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FDA Drug Application 018226 by VALIDUS PHARMS INC

Application Number018226
Application Type New Drug Application
Sponsor ApplicantVALIDUS PHARMS INC
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
AP02/28/1983N       
AP011/22/1983SCS       
AP08/1/1984SES       
AP012/14/1984SCP       
AP07/3/1985SCM       
AP07/3/1985SCM       
AP08/8/1985SCM       
AP09/6/1985SLR       
AP01/5/1989SLR       
AP012/10/1987SCM       
AP012/10/1987SCS       
AP010/14/1988SCS       
AP03/1/1991SLR       
AP07/1/1992SCS       
AP06/11/1993SCS       
AP010/21/1993SLR       
AP02/10/1998SLR       
AP04/18/1997SCS       
AP03/4/1997SCS       
AP01/6/1999SCS       
AP02/24/1999SCM       
AP010/29/2002SLR4541024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf 10/29/2002
AP010/29/2002SLR3826024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf 10/29/2002
AP010/29/2002SLR4221024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm 3/7/2003
AP010/29/2002SLR4222025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm 3/7/2003
AP010/29/2002SLR3827025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf 10/29/2002
AP010/29/2002SLR4542025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf 10/29/2002




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