-02-13	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-02-13	STANDARD

Submissions Property Types

SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75896
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"FELODIPINE","activeIngredients":"FELODIPINE","strength":"2.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FELODIPINE","activeIngredients":"FELODIPINE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FELODIPINE","activeIngredients":"FELODIPINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FELODIPINE","submission":"FELODIPINE","actionType":"2.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FELODIPINE","submission":"FELODIPINE","actionType":"5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FELODIPINE","submission":"FELODIPINE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)