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FDA Drug Application 018738 by RANBAXY

Application Number018738
Application Type New Drug Application
Sponsor ApplicantRANBAXY
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
AP08/30/1985N       
AP012/18/1986SCM       
AP08/20/1990SLR       
AP07/20/1990SCS       
AP02/14/1991SCP       
AP03/8/1991SCS       
AP09/22/1993SCS       
AP05/30/2003SLR5794007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18738slr007ltr.pdf 6/8/2003
AP05/30/2003SLR5870007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf 6/8/2003
AP010/19/2001SCM       
AP07/8/2009SCP22932009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf 7/9/2009
AP07/8/2009SCP22946009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018738s009ltr.pdf 7/13/2009
AP05/19/2014SCM       




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