ANDA 203021

APOTEX INC

FDA Drug Application

Application #203021

Application Sponsors

ANDA 203021

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-05-22
LABELING; Labeling	SUPPL	2	AP	2015-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203021
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/20\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/12\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-01-20
        )

)