Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020830
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SINGULAIR | MONTELUKAST SODIUM | EQ 5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | AB | Yes | Yes |
| SINGULAIR | MONTELUKAST SODIUM | EQ 4MG BASE | TABLET, CHEWABLE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/22/2021 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s0760,021409s052lbl.pdf | |
| 04/29/2020 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/20829Orig1s073,20830Orig1s075,21409Orig1s075lbl.pdf | |
| 04/29/2020 | SUPPL-75 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/20829Orig1s073,20830Orig1s075,21409Orig1s075lbl.pdf | |
| 08/09/2019 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020829s072,020830s074,021409s050lbl.pdf | |
| 08/09/2019 | SUPPL-74 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020829s072,020830s074,021409s050lbl.pdf | |
| 12/21/2018 | SUPPL-73 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf | |
| 12/21/2018 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf | |
| 12/21/2018 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf | |
| 12/13/2016 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf | |
| 11/26/2014 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf | |
| 12/30/2013 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf | |
| 03/21/2013 | SUPPL-66 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf | |
| 10/18/2012 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf | |
| 09/27/2012 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf | |
| 03/26/2012 | SUPPL-61 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020830s061lbl.pdf | |
| 12/16/2011 | SUPPL-62 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf | |
| 12/16/2011 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf | |
| 04/27/2011 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf | |
| 08/10/2010 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf | |
| 04/26/2010 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020830s053lbl.pdf | |
| 08/19/2009 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/2009/020829s051_020830s052_021409s028lbl.pdf | |
| 01/27/2009 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf | |
| 04/24/2008 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020830s050lbl.pdf | |
| 04/21/2008 | SUPPL-49 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf | |
| 03/07/2008 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf | |
| 04/13/2007 | SUPPL-38 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf | |
| 12/08/2006 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf | |
| 05/19/2006 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf | |
| 11/30/2005 | SUPPL-36 | 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-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf | |
| 06/27/2005 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf | |
| 05/26/2005 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf | |
| 12/29/2004 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s032,20830s034,21409s011lbl.pdf | |
| 11/15/2004 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf | |
| 12/19/2003 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf | |
| 11/05/2003 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf | |
| 10/02/2003 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf | |
| 12/31/2002 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf | |
| 11/23/2001 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf | |
| 03/03/2000 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_prntlbl.pdf |