ANDA 211734

MANKIND PHARMA

FDA Drug Application

Application #211734

Documents

• Letter: 2019-05-24

Application Sponsors

ANDA 211734

MANKIND PHARMA

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	APREMILAST	APREMILAST
002	TABLET;ORAL	20MG	0	APREMILAST	APREMILAST
003	TABLET;ORAL	30MG	0	APREMILAST	APREMILAST

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-04-18

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MANKIND PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211734
            [companyName] => MANKIND PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/18\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211734Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-18
        )

)