Documents
Application Sponsors
BLA 125359 | JAZZ PHARMS INC | |
Marketing Status
Application Products
001 | INJECTABLE; INJECTION | 10,000IU | 0 | ERWINAZE | asparaginase Erwinia chrysanthemi |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2011-11-18 | PRIORITY |
LABELING; Labeling | SUPPL | 70 | AP | 2014-03-07 | STANDARD |
LABELING; Labeling | SUPPL | 80 | AP | 2014-06-13 | STANDARD |
EFFICACY; Efficacy | SUPPL | 85 | AP | 2014-12-19 | STANDARD |
LABELING; Labeling | SUPPL | 88 | AP | 2016-03-29 | STANDARD |
LABELING; Labeling | SUPPL | 98 | AP | 2019-12-13 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 25 |
SUPPL | 85 | Null | 6 |
SUPPL | 88 | Null | 7 |
SUPPL | 98 | Null | 6 |
CDER Filings
JAZZ PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 125359
[companyName] => JAZZ PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ERWINAZE","activeIngredients":"asparaginase Erwinia chrysanthemi","strength":"10,000IU","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-98","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125359s098lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2016","submission":"SUPPL-88","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125359s088lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2014","submission":"SUPPL-85","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125359s085lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-70","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125359s070lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125359lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/18\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125359lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125359s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125359_erwinaze_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125359Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-98","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125359s098lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125359Orig1s098ltr.pdf\"}]","notes":">"},{"actionDate":"03\/29\/2016","submission":"SUPPL-88","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125359s088lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125359Orig1s088ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2014","submission":"SUPPL-85","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125359s085lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125359Orig1s085ltr.pdf\"}]","notes":">"},{"actionDate":"06\/13\/2014","submission":"SUPPL-80","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/07\/2014","submission":"SUPPL-70","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125359s070lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125359Orig1s070ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-12-13
)
)