ANDA 211859

ZYDUS PHARMS USA INC

FDA Drug Application

Application #211859

Documents

• Letter: 2019-12-03

Application Sponsors

ANDA 211859

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET, CHEWABLE; 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

2019-11-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211859
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"10MG","dosageForm":"TABLET, CHEWABLE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"20MG","dosageForm":"TABLET, CHEWABLE, TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"30MG","dosageForm":"TABLET, CHEWABLE, TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211859Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-15
        )

)