Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020415
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REMERON | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| REMERON | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | AB | Yes | No |
| REMERON | MIRTAZAPINE | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/14/1996 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020415Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/18/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf | |
| 04/29/2020 | SUPPL-36 | 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-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020415Orig1s035, 021208Orig1s025ltr.pdf | |
| 04/29/2020 | SUPPL-34 | 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 | |
| 12/30/2015 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf | |
| 07/18/2014 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient 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-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf | |
| 03/04/2020 | SUPPL-29 | 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-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf | |
| 05/14/2010 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf | |
| 05/14/2010 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf | |
| 12/27/2011 | SUPPL-22 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020415s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020415s022ltr.pdf | |
| 07/30/2007 | SUPPL-19 | 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-18 | 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-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf |
| 09/30/2002 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415slr015ltr.pdf |
| 11/20/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/2002 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415s9ltr.pdf |
| 07/19/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/11/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-415s003_Remeron.cfm |
| 11/07/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
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-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf | |
| 04/29/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf | |
| 04/29/2020 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf | |
| 03/04/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s029, 021208s019lbl.pdf | |
| 09/05/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf | |
| 07/08/2016 | SUPPL-30 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf | |
| 07/08/2016 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf | |
| 12/30/2015 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf | |
| 07/18/2014 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf | |
| 07/18/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf | |
| 07/18/2014 | SUPPL-31 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf | |
| 10/30/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf | |
| 12/27/2011 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020415s022lbl.pdf | |
| 05/14/2010 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf | |
| 05/14/2010 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf | |
| 07/30/2007 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf | |
| 01/12/2005 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf |
REMERON
TABLET;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;ORAL | Prescription | No | AB | 076219 | AIPING PHARM INC |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
| MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |
| REMERON | MIRTAZAPINE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 020415 | ORGANON |
TABLET;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;ORAL | Prescription | No | AB | 076219 | AIPING PHARM INC |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 077666 | APOTEX INC |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076921 | AUROBINDO |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076122 | MYLAN |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 216751 | PRASCO |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076541 | SUN PHARM INDS INC |
| MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | No | AB | 076119 | TEVA |
| REMERON | MIRTAZAPINE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 020415 | ORGANON |