GLENMARK PHARMS LTD FDA Approval ANDA 203281

ANDA 203281

GLENMARK PHARMS LTD

FDA Drug Application

Application #203281

Application Sponsors

ANDA 203281GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL5MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL
002TABLET;ORAL20MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL
003TABLET;ORAL40MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL

FDA Submissions

UNKNOWN; ORIG1AP2017-05-25
LABELING; LabelingSUPPL2AP2022-08-29STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203281
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/25\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-25
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.