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FDA Drug Application 021565 by ALLERGAN

Application Number021565
Application Type New Drug Application
Sponsor ApplicantALLERGAN
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
AP010/16/2003N6820000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21565ltr.pdf 10/14/2003
AP010/16/2003N6827000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf 10/17/2003
AP010/16/2003N7459000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-565_Elestat.cfm 12/31/2003
AP08/15/2005SCP12611005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf 8/16/2005
AP08/15/2005SCP12632005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021565s005ltr.pdf 8/19/2005
AP012/20/2011SLR31222006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021565s006ltr.pdf 12/22/2011
AP012/20/2011SLR31233006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf 12/23/2011
AP06/17/2013SCM       
AP02/25/2016SCM       




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