Documents
Application Sponsors
NDA 021208 | ORGANON USA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | 1 | REMERON SOLTAB | MIRTAZAPINE |
002 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | 1 | REMERON SOLTAB | MIRTAZAPINE |
003 | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | 1 | REMERON SOLTAB | MIRTAZAPINE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2001-01-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-03-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-11-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-04-03 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2002-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2002-11-14 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2004-06-01 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2005-01-12 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2007-07-30 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2011-12-23 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2010-05-14 | UNKNOWN |
LABELING; Labeling | SUPPL | 14 | AP | 2010-05-14 | UNKNOWN |
LABELING; Labeling | SUPPL | 16 | AP | 2012-10-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2014-09-30 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2020-03-04 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2016-07-08 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2014-07-18 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 22 | AP | 2015-12-30 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2020-04-29 | STANDARD |
LABELING; Labeling | SUPPL | 25 | AP | 2019-09-05 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2020-04-29 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2021-11-18 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 12 | Null | 6 |
SUPPL | 13 | Null | 7 |
SUPPL | 14 | Null | 7 |
SUPPL | 16 | Null | 7 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 15 |
SUPPL | 20 | Null | 6 |
SUPPL | 21 | Null | 7 |
SUPPL | 22 | Null | 7 |
SUPPL | 24 | Null | 7 |
SUPPL | 25 | Null | 15 |
SUPPL | 26 | Null | 6 |
SUPPL | 28 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
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
)
)