GLAND PHARMA LTD FDA Approval ANDA 213917

ANDA 213917

GLAND PHARMA LTD

FDA Drug Application

Application #213917

Application Sponsors

ANDA 213917GLAND PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION2GM/50ML (40MG/ML)0MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE
002INJECTABLE;INJECTION4GM/100ML (40MG/ML)0MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-10STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213917
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"2GM\/50ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/100ML (40MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-10
        )

)

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