ANDA 090229

SYNTHON PHARMS

FDA Drug Application

Application #090229

Documents

• Letter: 2010-12-03

Application Sponsors

ANDA 090229

SYNTHON PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2011-06-27
LABELING; Labeling	SUPPL	4	AP	2011-06-30
LABELING; Labeling	SUPPL	7	AP	2015-06-29
LABELING; Labeling	SUPPL	8	AP	2015-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-06-29	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2017-04-07	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2021-03-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-03-18	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	7
SUPPL	13	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SYNTHON PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90229
            [companyName] => SYNTHON PHARMS
            [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
        )

)