NDA 022124

NYCOMED US INC

FDA Drug Application

Application #022124

Documents

• Letter: 2007-11-26
• Label: 2007-11-26
• Review: 2009-11-12
• Summary Review: 2009-11-12
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 022124

NYCOMED US INC

Marketing Status

• Prescription: 001

Application Products

001

SPRAY; NASAL

50MCG

0

OMNARIS

CICLESONIDE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2007-11-21

STANDARD

CDER Filings

NYCOMED US INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22124
            [companyName] => NYCOMED US INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMNARIS","activeIngredients":"CICLESONIDE","strength":"50MCG","dosageForm":"SPRAY; NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/21\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022124lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMNARIS","submission":"CICLESONIDE","actionType":"50MCG","submissionClassification":"SPRAY; NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-11-21
        )

)