AIRIS PHARMA PVT LTD FDA Approval ANDA 210169

ANDA 210169

AIRIS PHARMA PVT LTD

FDA Drug Application

Application #210169

Application Sponsors

ANDA 210169AIRIS PHARMA PVT LTD

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL50MG/ML0VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-02-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AIRIS PHARMA PVT LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210169
            [companyName] => AIRIS PHARMA PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALGANCICLOVIR HYDROCHLORIDE","activeIngredients":"VALGANCICLOVIR HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-17
        )

)

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