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FDA Drug Application 018140 by EUROHLTH INTL SARL

Application Number018140
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/25/1980N       
AP09/9/1980SLR       
AP02/2/1981SCE       
AP09/5/1997SE13668003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018140ap_s003.pdf 10/5/1997
AP06/14/1983SCP       
AP02/14/1984SCS       
AP02/14/1984SCM       
AP04/24/1987SCM       
AP04/13/1987SLR       
AP03/19/1996SLR       
AP06/13/1989SCM       
AP03/19/1996SLR       
AP03/19/1996SLR       
AP011/3/1989SCM       
AP01/2/1991SCM       
AP06/26/1991SCM       
AP08/18/1992SCP       
AP06/3/1993SCS       
AP09/29/1993SCP       
AP09/29/1993SCP       
AP01/6/1995SCS       
AP03/8/1995SCE       
AP03/19/1996SLR       
AP09/26/1996SCM       
AP010/16/1998SCM       
AP011/4/1997SCM       
AP09/26/2000SLR       
AP012/12/2001SLR16189027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018140_S027_ATIVAN_INJECTION_AP.pdf 4/9/2007
AP011/29/2006SLR15415028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018140s028lbl.pdf 12/4/2006
AP011/29/2006SLR15581028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018140s028ltr.pdf 12/28/2006
AP04/18/2016SCM       
AP010/2/2015SCM       
AP05/27/2016SLR46201040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018140Orig1s040ltr.pdf 5/31/2016




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