ANDA 091200

SUN PHARM INDS LTD

FDA Drug Application

Application #091200

Application Sponsors

ANDA 091200

SUN PHARM INDS LTD

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

2013-12-13

Submissions Property Types

ORIG

1

Null

17

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91200
            [companyName] => SUN PHARM INDS LTD
            [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
        )

)