CADILA FDA Approval ANDA 204313

ANDA 204313

CADILA

FDA Drug Application

Application #204313

Application Sponsors

ANDA 204313CADILA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL200MG0ACYCLOVIRACYCLOVIR

FDA Submissions

UNKNOWN; ORIG1AP2016-03-25

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204313
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-25
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.