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FDA Drug Application 020830 by MERCK

Application Number020830
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/1998N3251000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20830_Singulair.cfm 5/24/2001
AP02/20/1998N11450000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20830ltr.pdf 4/26/2005
AP02/20/1998N20590000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm 8/12/2008
AP02/12/1999SLR3253001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20830-s001_singulair.pdf 7/5/2001
AP04/2/1998SLR       
AP04/30/1998SLR       
AP09/18/1998SLR       
AP01/21/1999SCM       
AP012/1/1998SLR       
AP07/28/1999SCS       
AP03/3/2000SE13254008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830s008_Singulair.cfm 9/7/2001
AP03/3/2000SE15036008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_Approv.pdf 3/3/2000
AP03/3/2000SE15037008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830S008_Singulair_prntlbl.pdf 3/3/2000
AP010/17/2000SLR       
AP011/23/2001SE85446011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf 4/24/2003
AP011/23/2001SE83255011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20830s11ltr.pdf 11/23/2001
AP09/5/2000SCS       
AP08/2/2001SLR       
AP05/9/2001SCS       
AP010/26/2001SLR       
AP02/11/2002SCM       
AP012/31/2002SE19429020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf 6/17/2004
AP012/31/2002SE13250020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829se1-017,20830se1-020ltr.pdf 12/31/2002
AP010/7/2002SCP       
AP010/2/2003SLR17148026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf 7/9/2007
AP010/2/2003SLR9427026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf 6/17/2004
AP010/2/2003SLR6751026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf 10/9/2003
AP011/5/2003SLR6898028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf 11/13/2003
AP011/5/2003SLR6899028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr025,20830slr028ltr.pdf 11/13/2003
AP011/5/2003SLR17054028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020830_S028_SINGULAIR_AP.pdf 7/6/2007
AP012/19/2003SLR17048029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020830_S029_SINGULAIR_TABLETS_AP.pdf 7/6/2007
AP012/19/2003SLR7356029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf 12/23/2003
AP012/19/2003SLR7435029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf 12/29/2003
AP011/15/2004SLR10616033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf 11/17/2004
AP011/15/2004SLR10617033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf 11/17/2004
AP012/29/2004SLR10922034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21409s011ltr.pdf 1/11/2005
AP012/29/2004SLR10944034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s032,20830s034,21409s011lbl.pdf 1/11/2005
AP07/27/2005SE112345035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf 7/29/2005
AP07/27/2005SE112348035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf 7/29/2005
AP011/30/2005SE813202036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf 12/5/2005
AP011/30/2005SE813217036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf 12/6/2005
AP05/26/2005SLR11730037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf 5/27/2005
AP05/26/2005SLR11740037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf 5/27/2005
AP04/13/2007SE116241038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf 4/20/2007
AP04/13/2007SE116271038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf 4/20/2007
AP06/27/2005SLR11914039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf 6/29/2005
AP06/27/2005SLR11922039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf 6/29/2005
AP05/19/2006SLR14144040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf 5/22/2006
AP05/19/2006SLR14159040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf 5/22/2006
AP012/8/2006SLR15466041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf 12/14/2006
AP012/8/2006SLR15562041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf 12/28/2006
AP04/13/2007SLR16232043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf 4/20/2007
AP012/7/2007SLR18858047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020830s047ltr.pdf 1/9/2008
AP03/7/2008SLR19410048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf 3/11/2008
AP03/7/2008SLR19440048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf 3/13/2008
AP04/21/2008SLR19685049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf 4/22/2008
AP04/21/2008SLR19949049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf 6/5/2008
AP04/23/2008SLR19734050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf 4/28/2008
AP04/23/2008SLR19743050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020830s050lbl.pdf 4/29/2008
AP01/27/2009SLR21691051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf 1/30/2009
AP01/27/2009SLR21767051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf 2/4/2009
AP08/19/2009SLR23253052   http://www.accessdata.fda.gov/drugsatfda_docs/2009/020829s051_020830s052_021409s028lbl.pdf 8/28/2009
AP08/19/2009SLR23802052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf 11/10/2009
AP04/26/2010SLR25367053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020830s053lbl.pdf 4/28/2010
AP04/26/2010SLR25395053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf 4/29/2010
AP06/10/2011SLR29223055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP08/10/2010SLR26224056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf 8/16/2010
AP08/10/2010SLR26264056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf 8/19/2010
AP04/27/2011SLR28649059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf 4/29/2011
AP04/27/2011SLR28675059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf 5/3/2011
AP03/26/2012SE132194061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020830s061lbl.pdf 3/27/2012
AP03/26/2012SE132242061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf 3/28/2012
AP012/16/2011SLR31103062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf 12/20/2011
AP012/16/2011SLR31180062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf 12/21/2011
AP010/18/2012SLR34129063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf 10/22/2012
AP010/18/2012SLR34158063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf 10/22/2012
AP09/27/2012SLR33870064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf 9/28/2012
AP09/27/2012SLR33902064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf 10/2/2012
AP03/21/2013SLR35500066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf 3/22/2013
AP03/21/2013SLR35530066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf 3/26/2013
AP010/29/2014SCM       
AP012/30/2013SLR38204068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf 12/31/2013
AP012/30/2013SLR38207068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf 12/31/2013
AP011/26/2014SLR41115070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf 11/28/2014
AP011/26/2014SLR41321070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf 12/19/2014




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