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FDA Drug Application 014879 by EUROHLTH INTL SARL

Application Number014879
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/1965N       
AP04/5/1976SLR       
AP011/1/1976SCS       
AP09/11/1979SCS       
AP05/3/1976SCS       
AP04/6/1977SCS       
AP06/20/1977SCM       
AP02/15/1979SCM       
AP02/15/1979SLR       
AP011/27/1978SLR       
AP011/30/1978SCS       
AP02/15/1980SCS       
AP09/24/1981SCS       
AP08/6/1982SCS       
AP08/6/1982SLR       
AP08/6/1982SOA       
AP08/6/1982SLR       
AP03/4/1982SCM       
AP09/17/1985SPD       
AP03/2/1983SCS       
AP05/16/1984SCS       
AP07/24/1986SCS       
AP06/18/1986SCS       
AP01/14/1987SLR       
AP01/14/1987SLR       
AP05/31/1988SCS       
AP01/13/1989SCS       
AP02/13/1998SCM       
AP08/23/2001SLR1741036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14879s36ltr.pdf 8/23/2001
AP03/29/2006SLR13851037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014879s037ltr.pdf 4/5/2006
AP04/16/2004SLR8386040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14879slr040ltr.pdf 4/20/2004
AP04/16/2004SLR8474040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf 5/3/2004
AP03/17/2005SLR11281044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14879s044ltr.pdf 3/23/2005
AP03/17/2005SLR11282044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf 3/23/2005
AP03/17/2005SLR17239044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/014879_S044_Dopram Injection_APPROVAL_ PACKAGE.pdf 7/9/2007




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