Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020415
Company: ORGANON USA INC
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 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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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-Patient Package Insert, 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-30 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.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
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-Patient Package Insert 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
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 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 076541 SUN PHARM INDS INC
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076119 TEVA
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076219 UPSHER SMITH LABS
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076312 WATSON LABS
REMERON MIRTAZAPINE 15MG TABLET;ORAL Prescription Yes AB 020415 ORGANON USA INC

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 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 076541 SUN PHARM INDS INC
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076119 TEVA
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076219 UPSHER SMITH LABS
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076312 WATSON LABS
REMERON MIRTAZAPINE 30MG TABLET;ORAL Prescription Yes AB 020415 ORGANON USA INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English