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FDA Drug Application 020829 by MERCK

Application Number020829
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/1998N327000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20829ltr.pdf 2/20/1998
AP02/20/1998N328000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20829lbl.pdf 2/20/1998
AP02/20/1998N329000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020829s000_SingulairTOC.cfm 2/20/1998
AP02/20/1998N20589000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm 8/12/2008
AP02/12/1999SLR3252001   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       
AP010/17/2000SLR       
AP09/5/2000SCS       
AP08/2/2001SLR5445012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20829s12lbl.pdf 4/24/2003
AP06/18/2001SCS       
AP010/26/2001SLR       
AP02/11/2002SCM       
AP012/31/2002SE14968017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf 4/7/2003
AP012/31/2002SE13249017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829se1-017,20830se1-020ltr.pdf 12/31/2002
AP07/11/2002SCS       
AP010/7/2002SCP       
AP010/2/2003SLR17149023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf 7/9/2007
AP010/2/2003SLR6750023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf 10/9/2003
AP010/2/2003SLR6780023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf 10/10/2003
AP011/5/2003SLR6897025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf 11/13/2003
AP011/5/2003SLR6900025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr025,20830slr028ltr.pdf 11/13/2003
AP011/5/2003SLR17055025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S025_SINGULAIR_TABLETS_AP.pdf 7/6/2007
AP012/19/2003SLR17049026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S026_SINGULAIR_TABLETS_AP.pdf 7/6/2007
AP012/19/2003SLR7355026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf 12/23/2003
AP012/19/2003SLR7434026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf 12/29/2003
AP011/15/2004SLR       
AP011/15/2004SLR10614031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf 11/17/2004
AP011/15/2004SLR10619031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf 11/17/2004
AP012/29/2004SLR10921032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21409s011ltr.pdf 1/11/2005
AP012/29/2004SLR10943032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s032,20830s034,21409s011lbl.pdf 1/11/2005
AP07/27/2005SE112346033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf 7/29/2005
AP07/27/2005SE112347033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf 7/29/2005
AP07/27/2005SE131783033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020829s033_020830s035_021409s012Approv.pdf 2/14/2012
AP011/30/2005SE813203034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf 12/5/2005
AP011/30/2005SE813218034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf 12/6/2005
AP05/26/2005SLR11731035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf 5/27/2005
AP05/26/2005SLR11741035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf 5/27/2005
AP04/13/2007SE116242036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf 4/20/2007
AP04/13/2007SE116272036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf 4/20/2007
AP06/27/2005SLR11913037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf 6/29/2005
AP06/27/2005SLR11923037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf 6/29/2005
AP05/19/2006SLR14145038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf 5/22/2006
AP05/19/2006SLR14160038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf 5/22/2006
AP012/8/2006SLR15467039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf 12/14/2006
AP012/8/2006SLR15563039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf 12/28/2006
AP04/13/2007SLR16234041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf 4/20/2007
AP04/13/2007SLR16235042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf 4/20/2007
AP04/13/2007SLR16233043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf 4/20/2007
AP03/7/2008SLR19409046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf 3/11/2008
AP03/7/2008SLR19415046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046lbl.pdf 3/11/2008
AP04/21/2008SLR19684047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf 4/22/2008
AP04/21/2008SLR19950047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf 6/5/2008
AP04/23/2008SLR19733048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf 4/28/2008
AP04/23/2008SLR19744048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s048lbl.pdf 4/29/2008
AP01/27/2009SLR21690049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf 1/30/2009
AP01/27/2009SLR21768049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf 2/4/2009
AP08/19/2009SLR23317051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf 9/15/2009
AP08/19/2009SLR23801051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf 11/10/2009
AP04/26/2010SLR25366052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s052lbl.pdf 4/28/2010
AP04/26/2010SLR25394052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf 4/29/2010
AP06/10/2011SLR29222054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP08/10/2010SLR26223055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf 8/16/2010
AP08/10/2010SLR26265055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf 8/19/2010
AP04/27/2011SLR28650057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf 4/29/2011
AP04/27/2011SLR28674057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf 5/3/2011
AP03/26/2012SE132196059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s059lbl.pdf 3/26/2012
AP03/26/2012SE132241059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf 3/28/2012
AP012/16/2011SLR31105060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf 12/20/2011
AP012/16/2011SLR31179060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf 12/21/2011
AP010/18/2012SLR34128061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf 10/22/2012
AP010/18/2012SLR34157061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf 10/22/2012
AP07/16/2012SLR33210062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s062ltr.pdf 7/17/2012
AP07/16/2012SLR33218062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s062lbl.pdf 7/18/2012
AP09/27/2012SLR33869063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf 9/28/2012
AP09/27/2012SLR33901063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf 10/2/2012
AP03/21/2013SLR35499065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf 3/22/2013
AP03/21/2013SLR35531065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf 3/26/2013
AP012/30/2013SLR38203066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf 12/31/2013
AP012/30/2013SLR38206066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf 12/31/2013
AP01/28/2014SCM       
AP011/26/2014SLR41116068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf 11/28/2014
AP011/26/2014SLR41322068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf 12/19/2014




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