Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INTRAMUSCULAR | 10MG/0.5ML | 0 | RYLAZE | ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-07-15 | STANDARD |
Submissions Property Types
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
)
)