ANDA 204800

YUNG SHIN PHARM

FDA Drug Application

Application #204800

Application Sponsors

ANDA 204800

YUNG SHIN PHARM

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

UNKNOWN;

ORIG

1

AP

2019-04-29

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204800
            [companyName] => YUNG SHIN PHARM
            [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":"04\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-29
        )

)