ANDA 211089

ALKEM LABS LTD

FDA Drug Application

Application #211089

Documents

• Letter: 2019-09-30

Application Sponsors

ANDA 211089

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	5MG	0	VORTIOXETINE	VORTIOXETINE
002	TABLET;ORAL	10MG	0	VORTIOXETINE	VORTIOXETINE
003	TABLET;ORAL	15MG	0	VORTIOXETINE	VORTIOXETINE
004	TABLET;ORAL	20MG	0	VORTIOXETINE	VORTIOXETINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-08-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211089
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORTIOXETINE","activeIngredients":"VORTIOXETINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE","activeIngredients":"VORTIOXETINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE","activeIngredients":"VORTIOXETINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE","activeIngredients":"VORTIOXETINE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211089Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-21
        )

)