ORGANON USA INC FDA Approval NDA 020415

NDA 020415

ORGANON USA INC

FDA Drug Application

Application #020415

Documents

Letter2002-10-02
Letter2004-06-07
Letter2005-01-13
Letter2007-08-02
Letter2010-05-21
Letter2012-11-01
Letter2015-12-31
Label2005-01-13
Label2010-05-28
Label2010-05-28
Label2012-11-06
Label2016-08-01
Label2014-07-30
Label2015-12-31
Medication Guide2012-11-06
Letter2002-04-16
Letter2011-12-29
Letter2010-05-21
Letter2014-07-23
Label2007-07-31
Label2011-12-27
Review2004-09-08
Other Important Information from FDA2005-08-01
Review1996-06-14
Label2019-09-06
Medication Guide2019-09-06
Letter2019-09-06
Label2020-03-04
Letter2020-03-04
Letter2020-04-30
Letter2020-04-30
Label2020-04-30
Label2020-04-30
Medication Guide2020-04-30
Medication Guide2020-04-30
Label2021-11-19
Medication Guide2021-11-19

Application Sponsors

NDA 020415ORGANON USA INC

Marketing Status

Prescription001
Prescription002
Discontinued003

Application Products

001TABLET;ORAL15MG1REMERONMIRTAZAPINE
002TABLET;ORAL30MG1REMERONMIRTAZAPINE
003TABLET;ORAL45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1REMERONMIRTAZAPINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1996-06-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-11-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-03-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-04-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-05-11STANDARD
LABELING; LabelingSUPPL6AP2000-08-30STANDARD
LABELING; LabelingSUPPL7AP2000-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-07-19STANDARD
EFFICACY; EfficacySUPPL9AP2002-04-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-01-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-11-20STANDARD
LABELING; LabelingSUPPL15AP2002-09-30STANDARD
LABELING; LabelingSUPPL16AP2004-06-01STANDARD
LABELING; LabelingSUPPL18AP2005-01-12STANDARD
LABELING; LabelingSUPPL19AP2007-07-30STANDARD
LABELING; LabelingSUPPL22AP2011-12-27STANDARD
LABELING; LabelingSUPPL23AP2010-05-14UNKNOWN
LABELING; LabelingSUPPL24AP2010-05-14UNKNOWN
LABELING; LabelingSUPPL26AP2012-10-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2012-12-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2014-09-30STANDARD
LABELING; LabelingSUPPL29AP2020-03-04STANDARD
LABELING; LabelingSUPPL30AP2016-07-08STANDARD
LABELING; LabelingSUPPL31AP2014-07-18901 REQUIRED
LABELING; LabelingSUPPL32AP2015-12-30STANDARD
LABELING; LabelingSUPPL34AP2020-04-29STANDARD
LABELING; LabelingSUPPL35AP2019-09-05STANDARD
LABELING; LabelingSUPPL36AP2020-04-29STANDARD
LABELING; LabelingSUPPL38AP2021-11-18STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL8Null0
SUPPL10Null0
SUPPL14Null0
SUPPL22Null7
SUPPL23Null31
SUPPL24Null6
SUPPL26Null6
SUPPL27Null0
SUPPL28Null0
SUPPL29Null15
SUPPL30Null6
SUPPL31Null6
SUPPL32Null7
SUPPL34Null7
SUPPL35Null7
SUPPL36Null15
SUPPL38Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ORGANON USA INC
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(
    [0] => Array
        (
            [ApplNo] => 20415
            [companyName] => ORGANON USA INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020415s034s036,021208s024s026lbl.pdf#page=23"]
            [products] => [{"drugName":"REMERON","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REMERON","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REMERON","activeIngredients":"MIRTAZAPINE","strength":"45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020415s034s036,021208s024s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2020","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020415s034s036,021208s024s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2020","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"09\/05\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020415s035lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-30","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020415s030lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020415s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2015","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020415s032lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/30\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020415s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2011","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020415s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020415s023s024.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020415s023s024.pdf\"}]","notes":""},{"actionDate":"07\/30\/2007","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020415s019,021208s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2005","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020415s018,021208s009lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REMERON","submission":"MIRTAZAPINE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMERON","submission":"MIRTAZAPINE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMERON","submission":"MIRTAZAPINE","actionType":"45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-29
        )

)
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