BLA 125359

JAZZ PHARMS INC

FDA Drug Application

Application #125359

Documents

• Letter: 2011-11-21
• Letter: 2014-03-11
• Letter: 2014-12-24
• Letter: 2016-03-31
• Label: 2011-11-18
• Label: 2016-03-30
• Label: 2014-03-10
• Label: 2015-03-27
• Review: 2011-12-28
• Summary Review: 2011-12-28
• Label: 2019-12-16
• Letter: 2019-12-17

Application Sponsors

BLA 125359

JAZZ PHARMS INC

Marketing Status

• Prescription: 001

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
        )

)