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FDA Drug Application 017862 by EUROHLTH INTL SARL

Application Number017862
Application Type New Drug Application
Sponsor ApplicantEUROHLTH INTL SARL
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
AP02/7/1979N24062000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176362.pdf 11/20/2009
AP010/1/1979SLR       
AP010/16/1979SCS       
AP01/22/1981SES       
AP012/28/1979SLR       
AP01/25/1980SCS       
AP06/28/1982SES       
AP010/8/1981SCS       
AP012/9/1981SCM       
AP02/19/1982SES       
AP05/27/1982SCM       
AP06/23/1982SCM       
AP09/8/1982SLR       
AP011/2/1982SCF       
AP011/12/1982SLR       
AP01/4/1983SCM       
AP04/13/1983SLR       
AP08/3/1984SCM       
AP06/14/1983SCM       
AP07/5/1983SES       
AP05/28/1987SE1       
AP03/12/1985SLR       
AP08/20/1985SLR       
AP010/21/1985SLR       
AP011/20/1985SCM       
AP05/28/1987SCP       
AP010/23/1986SLR       
AP04/17/1987SCS       
AP09/15/1987SLR       
AP09/12/1988SCM       
AP08/31/1992SCS       
AP02/22/1989SLR       
AP02/16/1990SCP       
AP05/31/1994SLR       
AP06/24/1996SLR       
AP06/1/2000SLR       
AP01/30/1998SCM       
AP03/9/1999SLR3127042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf 6/18/2001
AP08/27/1999SCM       
AP01/22/2001SCS       
AP01/22/2001SCS       
AP01/29/2001SCS       
AP011/7/2001SLR3124048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf 11/25/2002
AP04/19/2004SLR8432050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf 4/29/2004
AP04/19/2004SLR8433051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17862slr050,051ltr.pdf 4/29/2004
AP06/30/2009SLR22869061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017862s061ltr.pdf 7/6/2009
AP06/30/2009SLR22934061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017862s061lbl.pdf 7/9/2009
AP011/18/2010SLR27004063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017862s063ltr.pdf 11/22/2010
AP011/18/2010SLR27025063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063lbl.pdf 11/26/2010
AP011/18/2010SLR27026063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017862s063MedGuide.pdf 11/26/2010




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