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FDA Drug Application 013217 by KING PHARMS

Application Number013217
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
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
AP08/13/1962N       
AP04/4/1977SCF       
AP02/26/1979SCE       
AP02/13/1980SLR       
AP04/15/1980SCM       
AP01/16/1981SLR       
AP01/16/1981SCM       
AP03/27/1984SCM       
AP03/27/1984SCP       
AP012/4/1985SLR       
AP05/31/1985SCS       
AP012/31/1985SCS       
AP02/26/1987SCM       
AP02/28/1989SCS       
AP07/27/1992SCP       
AP01/5/1995SCM       
AP03/27/1995SCP       
AP06/28/1995SCS       
AP07/7/1997SCS       
AP03/20/1997SCM       
AP04/13/1999SCS       
AP03/26/1998SCM       
AP04/13/1999SCS       
AP09/18/1998SCM       
AP08/30/2002SCF3259036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13217scf036LTR.pdf 8/30/2002
AP08/30/2002SCF3261036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/13217s036lbl.pdf 8/30/2002
AP05/4/2000SCS23300037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/013217_S037_SKELAXIN.pdf 9/14/2009
AP01/31/2001SCM23301040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013217_S040_SKELAXIN.pdf 9/14/2009
AP09/26/2001SCM23302041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013217_S041_SKELAXIN.pdf 9/14/2009
AP04/16/2002SCM23303043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217_S043_SKELAXIN.pdf 9/14/2009
AP06/20/2002SLR3257044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13217s044ltr_2.pdf 6/20/2002
AP06/20/2002SLR14077044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217s044_SkelexinTOC.cfm 5/10/2006
AP06/3/2002SCS23304045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013217_S045_SKELAXIN.pdf 9/14/2009
AP011/24/2006SLR15406046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/013217s046lbl.pdf 12/4/2006
AP011/24/2006SLR15425046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/013217s046ltr.pdf 12/4/2006
AP010/31/2008SLR21118053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013217s053ltr.pdf 11/3/2008
AP010/31/2008SLR34473053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013217s053lbl.pdf 11/27/2012
AP01/27/2014SCM       
AP09/29/2014SCM       
AP05/9/2016SCM       
AP010/7/2016SCM       




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