GLAND PHARMA LTD FDA Approval ANDA 213001

ANDA 213001

GLAND PHARMA LTD

FDA Drug Application

Application #213001

Documents

Letter2021-05-06

Application Sponsors

ANDA 213001GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION2.4GM/100ML0FOSCARNET SODIUMFOSCARNET SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-04-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213001
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSCARNET SODIUM","activeIngredients":"FOSCARNET SODIUM","strength":"2.4GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-21
        )

)

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