GLAND PHARMA LTD FDA Approval ANDA 215654

ANDA 215654

GLAND PHARMA LTD

FDA Drug Application

Application #215654

Application Sponsors

ANDA 215654GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 4MG PHOSPHATE/ML0DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215654
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE SODIUM PHOSPHATE","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 4MG PHOSPHATE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-04
        )

)

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