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FDA Drug Application 018565 by EUROHLTH INTL SARL

Application Number018565
Application Type New Drug Application
Sponsor ApplicantEUROHLTH INTL SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/18/1984N       
AP08/22/1985SLR       
AP07/19/1991SCS       
AP07/19/1991SLR       
AP05/3/1989SLR       
AP04/28/1994SLR       
AP02/12/1997SCS       
AP04/17/1998SCS       
AP06/14/1999SCS       
AP012/7/2001SLR       
AP06/26/2003SLR6038010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18565slr010ltr.pdf 7/6/2003
AP05/27/2004SLR8836012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18565slr012ltr.pdf 6/1/2004
AP05/27/2004SLR22591012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/018565s012lbl.pdf 5/19/2009
AP06/6/2005SLR11772014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018565s014ltr.pdf 6/8/2005
AP06/6/2005SLR11783014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018565s014lbl.pdf 6/8/2005
AP010/1/2010SLR26606020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018565s020ltr.pdf 10/5/2010
AP010/1/2010SLR26632020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018565s020lbl.pdf 10/12/2010
AP06/6/2016SCM       




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