MACLEODS PHARMS LTD FDA Approval ANDA 214397

ANDA 214397

MACLEODS PHARMS LTD

FDA Drug Application

Application #214397

Application Sponsors

ANDA 214397MACLEODS PHARMS LTD

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2021-03-22STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214397
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-22
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.