CADILA FDA Approval ANDA 205974

ANDA 205974

CADILA

FDA Drug Application

Application #205974

Application Sponsors

ANDA 205974CADILA

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICAL5%0ACYCLOVIRACYCLOVIR

FDA Submissions

UNKNOWN; ORIG1AP2019-03-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205974
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR","activeIngredients":"ACYCLOVIR","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)

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