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FDA Drug Application 020180 by MERCK

Application Number020180
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
AP06/19/1992N31028000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm 12/20/2011
AP08/20/1992SLR       
AP012/22/1992SCM       
AP012/22/1992SLR       
AP04/5/1993SCP       
AP09/1/1993SCM       
AP09/16/1993SCP       
AP05/18/1994SLR       
AP05/18/1994SLR       
AP012/30/1994SLR       
AP07/24/1996SCM14081010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020180_s010_ProscarTOC.cfm 5/10/2006
AP08/28/1996SLR6429011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020180s011_proscar_toc.cfm 8/7/2003
AP05/12/1997SCM4326013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20180-S013_PROSCAR.PDF 5/12/1997
AP05/16/1997SCS14080014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020180_s014_ProscarTOC.cfm 5/10/2006
AP03/20/1998SE54058015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20180-S015&16_PROSCAR.PDF 3/20/1998
AP03/20/1998SE14059016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20180-S015&16_PROSCAR.PDF 3/20/1998
AP012/19/1997SLR4325017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20180-S017_PROSCAR.PDF 12/19/1997
AP08/2/1999SLR20525018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020180_s018_PROSCAR 5MG.pdf 8/8/2008
AP01/17/2001SLR20465019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020180_s019_PROSCAR 5MG.pdf 8/4/2008
AP09/23/2003SLR6724020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr020ltr.pdf 9/30/2003
AP09/23/2003SLR17026020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_S020_PROSCAR_TABS_AP.pdf 7/6/2007
AP01/30/2001SLR20464022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020180_s022_PROSCAR 5MG.pdf 8/4/2008
AP010/28/2002SCS17378023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020180_S023_PROSCAR TABLETS.pdf 7/24/2007
AP011/26/2002SCS17379024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020180_S024_PROSCAR TABLETS.pdf 7/24/2007
AP06/26/2003SLR17057025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_S025_PROSCAR_TABS_AP.pdf 7/6/2007
AP06/26/2003SLR6046025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr025ltr.pdf 7/6/2003
AP04/12/2004SE88343026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf 4/14/2004
AP04/12/2004SE88372026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180se8-026ltr.pdf 4/20/2004
AP04/12/2004SE817375026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020180_S026_PROSCAR TABLETS.pdf 7/24/2007
AP09/9/2003SLR14063027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020180_s027_ProscarTOC.cfm 5/8/2006
AP09/9/2003SLR6649027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20180slr027ltr.pdf 9/25/2003
AP09/9/2003SLR6684027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20180slr027_proscar_lbl.pdf 9/25/2003
AP04/23/2004SLR17376029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020180_S029_PROSCAR TABLETS.pdf 7/24/2007
AP04/23/2004SLR8441029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20180slr029ltr.pdf 4/29/2004
AP04/23/2004SLR8484029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20180slr029_proscar_lbl.pdf 5/4/2004
AP03/23/2010SLR25128033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s033lbl.pdf 3/26/2010
AP03/23/2010SLR25133033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s033ltr.pdf 3/29/2010
AP06/10/2011SLR29221035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP010/4/2010SLR26607037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s037lbl.pdf 10/4/2010
AP010/4/2010SLR26614037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020180s037ltr.pdf 10/7/2010
AP06/9/2011SLR29095039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020180s039ltr.pdf 6/10/2011
AP06/9/2011SLR29096039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020180s039lbl.pdf 6/10/2011
AP04/11/2012SLR32388040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf 4/11/2012
AP04/11/2012SLR32413040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf 4/12/2012
AP04/11/2012SLR32414041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf 4/12/2012
AP04/11/2012SLR32389041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf 4/11/2012
AP04/11/2012SLR32390042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf 4/11/2012
AP04/11/2012SLR32415042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020180s040,s041,s042ltr.pdf 4/12/2012
AP01/16/2013SLR34898043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020180Orig1s043ltr.pdf 1/22/2013
AP01/16/2013SLR34921043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020180s043lbl.pdf 1/22/2013
AP03/11/2014SLR38772044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020180Orig1s044ltr.pdf 3/13/2014
AP03/11/2014SLR38789044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf 3/13/2014
AP07/6/2015SCM       




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