JAZZ PHARMS INC FDA Approval NDA 212690

NDA 212690

JAZZ PHARMS INC

FDA Drug Application

Application #212690

Documents

Label2020-07-22
Letter2020-07-22

Application Sponsors

NDA 212690JAZZ PHARMS INC

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL0.5MG/ML2XYWAVCALCIUM;MAGNESIUM;POTASSIUM;SODIUM OXYBATES

FDA Submissions

UNKNOWN; ORIG1AP2020-07-21PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

JAZZ PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212690
            [companyName] => JAZZ PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYWAV","activeIngredients":"CALCIUM;MAGNESIUM;POTASSIUM;SODIUM OXYBATES","strength":"0.5MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"07\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212690s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212690s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212690Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-21
        )

)

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