GLAND PHARMA LTD FDA Approval ANDA 204205

ANDA 204205

GLAND PHARMA LTD

FDA Drug Application

Application #204205

Application Sponsors

ANDA 204205GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/ML0METOPROLOL TARTRATEMETOPROLOL TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2014-08-27
LABELING; LabelingSUPPL4AP2021-11-16STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204205
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOPROLOL TARTRATE","activeIngredients":"METOPROLOL TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-08-27
        )

)

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