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FDA Drug Application 021813 by MEDA PHARMS

Application Number021813
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/15/2006N22719000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813_elestrin_toc.cfm 6/9/2009
AP012/15/2006N22720000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813s000_SumR.pdf 6/9/2009
AP012/15/2006N15494000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021813lbl.pdf 12/26/2006
AP012/15/2006N15532000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021813s000ltr.pdf 12/28/2006
AP02/26/2008SCP19335001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021813s001ltr.pdf 2/29/2008
AP02/24/2012SLR31921003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021813s003lbl.pdf 2/28/2012
AP02/24/2012SLR31967003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021813s003ltr.pdf 2/29/2012
AP02/27/2014SCM38650004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf 3/4/2014




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