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FDA Drug Application 021409 by MERCK

Application Number021409
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
AP07/26/2002N3247000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21409ltr.pdf 7/26/2002
AP07/26/2002N3248000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409lbl.pdf 7/26/2002
AP07/26/2002N10643000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-409_Singulair.cfm 11/22/2004
AP07/26/2002N20591000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm 8/12/2008
AP012/31/2002SE15077003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21409se1-003_singulair_lbl.pdf 4/9/2003
AP012/31/2002SE13246003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21409se1-003ltr.pdf 1/23/2003
AP010/2/2003SLR6752005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf 10/9/2003
AP010/2/2003SLR9428005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf 6/17/2004
AP010/2/2003SLR17147005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf 7/9/2007
AP012/19/2003SLR7357007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf 12/23/2003
AP012/19/2003SLR7436007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf 12/29/2003
AP012/19/2003SLR17047007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021409_S007_SINGULAIR_TABLETS_AP.pdf 7/6/2007
AP011/15/2004SLR10615010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf 11/17/2004
AP011/15/2004SLR10618010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf 11/17/2004
AP012/29/2004SLR       
AP07/27/2005SE112344012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf 7/29/2005
AP07/27/2005SE112349012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf 7/29/2005
AP011/30/2005SE813201014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf 12/5/2005
AP011/30/2005SE813216014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf 12/6/2005
AP05/26/2005SLR11729015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf 5/27/2005
AP05/26/2005SLR11739015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf 5/27/2005
AP04/13/2007SE116240016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf 4/20/2007
AP04/13/2007SE116270016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf 4/20/2007
AP06/27/2005SLR11915017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf 6/29/2005
AP06/27/2005SLR11921017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf 6/29/2005
AP05/19/2006SLR14143018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf 5/22/2006
AP05/19/2006SLR14158018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf 5/22/2006
AP012/8/2006SLR15465019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf 12/14/2006
AP012/8/2006SLR15561019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf 12/28/2006
AP03/7/2008SLR19411023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf 3/11/2008
AP03/7/2008SLR19439023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046,020830s048,021409s023lbl.pdf 3/13/2008
AP04/21/2008SLR19686025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf 4/22/2008
AP04/21/2008SLR19948025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf 6/5/2008
AP04/23/2008SLR19735026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf 4/28/2008
AP04/23/2008SLR19745026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021409s026lbl.pdf 4/29/2008
AP01/27/2009SLR21689027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf 1/30/2009
AP01/27/2009SLR21766027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf 2/4/2009
AP08/19/2009SLR23254028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf 8/28/2009
AP08/19/2009SLR23803028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf 11/10/2009
AP04/26/2010SLR25369029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021409s029lbl.pdf 4/28/2010
AP04/26/2010SLR25396029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf 4/29/2010
AP08/10/2010SLR26225031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf 8/16/2010
AP08/10/2010SLR26263031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf 8/19/2010
AP04/27/2011SLR28648034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf 4/29/2011
AP04/27/2011SLR28676034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf 5/3/2011
AP03/26/2012SE132192036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021409s036lbl.pdf 3/26/2012
AP03/26/2012SE132243036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf 3/28/2012
AP012/16/2011SLR31102037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf 12/20/2011
AP012/16/2011SLR31181037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf 12/21/2011
AP010/18/2012SLR34130039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf 10/22/2012
AP010/18/2012SLR34159039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf 10/22/2012
AP09/27/2012SLR33871040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf 9/28/2012
AP09/27/2012SLR33903040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf 10/2/2012
AP03/21/2013SLR35501042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf 3/22/2013
AP03/21/2013SLR35529042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf 3/26/2013
AP012/30/2013SLR38202043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf 12/31/2013
AP012/30/2013SLR38205043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf 12/31/2013
AP011/26/2014SLR41114045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf 11/28/2014
AP011/26/2014SLR41320045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf 12/19/2014




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