ANDA 202859

UNIMARK REMEDIES LTD

FDA Drug Application

Application #202859

Application Sponsors

ANDA 202859

UNIMARK REMEDIES LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-06-25	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2015-03-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-03-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-12-08	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

UNIMARK REMEDIES LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202859
            [companyName] => UNIMARK REMEDIES LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/08\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/20\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/20\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/25\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/20\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-08
        )

)