ANDA 090753

PAR PHARM

FDA Drug Application

Application #090753

Application Sponsors

ANDA 090753

PAR PHARM

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

85MG; 500MG

0

SUMATRIPTAN; NAPROXEN SODIUM

SUMATRIPTAN; NAPROXEN SODIUM

FDA Submissions

ORIG

1

TA

2013-11-29

Submissions Property Types

ORIG

1

Null

3

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90753
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN; NAPROXEN SODIUM","activeIngredients":"SUMATRIPTAN; NAPROXEN SODIUM","strength":"85MG; 500MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUMATRIPTAN; NAPROXEN SODIUM","submission":"SUMATRIPTAN; NAPROXEN SODIUM","actionType":"85MG; 500MG","submissionClassification":"TABLET; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)