LAURUS FDA Approval ANDA 213541

ANDA 213541

LAURUS

FDA Drug Application

Application #213541

Application Sponsors

ANDA 213541LAURUS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL600MG;200MG;300MG0EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

LAURUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213541
            [companyName] => LAURUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"600MG;200MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-22
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.