ANDA 091377

XELLIA PHARMS APS

FDA Drug Application

Application #091377

Application Sponsors

ANDA 091377

XELLIA PHARMS APS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2015-09-09

Submissions Property Types

ORIG

1

Null

19

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91377
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VANCOMYCIN HYDROCHLORIDE","submission":"VANCOMYCIN HYDROCHLORIDE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VANCOMYCIN HYDROCHLORIDE","submission":"VANCOMYCIN HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)