NDA 211962

XELLIA PHARMS APS

FDA Drug Application

Application #211962

Documents

• Label: 2019-02-19
• Letter: 2019-02-21
• Review: 2019-08-23
• Letter: 2020-09-04
• Label: 2020-09-08
• Label: 2021-02-01
• Letter: 2021-02-01
• Letter: 2021-06-01
• Label: 2021-06-02

Application Sponsors

NDA 211962

XELLIA PHARMS APS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	SOLUTION;INTRAVENOUS	EQ 500MG BASE/100ML	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	EQ 1GM BASE/200ML	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
003	SOLUTION;INTRAVENOUS	EQ 1.5GM BASE/300ML	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
004	SOLUTION;INTRAVENOUS	EQ 2GM BASE/400ML	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
005	SOLUTION;INTRAVENOUS	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
006	SOLUTION;INTRAVENOUS	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
007	SOLUTION;INTRAVENOUS	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2019-02-15	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2020-09-03	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2021-05-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-01-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7
SUPPL	9	Null	15
SUPPL	11	Null	15

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211962
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/100ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/200ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1.5GM BASE\/300ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 2GM BASE\/400ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 750MG BASE\/150ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1.25GM BASE\/250ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1.75GM BASE\/350ML (EQ 5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/28\/2021","submission":"SUPPL-9","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211962s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211962s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211962s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211962s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211962s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211962Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211962Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/29\/2021","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211962s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211962Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"05\/28\/2021","submission":"SUPPL-9","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211962s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211962Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211962s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211962Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-05-28
        )

)