AJANTA PHARMA LTD FDA Approval ANDA 212890

ANDA 212890

AJANTA PHARMA LTD

FDA Drug Application

Application #212890

Application Sponsors

ANDA 212890AJANTA PHARMA LTD

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;ORAL50MG/ML0VALGANCICLOVIR HYDROCHLORIDEVALGANCICLOVIR HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-01-13STANDARD
LABELING; LabelingSUPPL4AP2022-08-22STANDARD
LABELING; LabelingSUPPL11AP2022-08-22STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7
SUPPL11Null7

TE Codes

001PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212890
            [companyName] => AJANTA PHARMA 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":"01\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-13
        )

)

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