ANDA 211761

ASCEND LABORATORIES LLC

FDA Drug Application

Application #211761

Documents

• Letter: 2020-09-22

Application Sponsors

ANDA 211761

ASCEND LABORATORIES LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 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

2020-08-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ASCEND LABORATORIES LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211761
            [companyName] => ASCEND LABORATORIES LLC
            [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":"08\/21\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211761Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-21
        )

)