HAINAN POLY FDA Approval ANDA 215846

ANDA 215846

HAINAN POLY

FDA Drug Application

Application #215846

Documents

Letter2022-09-07

Application Sponsors

ANDA 215846HAINAN POLY

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;INTRAVENOUS10MG/50ML (0.2MG/ML)0SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE
002SOLUTION;INTRAVENOUS20MG/100ML (0.2MG/ML)0SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE
003SOLUTION;INTRAVENOUS50MG/100ML (0.5MG/ML)0SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

002PrescriptionAP
003PrescriptionAP

CDER Filings

HAINAN POLY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215846
            [companyName] => HAINAN POLY
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"10MG\/50ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"20MG\/100ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"50MG\/100ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-26
        )

)

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