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FDA Drug Application 021793 by MEDA PHARMS

Application Number021793
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/10/2005N11806000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021793ltr.pdf 6/14/2005
AP06/10/2005N11807000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021793lbl.pdf 6/14/2005
AP06/10/2005N17299000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021793s000TOC.cfm 7/18/2007
AP06/30/2009SLR22868004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf 7/6/2009
AP06/30/2009SLR23446004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf 9/22/2009
AP06/30/2009SLR27876004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021793_s004a_reglan tablets.pdf 2/15/2011
AP09/4/2009SLR23432005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052,021793s005medguide.pdf 9/21/2009
AP09/4/2009SLR23681005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf 10/26/2009
AP09/9/2010SLR26445007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s007lbl.pdf 9/10/2010
AP09/9/2010SLR26516007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021793s007ltr.pdf 9/21/2010
AP011/18/2010SLR27003008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf 11/22/2010
AP011/18/2010SLR27023008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf 11/26/2010
AP011/18/2010SLR27024008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008MedG.pdf 11/26/2010
AP08/2/2011SLR29681009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s009ltr.pdf 8/5/2011
AP011/30/2011SLR30794011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s011ltr.pdf 11/30/2011
AP011/30/2011SLR30866011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011lbl.pdf 12/2/2011
AP011/30/2011SLR30867011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011mg.pdf 12/2/2011




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