PTS CONSULTING FDA Approval ANDA 209642

ANDA 209642

PTS CONSULTING

FDA Drug Application

Application #209642

Application Sponsors

ANDA 209642PTS CONSULTING

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION2GM/50ML (40MG/ML)0MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE
002INJECTABLE;INJECTION4GM/100ML (40MG/ML)0MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE
003INJECTABLE;INJECTION4GM/50ML (80MG/ML)0MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

PTS CONSULTING
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209642
            [companyName] => PTS CONSULTING
            [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"},{"drugName":"MAGNESIUM SULFATE IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"4GM\/50ML (80MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-08
        )

)

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