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FDA Drug Application 050587 by MERCK

Application Number050587
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/26/1985N       
AP010/8/1987SLR       
AP010/8/1987SLR       
AP010/29/1986SCS       
AP010/8/1987SLR       
AP01/25/1988SLR       
AP01/11/1988SLR       
AP05/20/1988SLR       
AP06/17/1988SCS       
AP012/12/1988SCS       
AP03/30/1989SCS       
AP08/24/1990SLR       
AP03/7/1994SLR       
AP08/26/1991SCS       
AP011/4/1993SLR       
AP01/14/1992SCS       
AP011/23/1992SLR       
AP07/17/1992SCP       
AP06/24/1994SLR       
AP09/12/1996SLR19147039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S039_PRIMAXIN.pdf 2/19/2008
AP011/19/1993SLR       
AP03/21/1995SLR19154041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S041_PRIMAXIN.pdf 2/19/2008
AP09/27/1994SCM       
AP03/10/1995SCS       
AP01/9/1997SLR20558045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050587_S045_PRIMAXIN.pdf 8/11/2008
AP09/19/1996SCM19148046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050587_S046_PRIMAXIN.pdf 2/19/2008
AP06/30/1997SLR       
AP04/8/1998SE5409048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50587sltr.pdf 4/8/1998
AP04/8/1998SE5410048   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50587s5-lbl.pdf 4/8/1998
AP07/24/1998SCP       
AP02/4/1999SLR       
AP07/13/1999SCM       
AP08/28/2000SLR18499052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/050587_S052_PRIMAXIN I.V..pdf 11/19/2007
AP011/30/2001SLR3898053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf 11/30/2001
AP07/23/2001SCS18498054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050587_S054_PRIMAXIN I.V..pdf 11/19/2007
AP08/29/2001SCS18497055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/050587_S055_PRIMAXIN I.V.pdf 11/19/2007
AP05/28/2002SCM       
AP03/4/2003SLR19141058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/050587_S058_PRIMAXIN.pdf 2/19/2008
AP03/4/2003SLR4235058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50587SLR058,50630SLR021ltr.pdf 3/10/2003
AP07/9/2002SCP20432059   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050587_S059_PRIMAXIN.pdf 8/1/2008
AP05/20/2004SLR8629061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf 5/26/2004
AP05/20/2004SLR19146061   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050587_S061_PRIMAXIN.pdf 2/19/2008
AP08/4/2006SLR14629064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050587s064, 050630s026LTR.pdf 8/7/2006
AP03/28/2008SLR19557065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf 4/1/2008
AP03/28/2008SLR19568065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s065, 050630s028ltr.pdf 4/2/2008
AP05/8/2008SLR21365070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050587s070, 050630s033ltr.pdf 12/19/2008
AP08/26/2009SLR23439072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050587s072,050630s035lbl.pdf 9/22/2009
AP08/26/2009SLR24068072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050587s072,050630s035ltr.pdf 11/20/2009
AP04/16/2012SLR32459073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050587s073lbl.pdf 4/16/2012
AP04/16/2012SLR32464073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050587s073ltr.pdf 4/18/2012
AP08/26/2014SCM       
AP012/16/2014SLR41287076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050587Orig1s076ltr.pdf 12/17/2014
AP012/16/2014SLR41288076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050587s076lbl.pdf 12/17/2014
AP02/19/2016SCM       
AP03/11/2016SCM       
AP010/3/2016SCM       




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