ANDA 078353

ZYDUS PHARMS USA

FDA Drug Application

Application #078353

Application Sponsors

ANDA 078353

ZYDUS PHARMS USA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

5MG

0

DESLORATADINE

DESLORATADINE

FDA Submissions

ORIG

1

TA

2011-05-23

Submissions Property Types

ORIG

1

Null

0

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78353
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESLORATADINE","activeIngredients":"DESLORATADINE","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DESLORATADINE","submission":"DESLORATADINE","actionType":"5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)