ANDA 078351

MYLAN PHARMS INC

FDA Drug Application

Application #078351

Application Sponsors

ANDA 078351

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

5MG

0

DESLORATADINE

DESLORATADINE

FDA Submissions

	ORIG	1	AP	2012-02-10
LABELING; Labeling	SUPPL	4	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78351
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESLORATADINE","activeIngredients":"DESLORATADINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESLORATADINE","submission":"DESLORATADINE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)