ANDA 200831

WATSON LABS INC

FDA Drug Application

Application #200831

Application Sponsors

ANDA 200831

WATSON LABS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

EZETIMIBE

EZETIMIBE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2017-06-12

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200831
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EZETIMIBE","activeIngredients":"EZETIMIBE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-12
        )

)