LUPIN ATLANTIS FDA Approval NDA 021695

NDA 021695

LUPIN ATLANTIS

FDA Drug Application

Application #021695

Documents

Letter2007-01-23
Letter2012-12-26
Label2004-12-03
Label2008-06-19
Label2013-10-22
Label2012-12-21
Label2015-09-04
Review2006-06-08
Letter2004-12-06
Letter2008-06-06
Letter2012-03-05
Letter2013-10-22
Label2012-03-06
Label2017-09-12
Letter2017-09-15
Label2018-05-22
Letter2018-05-24
Label2018-11-09
Letter2018-11-15
Label2019-02-13
Letter2019-02-27
Letter2019-05-16
Label2019-05-16
Label2021-06-04
Letter2021-06-07

Application Sponsors

NDA 021695LUPIN ATLANTIS

Marketing Status

Prescription001
Discontinued002
Prescription003
Prescription004
Prescription005

Application Products

001CAPSULE;ORAL43MG1ANTARA (MICRONIZED)FENOFIBRATE
002CAPSULE;ORAL87MG0ANTARA (MICRONIZED)FENOFIBRATE
003CAPSULE;ORAL130MG1ANTARA (MICRONIZED)FENOFIBRATE
004CAPSULE;ORAL30MG1ANTARA (MICRONIZED)FENOFIBRATE
005CAPSULE;ORAL90MG1ANTARA (MICRONIZED)FENOFIBRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2004-11-30STANDARD
LABELING; LabelingSUPPL6AP2008-06-03STANDARD
LABELING; LabelingSUPPL8AP2012-03-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2013-10-18STANDARD
LABELING; LabelingSUPPL10AP2012-12-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2014-09-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2015-08-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2016-11-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2016-11-29STANDARD
LABELING; LabelingSUPPL16AP2017-09-11STANDARD
LABELING; LabelingSUPPL17AP2018-05-18901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2019-02-04STANDARD
LABELING; LabelingSUPPL19AP2018-11-07STANDARD
LABELING; LabelingSUPPL20AP2019-05-15901 REQUIRED
LABELING; LabelingSUPPL22AP2021-06-03901 REQUIRED

Submissions Property Types

ORIG1Null31
SUPPL8Null7
SUPPL9Null0
SUPPL10Null15
SUPPL11Null0
SUPPL12Null0
SUPPL16Null6
SUPPL17Null6
SUPPL19Null7
SUPPL20Null7
SUPPL22Null7

TE Codes

001PrescriptionAB
003PrescriptionAB

CDER Filings

LUPIN ATLANTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21695
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANTARA (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"43MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ANTARA (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"87MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ANTARA (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"130MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ANTARA (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANTARA (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"90MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021695s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2019","submission":"SUPPL-18","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021695s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2018","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021695s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021695s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021695s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2015","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021695s012lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/18\/2013","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021695s009lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/19\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021695s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021695s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2008","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021695s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021695lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANTARA (MICRONIZED)","submission":"FENOFIBRATE","actionType":"43MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANTARA (MICRONIZED)","submission":"FENOFIBRATE","actionType":"87MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ANTARA (MICRONIZED)","submission":"FENOFIBRATE","actionType":"130MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANTARA (MICRONIZED)","submission":"FENOFIBRATE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANTARA (MICRONIZED)","submission":"FENOFIBRATE","actionType":"90MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-15
        )

)
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