GLAND PHARMA LTD FDA Approval ANDA 216249

ANDA 216249

GLAND PHARMA LTD

FDA Drug Application

Application #216249

Application Sponsors

ANDA 216249GLAND PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUSEQ 25MG BASE/5ML (EQ 5MG BASE/ML)0ZINC SULFATEZINC SULFATE
002SOLUTION;INTRAVENOUSEQ 30MG BASE/10ML (EQ 3MG BASE/ML)0ZINC SULFATEZINC SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216249
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE","strength":"EQ 25MG BASE\/5ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZINC SULFATE","activeIngredients":"ZINC SULFATE","strength":"EQ 30MG BASE\/10ML (EQ 3MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-03
        )

)

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