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FDA Drug Application 018225 by VALIDUS PHARMS INC

Application Number018225
Application Type New Drug Application
Sponsor ApplicantVALIDUS PHARMS INC
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
AP02/28/1983N       
AP011/29/1983SCS       
AP06/14/1985SES       
AP02/9/1984SCP       
AP012/18/1985SCS       
AP09/6/1985SLR       
AP01/5/1989SLR       
AP012/10/1987SCM       
AP08/28/1989SCP       
AP06/11/1991SCS       
AP03/1/1991SLR       
AP010/21/1993SLR       
AP08/12/1994SCP       
AP02/10/1998SLR       
AP08/20/1997SCP       
AP011/20/1997SCS       
AP01/6/1999SCS       
AP02/24/1999SCM       
AP010/29/2002SLR3824018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf 10/29/2002
AP010/29/2002SLR4219018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm 3/7/2003
AP010/29/2002SLR4539018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf 10/29/2002
AP010/29/2002SLR3825019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf 10/29/2002
AP010/29/2002SLR4220019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm 3/7/2003
AP010/29/2002SLR4540019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf 10/29/2002
AP011/9/2001SCP       
AP05/13/2003SLR5790022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18225slr022ltr.pdf 6/8/2003
AP01/21/2010SLR24594024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf 1/24/2010
AP01/21/2010SLR24640024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018225s024ltr.pdf 1/26/2010
AP09/28/2015SCM       




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