NDA 205580

EAGLE PHARMS

FDA Drug Application

Application #205580

Documents

• Label: 2018-05-23
• Letter: 2018-05-23
• Label: 2018-12-13
• Review: 2019-03-25
• Letter: 2019-10-31
• Label: 2019-10-31
• Label: 2021-10-15
• Letter: 2021-10-19
• Letter: 2022-06-03
• Label: 2022-06-06

Application Sponsors

NDA 205580

EAGLE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;IV (INFUSION)

100MG/4ML (25MG/ML)

1

BELRAPZO

BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-05-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-08-31	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-10-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-10-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-06-02	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	7
SUPPL	6	Null	15
SUPPL	10	Null	7
SUPPL	12	Null	15

CDER Filings

EAGLE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205580
            [companyName] => EAGLE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BELRAPZO","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-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205580s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/30\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205580s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205580s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205580s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205580s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/15\/2018","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\\\/2018\\\/205580s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205580s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/205580Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/14\/2021","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205580s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/205580Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"10\/30\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205580s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205580Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"08\/31\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205580s002lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2021-10-14
        )

)