ANDA 215693

ORIENT PHARMA

FDA Drug Application

Application #215693

Application Sponsors

ANDA 215693

ORIENT PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

EZETIMIBE

EZETIMIBE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ORIENT PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215693
            [companyName] => ORIENT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EZETIMIBE","activeIngredients":"EZETIMIBE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-13
        )

)