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FDA Drug Application 011961 by VALIDUS PHARMS INC

Application Number011961
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
AP07/1/1959N16516000   http://www.fda.gov/cder/drug/antidepressants/default.htm 5/9/2007
AP07/1/1959N24012000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088633.pdf 11/19/2009
AP08/18/1998SE11017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11961ltr.pdf 8/18/1998
AP08/18/1998SE12017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/11961-s017.cfm 12/14/1998
AP08/18/1998SE13017   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/11961lbl.pdf 8/18/1998
AP08/19/1998SCS       
AP06/16/1993SCM       
AP06/23/2000SLR       
AP010/25/2001SCE       
AP01/12/2005SLR10961035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11961s035ltr.pdf 1/13/2005
AP01/12/2005SLR10985035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/11961s035lbl.pdf 1/13/2005
AP08/10/2007SLR17608039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011961s039ltr.pdf 8/14/2007
AP08/10/2007SLR17620039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011961s039lbl.pdf 8/14/2007




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