ANDA 208279

GLENMARK PHARMS LTD

FDA Drug Application

Application #208279

Application Sponsors

ANDA 208279

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

10MG

0

TRETINOIN

TRETINOIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208279
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRETINOIN","activeIngredients":"TRETINOIN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-23
        )

)