Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021409
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SINGULAIR | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/26/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21409ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-409_Singulair.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/22/2021 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020829Orig1s074, 020830Orig1s076, 021409Orig1s052ltr.pdf | |
| 04/29/2020 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/20829Orig1s073,20830Orig1s075,21409Orig1s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020829Orig1s073, 020830Orig1s075, 021409Orig1s051ltr.pdf | |
| 08/09/2019 | SUPPL-50 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020829s072,020830s074,021409s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020829Orig1s072, 020830Orig1s074, 021409Orig1s050ltr.pdf | |
| 12/21/2018 | SUPPL-49 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020829Orig1s070s071,020830Orig1s072s073,021409Orig1s048s049Ltr.pdf | |
| 12/21/2018 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020829Orig1s070s071,020830Orig1s072s073,021409Orig1s048s049Ltr.pdf | |
| 12/13/2016 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020829Orig1s069,020830Orig1s071,021409Orig1s047ltr.pdf | |
| 11/26/2014 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf | |
| 12/30/2013 | SUPPL-43 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf | |
| 03/21/2013 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf | |
| 09/27/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf | |
| 10/18/2012 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf | |
| 12/16/2011 | SUPPL-37 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf | |
| 03/26/2012 | SUPPL-36 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021409s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf | |
| 04/27/2011 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf | |
| 08/10/2010 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf | |
| 04/26/2010 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021409s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf | |
| 08/19/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf | |
| 01/27/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf | |
| 04/24/2008 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021409s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf | |
| 04/21/2008 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf | |
| 03/07/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf | |
| 12/08/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf | |
| 05/19/2006 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf | |
| 06/27/2005 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf | |
| 04/13/2007 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf | |
| 05/26/2005 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf | |
| 11/30/2005 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf | |
| 07/27/2005 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf | |
| 12/29/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/15/2004 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf | |
| 12/19/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021409_S007_SINGULAIR_TABLETS_AP.pdf | |
| 10/02/2003 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf | |
| 12/31/2002 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409se1-003_singulair_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21409se1-003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/22/2021 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf | |
| 04/29/2020 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/20829Orig1s073,20830Orig1s075,21409Orig1s075lbl.pdf | |
| 04/29/2020 | SUPPL-51 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/20829Orig1s073,20830Orig1s075,21409Orig1s075lbl.pdf | |
| 08/09/2019 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020829s072,020830s074,021409s050lbl.pdf | |
| 08/09/2019 | SUPPL-50 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020829s072,020830s074,021409s050lbl.pdf | |
| 12/21/2018 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf | |
| 12/21/2018 | SUPPL-49 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf | |
| 12/21/2018 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf | |
| 12/13/2016 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf | |
| 11/26/2014 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf | |
| 12/30/2013 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf | |
| 12/30/2013 | SUPPL-43 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf | |
| 03/21/2013 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf | |
| 10/18/2012 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf | |
| 09/27/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf | |
| 03/26/2012 | SUPPL-36 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021409s036lbl.pdf | |
| 12/16/2011 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf | |
| 12/16/2011 | SUPPL-37 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf | |
| 04/27/2011 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf | |
| 08/10/2010 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf | |
| 04/26/2010 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021409s029lbl.pdf | |
| 08/19/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf | |
| 01/27/2009 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf | |
| 04/24/2008 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021409s026lbl.pdf | |
| 04/21/2008 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf | |
| 03/07/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf | |
| 04/13/2007 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf | |
| 12/08/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf | |
| 05/19/2006 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf | |
| 11/30/2005 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf | |
| 07/27/2005 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf | |
| 06/27/2005 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf | |
| 05/26/2005 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf | |
| 11/15/2004 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf | |
| 12/19/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf | |
| 10/02/2003 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf | |
| 12/31/2002 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409se1-003_singulair_lbl.pdf | |
| 07/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409lbl.pdf |
SINGULAIR
GRANULE;ORAL; EQ 4MG BASE/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 203438 | AJANTA PHARMA LTD |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 213471 | AUROBINDO PHARMA LTD |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 202906 | DR REDDYS LABS LTD |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | No | AB | 210431 | TORRENT |
| SINGULAIR | MONTELUKAST SODIUM | EQ 4MG BASE/PACKET | GRANULE;ORAL | Prescription | Yes | AB | 021409 | ORGANON |