ANDA 078359

SUN PHARM INDS

FDA Drug Application

Application #078359

Application Sponsors

ANDA 078359

SUN PHARM INDS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

DESLORATADINE

DESLORATADINE

FDA Submissions

	ORIG	1	AP	2010-11-16
LABELING; Labeling	SUPPL	3	AP	2019-10-22	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-10-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78359
            [companyName] => SUN PHARM INDS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESLORATADINE","activeIngredients":"DESLORATADINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESLORATADINE","submission":"DESLORATADINE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)