ANDA 206483

ORIENT PHARMA CO LTD

FDA Drug Application

Application #206483

Application Sponsors

ANDA 206483

ORIENT PHARMA CO LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	1.25MG	0	GLYBURIDE	GLYBURIDE
002	TABLET;ORAL	2.5MG	0	GLYBURIDE	GLYBURIDE
003	TABLET;ORAL	5MG	0	GLYBURIDE	GLYBURIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB1
002	Prescription	AB1
003	Prescription	AB1

CDER Filings

ORIENT PHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206483
            [companyName] => ORIENT PHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYBURIDE","activeIngredients":"GLYBURIDE","strength":"1.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLYBURIDE","activeIngredients":"GLYBURIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLYBURIDE","activeIngredients":"GLYBURIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-22
        )

)