ORGANON USA INC FDA Approval NDA 021208

NDA 021208

ORGANON USA INC

FDA Drug Application

Application #021208

Documents

Letter2007-08-02
Letter2010-05-21
Letter2012-11-01
Letter2015-12-31
Label2001-01-12
Label2005-01-13
Label2010-05-28
Label2016-08-01
Label2015-12-31
Review2002-04-29
Other Important Information from FDA2005-08-01
Letter2001-01-12
Letter2003-07-24
Letter2004-06-07
Letter2005-01-13
Letter2012-01-03
Letter2010-05-21
Letter2014-07-23
Label2007-07-31
Label2012-01-26
Label2010-05-28
Label2012-11-06
Label2014-07-30
Label2019-09-06
Medication Guide2019-09-06
Letter2019-09-06
Label2020-03-04
Letter2020-03-04
Letter2020-04-30
Letter2020-04-30
Letter2020-04-30
Label2020-04-30
Medication Guide2020-04-30
Label2020-04-30
Medication Guide2020-04-30
Label2021-11-19
Medication Guide2021-11-19

Application Sponsors

NDA 021208ORGANON USA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL15MG1REMERON SOLTABMIRTAZAPINE
002TABLET, ORALLY DISINTEGRATING;ORAL30MG1REMERON SOLTABMIRTAZAPINE
003TABLET, ORALLY DISINTEGRATING;ORAL45MG1REMERON SOLTABMIRTAZAPINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2001-01-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-03-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-11-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-05-21STANDARD
LABELING; LabelingSUPPL6AP2002-11-14STANDARD
LABELING; LabelingSUPPL8AP2004-06-01STANDARD
LABELING; LabelingSUPPL9AP2005-01-12STANDARD
LABELING; LabelingSUPPL10AP2007-07-30STANDARD
LABELING; LabelingSUPPL12AP2011-12-23STANDARD
LABELING; LabelingSUPPL13AP2010-05-14UNKNOWN
LABELING; LabelingSUPPL14AP2010-05-14UNKNOWN
LABELING; LabelingSUPPL16AP2012-10-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2014-09-30STANDARD
LABELING; LabelingSUPPL19AP2020-03-04STANDARD
LABELING; LabelingSUPPL20AP2016-07-08STANDARD
LABELING; LabelingSUPPL21AP2014-07-18901 REQUIRED
LABELING; LabelingSUPPL22AP2015-12-30STANDARD
LABELING; LabelingSUPPL24AP2020-04-29STANDARD
LABELING; LabelingSUPPL25AP2019-09-05STANDARD
LABELING; LabelingSUPPL26AP2020-04-29STANDARD
LABELING; LabelingSUPPL28AP2021-11-18STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL12Null6
SUPPL13Null7
SUPPL14Null7
SUPPL16Null7
SUPPL18Null0
SUPPL19Null15
SUPPL20Null6
SUPPL21Null7
SUPPL22Null7
SUPPL24Null7
SUPPL25Null15
SUPPL26Null6
SUPPL28Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ORGANON USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21208
            [companyName] => ORGANON USA INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020415s035lbl.pdf#page=24"]
            [products] => [{"drugName":"REMERON SOLTAB","activeIngredients":"MIRTAZAPINE","strength":"15MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"REMERON SOLTAB","activeIngredients":"MIRTAZAPINE","strength":"30MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"REMERON SOLTAB","activeIngredients":"MIRTAZAPINE","strength":"45MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/29\/2020","submission":"SUPPL-26","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-24","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-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"09\/05\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021208s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021208s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021208s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2015","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021208s022lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/30\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021208s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021208s012.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021208s013s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2010","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021208s013s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2007","submission":"SUPPL-10","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-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020415s018,021208s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-208_Remeron_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"REMERON SOLTAB","submission":"MIRTAZAPINE","actionType":"15MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMERON SOLTAB","submission":"MIRTAZAPINE","actionType":"30MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"REMERON SOLTAB","submission":"MIRTAZAPINE","actionType":"45MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-29
        )

)
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