ANDA 091264

HETERO LABS LTD III

FDA Drug Application

Application #091264

Application Sponsors

ANDA 091264

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2012-06-29
LABELING; Labeling	SUPPL	2	AP	2013-01-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-11-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-09-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-06-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-06-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	15
SUPPL	10	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91264
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOCETIRIZINE DIHYDROCHLORIDE","submission":"LEVOCETIRIZINE DIHYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)