ANDA 210169

AIRIS PHARMA PVT LTD

FDA Drug Application

Application #210169

Application Sponsors

ANDA 210169

AIRIS PHARMA PVT LTD

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

50MG/ML

0

VALGANCICLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

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
        )

)