Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021208
Company: ORGANON USA INC
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
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
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
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 LTD
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076901 IMPAX LABS INC
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 ZYDUS PHARMS USA INC
REMERON SOLTAB MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA INC

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 LTD
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076901 IMPAX LABS INC
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 ZYDUS PHARMS USA INC
REMERON SOLTAB MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA INC

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 LTD
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076901 IMPAX LABS INC
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 ZYDUS PHARMS USA INC
REMERON SOLTAB MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA INC

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