ANDA 091263

L PERRIGO CO

FDA Drug Application

Application #091263

Documents

• Letter: 2011-11-08

Application Sponsors

ANDA 091263

L PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

2.5MG/5ML

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-10-27
LABELING; Labeling	SUPPL	4	AP	2015-04-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-07-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-07-10	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-07-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-07-10	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-07-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-07-10	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	7

TE Codes

001

Prescription

AA

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91263
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOCETIRIZINE DIHYDROCHLORIDE","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"2.5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOCETIRIZINE DIHYDROCHLORIDE","submission":"LEVOCETIRIZINE DIHYDROCHLORIDE","actionType":"2.5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)