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FDA Drug Application 022203 by MEDA PHARMS

Application Number022203
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
AP010/15/2008N21047000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022203s000ltr.pdf 10/22/2008
AP010/15/2008N23179000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022203s000TOC.cfm 8/14/2009
AP010/15/2008N23180000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022203s000SUMR.cfm 8/14/2009
AP08/31/2009SLR23748003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s003lbl.pdf 11/6/2009
AP08/31/2009SLR24119003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022203s003ltr.pdf 11/24/2009
AP01/19/2011SLR27592006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022203s006lbl.pdf 1/25/2011
AP01/19/2011SLR27599006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022203s006ltr.pdf 1/25/2011
AP08/30/2013SE836946008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022203Orig1s008ltr.pdf 9/4/2013
AP08/30/2013SE837018008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022203s008lbl.pdf 9/9/2013
AP03/13/2014SCM       
AP02/20/2015SE841907010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf 2/24/2015
AP02/20/2015SE841890010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf 2/23/2015
AP02/20/2015SE841891011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf 2/23/2015
AP02/20/2015SE841908011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf 2/24/2015
AP09/25/2015SCM       




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