XELLIA PHARMS APS FDA Approval ANDA 204107

ANDA 204107

XELLIA PHARMS APS

FDA Drug Application

Application #204107

Application Sponsors

ANDA 204107XELLIA PHARMS APS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2015-12-28
LABELING; LabelingSUPPL3AP2020-08-19STANDARD
LABELING; LabelingSUPPL5AP2020-08-19STANDARD
LABELING; LabelingSUPPL11AP2021-09-20STANDARD

Submissions Property Types

ORIG1Null19
SUPPL3Null7
SUPPL5Null7
SUPPL11Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

XELLIA PHARMS APS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204107
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/19\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-19
        )

)

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