ANDA 208195

YUNG SHIN PHARM

FDA Drug Application

Application #208195

Application Sponsors

ANDA 208195

YUNG SHIN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.5MG	0	ENTECAVIR	ENTECAVIR
002	TABLET;ORAL	1MG	0	ENTECAVIR	ENTECAVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208195
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-10
        )

)