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FDA Drug Application 019384 by MERCK

Application Number019384
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/1986N28245000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf 3/15/2011
AP010/31/1986N36830000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246795.pdf 8/16/2013
AP03/18/1987SCS       
AP01/28/1988SLR       
AP01/28/1988SLR       
AP01/28/1988SLR       
AP011/26/1991SE2       
AP06/28/1988SCM       
AP011/26/1991SLR       
AP011/26/1991SE1       
AP011/26/1991SLR       
AP011/26/1991SLR       
AP011/26/1991SLR       
AP011/26/1991SLR       
AP04/17/1992SLR       
AP03/6/1992SLR       
AP05/6/1992SCM       
AP010/24/1994SE1       
AP06/29/1993SLR       
AP07/1/1994SLR19598024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S024_NOROXIN.pdf 4/4/2008
AP02/9/1998SLR       
AP011/29/1995SLR19599027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019384_S027_NOROXIN.pdf 4/4/2008
AP012/26/1995SCM       
AP09/12/1996SLR19600029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S029_NOROXIN.pdf 4/4/2008
AP07/18/1996SCP19601030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S030_NOROXIN.pdf 4/4/2008
AP01/15/1997SLR19602031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S031_NOROXIN.pdf 4/4/2008
AP06/18/1996SCM19603032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S032_NOROXIN.pdf 4/4/2008
AP07/18/1996SCS19604034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S034_NOROXIN.pdf 4/4/2008
AP012/6/1996SCP19605035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019384_S035_NOROXIN.pdf 4/4/2008
AP06/20/1997SLR19606036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019384_S036_NOROXIN.pdf 4/4/2008
AP04/16/2001SLR4909037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf 4/23/2001
AP04/16/2001SLR4910038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf 4/23/2001
AP04/16/2001SLR4913039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19384S38ltr.pdf 4/23/2001
AP07/23/2004SLR9860040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf 7/28/2004
AP07/23/2004SLR9871040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf 7/28/2004
AP07/23/2004SLR9861042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf 7/28/2004
AP07/23/2004SLR9872042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf 7/28/2004
AP07/23/2004SLR9862043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19384s040,042,043ltr.pdf 7/28/2004
AP07/23/2004SLR9873043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19384s040,042,043lbl.pdf 7/28/2004
AP05/16/2006SLR14130045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s045lbl.pdf 5/18/2006
AP05/16/2006SLR14140045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s045LTR.pdf 5/21/2006
AP09/22/2006SLR14973046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019384s046lbl.pdf 9/25/2006
AP09/22/2006SLR15020046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019384s046LTR.pdf 9/27/2006
AP03/14/2007SLR16037048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019384s048lbl.pdf 3/15/2007
AP09/23/2008SLR20891049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s049ltr.pdf 9/26/2008
AP09/23/2008SLR20939050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s049s050lbl.pdf 10/3/2008
AP010/3/2008SLR20958052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019384s052ltr.pdf 10/7/2008
AP010/3/2008SLR20994052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019384s052lbl.pdf 10/9/2008
AP02/12/2009SLR21839053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s053ltr.pdf 2/13/2009
AP04/27/2009SLR22413054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019384s054ltr.pdf 5/4/2009
AP04/27/2009SLR22499054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019384s054lbl.pdf 5/11/2009
AP06/10/2011SLR29218055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP02/25/2011SLR28022056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s056ltr.pdf 3/3/2011
AP02/25/2011SLR28066056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s056lbl.pdf 3/4/2011
AP09/8/2011SLR29979058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s058ltr.pdf 9/13/2011
AP05/27/2011SLR28990059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s059ltr.pdf 5/31/2011
AP010/18/2011SLR30350060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s060ltr.pdf 10/20/2011
AP010/18/2011SLR30509060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s060lbl.pdf 11/4/2011
AP09/16/2011SLR30046061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061lbl.pdf 9/20/2011
AP09/16/2011SLR30047061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019384s061MedG.pdf 9/20/2011
AP09/16/2011SLR30054061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019384s061ltr.pdf 9/21/2011
AP02/9/2012SLR31741062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s062lbl.pdf 2/10/2012
AP02/9/2012SLR31753062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s062ltr.pdf 2/13/2012
AP06/15/2012SLR32920063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019384s063ltr.pdf 6/18/2012
AP06/15/2012SLR32923063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019384s063lbl.pdf 6/18/2012
AP03/27/2013SLR35575065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s065ltr.pdf 3/29/2013
AP03/27/2013SLR35602065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s065lbl.pdf 4/1/2013
AP08/14/2013SLR36790066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019384s066lbl.pdf 8/15/2013
AP08/14/2013SLR36827066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019384Orig1s066ltr.pdf 8/16/2013
AP07/26/2016SLR46619067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019384s067lbl.pdf 7/26/2016
AP07/26/2016SLR46624067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019384Orig1s067ltr.pdf 7/26/2016




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