MEDA PHARMS FDA Approval NDA 022371

NDA 022371

MEDA PHARMS

FDA Drug Application

Application #022371

Documents

Review2009-08-31

Application Sponsors

NDA 022371MEDA PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001SPRAY, METERED;NASAL0.1%0ASTEPROAZELASTINE HYDROCHRLORIDE
002SPRAY, METERED;NASAL0.15%0ASTEPROAZELASTINE HYDROCHRLORIDE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)ORIG1AP2009-08-31STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

MEDA PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22371
            [companyName] => MEDA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ASTEPRO","activeIngredients":"AZELASTINE HYDROCHRLORIDE","strength":"0.1%","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ASTEPRO","activeIngredients":"AZELASTINE HYDROCHRLORIDE","strength":"0.15%","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ASTEPRO","submission":"AZELASTINE HYDROCHRLORIDE","actionType":"0.1%","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ASTEPRO","submission":"AZELASTINE HYDROCHRLORIDE","actionType":"0.15%","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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