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FDA Drug Application 017105 by RECORDATI RARE

Application Number017105
Application Type New Drug Application
Sponsor ApplicantRECORDATI RARE
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
AP06/23/1972N       
AP03/31/1975SCS       
AP011/13/1975SCS       
AP011/5/1975SLR       
AP09/10/1975SCS       
AP08/4/1976SCS       
AP08/4/1976SLR       
AP07/30/1976SCS       
AP03/18/1977SCS       
AP05/7/1976SCF       
AP03/10/1980SCM       
AP012/21/1976SCM       
AP01/4/1977SCM       
AP012/21/1976SCM       
AP010/20/1977SCF       
AP07/9/1979SCS       
AP010/21/1977SLR       
AP05/5/1978SCF       
AP04/17/1978SCF       
AP012/6/1978SCP       
AP06/7/1979SCS       
AP06/7/1979SCS       
AP06/7/1979SCM       
AP06/5/1979SCF       
AP05/31/1979SCS       
AP01/29/1981SES       
AP012/12/1979SLR       
AP07/14/1980SLR       
AP09/8/1980SCF       
AP010/28/1980SCS       
AP02/27/1984SCS       
AP06/16/1986SCS       
AP08/26/1985SCS       
AP08/29/1986SCS       
AP011/14/1986SCS       
AP01/8/1987SCS       
AP08/13/1987SCS       
AP02/7/2002SLR4021059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf 2/7/2002
AP02/7/2002SLR17136059   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S059_TRANXENE_AP.pdf 7/9/2007
AP011/5/1987SCP       
AP02/7/2002SLR4022062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf 2/7/2002
AP02/7/2002SLR17135062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S062_TRANXENE_AP.pdf 7/9/2007
AP011/8/1988SCS       
AP011/5/1996SCS       
AP08/4/1999SCS       
AP05/8/1998SCP       
AP08/28/2002SCS       
AP03/13/2003SLR4508070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17105slr070ltr.pdf 3/26/2003
AP03/13/2003SLR15226070   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017105_S070_Tranxene_APPROVAL_PACKAGE.pdf 10/25/2006
AP04/23/2009SLR22344075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf 4/28/2009
AP04/23/2009SLR22356075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017105s075ltr.pdf 4/29/2009
AP06/7/2010SLR25728076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf 6/14/2010
AP06/7/2010SLR25733076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017105s076ltr.pdf 6/15/2010
AP06/7/2010SLR25775076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076MedGuide.pdf 6/24/2010
AP07/19/2011SLR29567077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017105s077ltr.pdf 7/21/2011
AP02/3/2015SCM       




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