EAGLE PHARMS FDA Approval NDA 208194

NDA 208194

EAGLE PHARMS

FDA Drug Application

Application #208194

Documents

Letter2015-12-09
Letter2016-06-24
Label2015-12-08
Review2016-06-27
Letter2016-06-24
Label2016-08-02
Label2016-06-27
Label2017-02-10
Letter2017-02-13
Review2018-02-15
Review2018-02-15
Label2018-07-31
Letter2018-08-03
Letter2019-10-10
Label2019-10-15
Letter2019-11-13
Label2019-12-12
Label2021-10-15
Letter2021-10-19

Application Sponsors

NDA 208194EAGLE PHARMS

Marketing Status

Prescription001

Application Products

001SOLUTION;IV (INFUSION)100MG/4ML (25MG/ML)1BENDEKABENDAMUSTINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2015-12-07STANDARD
LABELING; LabelingSUPPL2AP2016-06-23STANDARD
UNKNOWN; SUPPL3AP2016-09-23UNKNOWN
UNKNOWN; SUPPL4AP2017-02-06STANDARD
LABELING; LabelingSUPPL5AP2017-02-09STANDARD
LABELING; LabelingSUPPL13AP2018-07-30STANDARD
LABELING; LabelingSUPPL19AP2019-10-08STANDARD
LABELING; LabelingSUPPL20AP2019-11-08STANDARD
LABELING; LabelingSUPPL24AP2021-10-14STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null6
SUPPL5Orphan5
SUPPL13Null7
SUPPL19Null15
SUPPL20Null6
SUPPL24Null7

CDER Filings

EAGLE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208194
            [companyName] => EAGLE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDEKA","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/4ML (25MG\/ML)","dosageForm":"SOLUTION;IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/14\/2021","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208194s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208194s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208194s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208194s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208194s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208194s001s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/07\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/208194s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/208194s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/208194Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/208194Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/14\/2021","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208194s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208194Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208194s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208194Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208194s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208194Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208194s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208194Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"02\/09\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208194s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208194Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/06\/2017","submission":"SUPPL-4","supplementCategories":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208194Orig1s004.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2016","submission":"SUPPL-3","supplementCategories":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208194Orig1s003.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208194s001s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208194Orig1s001,s002ltr.pdf\"}]","notes":">"},{"actionDate":"06\/23\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208194Orig1s001,s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-10-14
        )

)
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