NDA 208114

JAZZ PHARMS INC

FDA Drug Application

Application #208114

Documents

• Summary Review: 2016-05-10
• Letter: 2016-04-04
• Label: 2016-03-30
• Review: 2016-05-10

Application Sponsors

NDA 208114

JAZZ PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

200MG/2.5ML (80MG/ML)

1

DEFITELIO

DEFIBROTIDE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2016-03-30

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

JAZZ PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208114
            [companyName] => JAZZ PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFITELIO","activeIngredients":"DEFIBROTIDE SODIUM","strength":"200MG\/2.5ML (80MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/30\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208114Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208114Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208114Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208114Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208114Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-03-30
        )

)