AM REGENT FDA Approval NDA 021135

NDA 021135

AM REGENT

FDA Drug Application

Application #021135

Documents

Letter2000-11-13
Letter2003-06-08
Letter2005-10-19
Label2003-06-08
Label2005-06-21
Label2007-02-21
Label2011-06-29
Label2013-04-01
Label2012-09-25
Review2004-06-29
Letter2003-07-24
Letter2005-06-21
Letter2005-03-31
Letter2008-01-09
Letter2011-06-28
Letter2012-09-24
Label2004-06-29
Label2005-10-19
Label2007-12-14
Review2008-07-30
Label2017-11-29
Letter2017-12-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-12-20
Letter2018-12-21
Letter2020-09-14
Label2020-09-17
Letter2021-01-21
Label2021-04-01

Application Sponsors

NDA 021135AM REGENT

Marketing Status

Prescription001
Prescription002
Discontinued003
Prescription004
Discontinued005

Application Products

001INJECTABLE;INTRAVENOUSEQ 100MG BASE/5ML (EQ 20MG BASE/ML)1VENOFERIRON SUCROSE
002INJECTABLE;INTRAVENOUSEQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)1VENOFERIRON SUCROSE
003INJECTABLE;INTRAVENOUSEQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)0VENOFERIRON SUCROSE
004INJECTABLE;INTRAVENOUSEQ 200MG BASE/10ML (EQ 20MG BASE/ML)1VENOFERIRON SUCROSE
005INJECTABLE;INTRAVENOUSEQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)0VENOFERIRON SUCROSE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2000-11-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-01-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-12-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-07-26STANDARD
EFFICACY; EfficacySUPPL6AP2003-06-02STANDARD
EFFICACY; EfficacySUPPL8AP2005-06-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2005-03-29STANDARD
EFFICACY; EfficacySUPPL13AP2005-10-17UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2007-02-09N/A
LABELING; LabelingSUPPL17AP2007-12-03STANDARD
LABELING; LabelingSUPPL20AP2011-06-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2013-03-29STANDARD
EFFICACY; EfficacySUPPL24AP2012-09-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2016-03-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2014-06-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2015-05-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2016-06-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL31AP2016-05-27STANDARD
LABELING; LabelingSUPPL32AP2017-11-28STANDARD
LABELING; LabelingSUPPL35AP2018-12-19STANDARD
LABELING; LabelingSUPPL36AP2020-09-11STANDARD
LABELING; LabelingSUPPL37TA2020-07-21STANDARD

Submissions Property Types

SUPPL1Null23
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL10Null0
SUPPL20Null6
SUPPL23Null0
SUPPL24Null6
SUPPL26Null0
SUPPL27Null0
SUPPL28Null0
SUPPL29Null0
SUPPL31Null0
SUPPL32Null6
SUPPL35Null33
SUPPL36Null15
SUPPL37Null15

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21135
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"VENOFER","activeIngredients":"FERRIC OXYHYDROXIDE","strength":"EQ 100MG IRON\/5ML (EQ 20MG IRON\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VENOFER","activeIngredients":"FERRIC OXYHYDROXIDE","strength":"EQ 50MG IRON\/2.5ML (EQ 20MG IRON\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VENOFER","activeIngredients":"FERRIC OXYHYDROXIDE","strength":"EQ 75MG IRON\/3.75ML (EQ 20MG IRON\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VENOFER","activeIngredients":"FERRIC OXYHYDROXIDE","strength":"EQ 200MG IRON\/10ML (EQ 20MG IRON\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VENOFER","activeIngredients":"FERRIC OXYHYDROXIDE","strength":"EQ 65MG IRON\/3.25ML (EQ 20MG IRON\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/20\/2021","submission":"SUPPL-37","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021135Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2021","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/021135Orig1s037lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021135s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2018","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021135s035lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021135s032lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2017","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021135s032lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2013","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021135s023lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/21\/2012","submission":"SUPPL-24","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021135s024lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021135s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2007","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021135s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2007","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021135s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2007","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021135s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2005","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021135s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2005","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021135s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2002","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21135se2-005ltr.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/06\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21135lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VENOFER","submission":"FERRIC OXYHYDROXIDE","actionType":"EQ 100MG IRON\/5ML (EQ 20MG IRON\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VENOFER","submission":"FERRIC OXYHYDROXIDE","actionType":"EQ 50MG IRON\/2.5ML (EQ 20MG IRON\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VENOFER","submission":"FERRIC OXYHYDROXIDE","actionType":"EQ 75MG IRON\/3.75ML (EQ 20MG IRON\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VENOFER","submission":"FERRIC OXYHYDROXIDE","actionType":"EQ 200MG IRON\/10ML (EQ 20MG IRON\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VENOFER","submission":"FERRIC OXYHYDROXIDE","actionType":"EQ 65MG IRON\/3.25ML (EQ 20MG IRON\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2021-01-20
        )

)
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