ANDA 078560

GLENMARK PHARMS LTD

FDA Drug Application

Application #078560

Documents

• Letter: 2015-06-29

Application Sponsors

ANDA 078560

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

EZETIMIBE

EZETIMIBE

FDA Submissions

ORIG

1

AP

2015-06-26

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78560
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EZETIMIBE","activeIngredients":"EZETIMIBE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EZETIMIBE","submission":"EZETIMIBE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)