ANDA 201294

APOTEX CORP

FDA Drug Application

Application #201294

Documents

• Letter: 2012-08-06

Application Sponsors

ANDA 201294

APOTEX CORP

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-08-03
LABELING; Labeling	SUPPL	4	AP	2013-08-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-03-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-03-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201294
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201294Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-03-16
        )

)