LAURUS LABS LTD FDA Approval ANDA 214030

ANDA 214030

LAURUS LABS LTD

FDA Drug Application

Application #214030

Application Sponsors

ANDA 214030LAURUS LABS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORALEQ 25MG BASE0TENOFOVIR ALAFENAMIDE FUMARATETENOFOVIR ALAFENAMIDE FUMARATE

FDA Submissions

UNKNOWN; ORIG1TA2022-03-11STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

LAURUS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214030
            [companyName] => LAURUS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR ALAFENAMIDE FUMARATE","activeIngredients":"TENOFOVIR ALAFENAMIDE FUMARATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-11
        )

)

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