Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021208
Company: ORGANON USA ORGANON
Company: ORGANON USA ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REMERON SOLTAB | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | Yes |
| REMERON SOLTAB | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | No |
| REMERON SOLTAB | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/12/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021208_remeron.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/18/2021 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf | |
| 04/29/2020 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415Orig1s034, s036; 021208Orig1s024, s026ltr.pdf | |
| 09/05/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021208s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020415Orig1s035, 021208Orig1s025ltr.pdf | |
| 04/29/2020 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415Orig1s034, s036; 021208Orig1s024, s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415Orig1s034, s036; 021208Orig1s024, s026ltr.pdf | |
| 12/30/2015 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021208s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf | |
| 07/18/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208Orig1s021ltr.pdf | |
| 07/08/2016 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021208s020lbl.pdf | |
| 03/04/2020 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s029, 021208s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415s029, 021208s019ltr.pdf | |
| 09/30/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf | |
| 05/14/2010 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf | |
| 05/14/2010 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf | |
| 12/23/2011 | SUPPL-12 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021208s012.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021208s012ltr.pdf | |
| 07/30/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019, 021208s010ltr.pdf | |
| 01/12/2005 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020415s018,021208s009ltr.pdf | |
| 06/01/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf |
| 11/14/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr006ltr.pdf |
| 05/21/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/18/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf | |
| 04/29/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf | |
| 04/29/2020 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf | |
| 03/04/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s029, 021208s019lbl.pdf | |
| 09/05/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021208s025lbl.pdf | |
| 07/08/2016 | SUPPL-20 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021208s020lbl.pdf | |
| 07/08/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021208s020lbl.pdf | |
| 12/30/2015 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021208s022lbl.pdf | |
| 07/18/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf | |
| 10/30/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016lbl.pdf | |
| 12/23/2011 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021208s012.pdf | |
| 05/14/2010 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf | |
| 05/14/2010 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf | |
| 07/30/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf | |
| 01/12/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf | |
| 01/12/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_prntlbl.pdf |
REMERON SOLTAB
TABLET, ORALLY DISINTEGRATING;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077376 | AUROBINDO PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205798 | SQUARE PHARMS |
| REMERON SOLTAB | MIRTAZAPINE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021208 | ORGANON USA ORGANON |
TABLET, ORALLY DISINTEGRATING;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077376 | AUROBINDO PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205798 | SQUARE PHARMS |
| REMERON SOLTAB | MIRTAZAPINE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021208 | ORGANON USA ORGANON |
TABLET, ORALLY DISINTEGRATING;ORAL; 45MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077376 | AUROBINDO PHARMA |
| MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205798 | SQUARE PHARMS |
| REMERON SOLTAB | MIRTAZAPINE | 45MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | Yes | AB | 021208 | ORGANON USA ORGANON |