ANDA 201653

SUN PHARM INDS LTD

FDA Drug Application

Application #201653

Application Sponsors

ANDA 201653

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2015-06-26
LABELING; Labeling	SUPPL	2	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-04-02	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-04-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-04-02	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201653
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/26\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/02\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-02
        )

)