ANDA 078488

BRECKENRIDGE

FDA Drug Application

Application #078488

Application Sponsors

ANDA 078488

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

5MG/5ML

0

CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-10-06
LABELING; Labeling	SUPPL	5	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-03-03	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AA

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78488
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CETIRIZINE HYDROCHLORIDE","submission":"CETIRIZINE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)