NDA 205004

FRESENIUS KABI USA

FDA Drug Application

Application #205004

Documents

• Label: 2017-11-07
• Letter: 2017-11-17
• Review: 2017-12-14
• Label: 2018-07-13
• Letter: 2018-07-16
• Review: 2019-02-01
• Label: 2021-09-21
• Letter: 2021-09-22

Application Sponsors

NDA 205004

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

3.5MG/VIAL

0

BORTEZOMIB

BORTEZOMIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-11-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-07-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-09-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	6

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205004
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BORTEZOMIB","activeIngredients":"BORTEZOMIB","strength":"3.5MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/12\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205004s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205004s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205004s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205004s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205004Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/205004Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/12\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205004s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205004Orig1s002Ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/205004Orig1s002.pdf\"}]","notes":">"}]
            [actionDate] => 2018-07-12
        )

)