Back to FDA Applications sponsored by XSPIRE

FDA Drug Application 017604 by XSPIRE

Application Number017604
Application Type New Drug Application
Sponsor ApplicantXSPIRE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/16/1976N24021000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088655.pdf 11/19/2009
AP09/23/1976SCE       
AP04/1/1977SCS       
AP010/24/1978SCE       
AP010/15/1980SES       
AP010/15/1980SCS       
AP08/9/1983SLR       
AP05/6/1980SCF       
AP07/14/1981SLR       
AP08/9/1983SLR       
AP07/29/1983SCP       
AP03/31/1983SLR       
AP012/11/1987SCM       
AP06/9/1986SLR       
AP07/23/1987SCM       
AP07/15/1987SCS       
AP03/29/1995SLR       
AP04/25/1994SCM       
AP01/22/1996SCS       
AP012/22/1997SCS       
AP04/2/1998SCP       
AP09/30/1998SCM       
AP011/24/1999SCS       
AP08/21/2001SCS       
AP01/18/2006SLR13425040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf 1/20/2006
AP01/18/2006SLR13464040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017604s040ltr.pdf 1/20/2006
AP08/7/2007SLR17615041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017604s041ltr.pdf 8/14/2007
AP08/7/2007SLR17623041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf 8/14/2007
AP07/21/2009SCF23028043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017604s043ltr.pdf 7/23/2009
AP07/21/2009SCF23064043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf 7/24/2009
AP05/9/2016SLR45928046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017604Orig1s046ltr.pdf 5/11/2016
AP05/9/2016SLR45986046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf 5/11/2016
AP010/7/2016SCM       




Back to FDA Applications sponsored by XSPIRE