SUN PHARM INDS LTD FDA Approval ANDA 210814

ANDA 210814

SUN PHARM INDS LTD

FDA Drug Application

Application #210814

Application Sponsors

ANDA 210814SUN PHARM INDS LTD

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2020-11-02STANDARD

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210814
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AFATINIB","activeIngredients":"AFATINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-02
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.