JAZZ PHARMS FDA Approval BLA 761179

BLA 761179

JAZZ PHARMS

FDA Drug Application

Application #761179

Documents

Label2021-07-01
Letter2021-07-01

Application Sponsors

BLA 761179JAZZ PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAMUSCULAR10MG/0.5ML0RYLAZEASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-06-30STANDARD

Submissions Property Types

ORIG1Null2

CDER Filings

JAZZ PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761179
            [companyName] => JAZZ PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYLAZE","activeIngredients":"ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN","strength":"10MG\/0.5ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/30\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761179s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761179s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761179Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-30
        )

)

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