ANDA 209677

IMPAX

FDA Drug Application

Application #209677

Application Sponsors

ANDA 209677

IMPAX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

14MG

0

TERIFLUNOMIDE

TERIFLUNOMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-06-17	STANDARD
UNKNOWN;	ORIG	2	TA	2020-06-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

TE Codes

001

Prescription

AB

CDER Filings

IMPAX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209677
            [companyName] => IMPAX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"14MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/17\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-17
        )

)