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FDA Drug Application 017037 by EUROHLTH INTL SARL

Application Number017037
Application Type New Drug Application
Sponsor ApplicantEUROHLTH INTL SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/22/1972N       
AP03/5/1984SLR       
AP03/24/1975SLR       
AP04/23/1975SCS       
AP09/4/1975SLR       
AP09/4/1975SLR       
AP09/4/1975SLR       
AP09/4/1975SDS       
AP09/4/1975SLR       
AP09/4/1975SLR       
AP01/9/1976SCS       
AP05/28/1976SCS       
AP09/8/1976SCS       
AP09/8/1976SCS       
AP09/8/1976SCS       
AP09/8/1976SCS       
AP010/19/1976SLR       
AP010/19/1976SDS       
AP02/17/1977SCS       
AP05/26/1977SCP       
AP04/26/1977SCP       
AP05/26/1977SCS       
AP08/2/1977SDS       
AP01/3/1978SCM       
AP012/14/1977SCF       
AP012/14/1977SLR       
AP04/27/1978SLR       
AP04/27/1978SCS       
AP012/14/1977SLR       
AP012/14/1977SCM       
AP012/14/1977SLR       
AP07/31/1978SLR       
AP07/31/1978SCM       
AP08/4/1978SCM       
AP07/31/1978SLR       
AP08/4/1978SCS       
AP010/4/1978SLR       
AP01/16/1979SLR       
AP01/16/1979SCS       
AP01/16/1979SCS       
AP03/6/1979SCS       
AP09/25/1979SCF       
AP01/21/1980SCS       
AP05/22/1981SLR       
AP011/20/1981SLR       
AP06/4/1982SCM       
AP08/18/1982SCP       
AP010/6/1982SCM       
AP09/13/1983SCS       
AP06/10/1983SCS       
AP09/5/1983SLR       
AP012/21/1983SLR       
AP08/2/1984SCF       
AP010/11/1984SLR       
AP010/11/1984SLR       
AP01/21/1986SCF       
AP05/13/1985SLR       
AP08/29/1985SCP       
AP08/29/1985SCP       
AP04/7/1986SCP       
AP010/10/1985SCM       
AP01/30/1986SLR       
AP04/29/1987SLR       
AP09/23/1986SCM       
AP04/29/1987SCE       
AP03/10/1987SCM       
AP04/24/1987SCS       
AP07/2/1987SLR       
AP07/2/1987SLR       
AP09/16/1987SLR       
AP010/14/1987SLR       
AP06/28/1989SLR       
AP06/20/1989SLR       
AP06/20/1989SLR       
AP09/27/1989SCE       
AP04/23/1991SLR       
AP02/9/1993SCS       
AP03/5/1996SCS       
AP04/24/1997SCM       
AP06/23/1998SLR       
AP02/20/1998SCS       
AP09/30/1999SLR       
AP05/13/1999SCS       
AP02/15/2000SCS       
AP05/1/2000SCS       
AP05/26/2000SCS       
AP05/26/2000SCS       
AP05/31/2000SCS       
AP011/16/2000SCP       
AP08/31/2001SCS       
AP02/5/2002SLR       
AP07/15/2002SCE       
AP011/22/2002SCP       
AP011/21/2002SCP       
AP011/25/2002SCE       
AP011/22/2002SCE       
AP09/2/2005SCS12727154   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf 9/7/2005
AP09/2/2005SCS12732154   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf 9/7/2005
AP09/2/2005SCF12728155   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf 9/7/2005
AP09/2/2005SCF12730155   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf 9/7/2005
AP09/2/2005SCP12731156   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf 9/7/2005
AP09/2/2005SCP12729156   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf 9/7/2005
AP010/4/2006SLR15056158   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf 10/5/2006
AP010/4/2006SLR15100158   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017037s158LTR.pdf 10/13/2006
AP012/14/2007SLR18667161   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf 12/21/2007
AP012/14/2007SLR18835161   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017037s161ltr.pdf 1/9/2008
AP02/17/2009SLR21874162   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s162ltr.pdf 2/19/2009
AP010/1/2009SLR23597165   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf 10/16/2009
AP010/1/2009SLR23753165   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s165ltr.pdf 11/9/2009
AP02/23/2011SLR27977168   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s168ltr.pdf 2/28/2011
AP02/23/2011SLR28038168   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf 3/4/2011
AP012/23/2011SLR31294169   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s169ltr.pdf 12/29/2011
AP012/23/2011SLR31530169   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf 1/26/2012
AP08/27/2013SCM       
AP01/9/2014SCM       
AP01/15/2014SCM       
AP01/5/2015SCM       
AP012/2/2015SCM       
AP012/23/2015SCM       
AP010/30/2015SCM       




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