AM REGENT FDA Approval NDA 203565

NDA 203565

AM REGENT

FDA Drug Application

Application #203565

Documents

Letter2013-07-29
Review2013-09-04
Label2013-07-30
Summary Review2013-09-04
Label2018-01-30
Letter2018-01-30
Label2018-10-26
Letter2018-10-30
Letter2020-02-20
Label2020-02-20
Letter2020-09-14
Label2020-09-15
Letter2021-02-12
Label2021-02-22
Letter2021-04-30
Label2021-05-04
Letter2021-08-05
Label2021-09-03
Label2021-11-22
Letter2021-11-23
Label2022-07-19
Letter2022-07-20

Application Sponsors

NDA 203565AM REGENT

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INTRAVENOUS750MG IRON/15ML (50MG IRON/ML)1INJECTAFERFERRIC CARBOXYMALTOSE
002SOLUTION;INTRAVENOUS500MG IRON/10ML (50MG IRON/ML)1INJECTAFERFERRIC CARBOXYMALTOSE
003SOLUTION;INTRAVENOUS1GM IRON/20ML (50MG IRON/ML)1INJECTAFERFERRIC CARBOXYMALTOSE
004SOLUTION;INTRAVENOUS100MG IRON/2ML (50MG IRON/ML)1INJECTAFERFERRIC CARBOXYMALTOSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2013-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2015-12-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2015-11-16STANDARD
EFFICACY; EfficacySUPPL5AP2018-01-26PRIORITY
LABELING; LabelingSUPPL8AP2018-10-25STANDARD
LABELING; LabelingSUPPL9AP2020-02-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2020-10-08N/A
LABELING; LabelingSUPPL13AP2020-09-11STANDARD
EFFICACY; EfficacySUPPL14AP2021-04-28STANDARD
EFFICACY; EfficacySUPPL16AP2021-11-19STANDARD
LABELING; LabelingSUPPL17AP2021-08-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2022-02-04STANDARD

Submissions Property Types

ORIG1Null40
SUPPL3Null0
SUPPL4Null0
SUPPL5Null6
SUPPL8Null7
SUPPL9Null15
SUPPL13Null15
SUPPL14Null6
SUPPL16Null15
SUPPL17Null15

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203565
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"INJECTAFER","activeIngredients":"FERRIC CARBOXYMALTOSE","strength":"750MG IRON\/15ML (50MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INJECTAFER","activeIngredients":"FERRIC CARBOXYMALTOSE","strength":"500MG IRON\/10ML (50MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INJECTAFER","activeIngredients":"FERRIC CARBOXYMALTOSE","strength":"1GM IRON\/20ML (50MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"INJECTAFER","activeIngredients":"FERRIC CARBOXYMALTOSE","strength":"100MG IRON\/2ML (50MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/19\/2021","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203565Orig1s016_CORRECTED_lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203565Orig1s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2021","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203565s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2020","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203565Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203565s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203565s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203565s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203565s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203565s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/25\/2013","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\\\/2013\\\/203565s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203565s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203565Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203565Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/04\/2021","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203565Orig1s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/203565Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"11\/19\/2021","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203565Orig1s016_CORRECTED_lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/203565Orig1s016_CORRECTED_ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2021","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/203565s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/203565Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"09\/11\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203565s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203565Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"10\/08\/2020","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203565Orig1s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203565Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"02\/19\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203565s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203565Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"10\/25\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203565s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203565Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203565s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203565Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/16\/2015","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/16\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-11-19
        )

)
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