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FDA Drug Application 050630 by MERCK

Application Number050630
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
AP012/14/1990N       
AP08/26/1991SCS       
AP011/4/1993SLR       
AP011/4/1993SLR       
AP011/23/1992SLR       
AP011/23/1992SLR       
AP06/24/1994SLR       
AP010/2/1996SLR20567009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050630_S009_PRIMAXIN.pdf 8/11/2008
AP09/27/1994SCM       
AP01/9/1997SLR20557011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S011_PRIMAXIN.pdf 8/11/2008
AP04/27/1995SCS       
AP06/30/1997SLR20556014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050630_S014_PRIMAXIN.pdf 8/11/2008
AP02/4/1999SLR3900015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50638S15_Primaxin.pdf 2/4/1999
AP04/10/2000SCS       
AP011/30/2001SLR3899017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf 11/30/2001
AP08/29/2001SCS       
AP05/28/2002SCM19144019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050630_S019_PRIMAXIN.pdf 2/19/2008
AP03/4/2003SLR4236021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50587SLR058,50630SLR021ltr.pdf 3/10/2003
AP03/4/2003SLR19140021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050630_S021_PRIMAXIN.pdf 2/19/2008
AP05/20/2004SLR8628023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf 5/26/2004
AP05/20/2004SLR19145023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050630_S023_PRIMAXIN.pdf 2/19/2008
AP08/4/2006SLR14628026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050587s064, 050630s026LTR.pdf 8/7/2006
AP03/22/2007SLR16119027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050630s027LTR.pdf 3/31/2007
AP03/22/2007SLR16135027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050630s027lbl.pdf 3/31/2007
AP03/28/2008SLR19558028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf 4/1/2008
AP03/28/2008SLR19569028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065, 050630s028ltr.pdf 4/2/2008
AP05/8/2008SLR21366033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070, 050630s033ltr.pdf 12/19/2008
AP08/26/2009SLR23440035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf 9/22/2009
AP08/26/2009SLR24136035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050587s072,050630s035ltr.pdf 11/25/2009




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