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FDA Drug Application 021406 by UPSHER SMITH

Application Number021406
Application Type New Drug Application
Sponsor ApplicantUPSHER SMITH
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
AP08/12/2005N16458000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021406s000TOC.cfm 5/9/2007
AP08/12/2005N12607000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021406lbl.pdf 8/15/2005
AP08/12/2005N12630000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021406ltr.pdf 8/19/2005
AP04/27/2006SLR14007003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021406s003lbl.pdf 5/1/2006
AP04/27/2006SLR14029003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021406s003LTR.pdf 5/1/2006
AP02/2/2007SLR15804007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021406s007ltr.pdf 2/12/2007
AP06/22/2009SLR22817008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021406s008lbl.pdf 6/24/2009
AP06/22/2009SLR22830008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021406s008ltr.pdf 6/26/2009
AP08/12/2011SLR29805016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021406s016lbl.pdf 8/16/2011
AP08/12/2011SLR29809016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021406s016ltr.pdf 8/17/2011
AP07/9/2014SLR39829017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021406Orig1s017,s022ltr.pdf 7/10/2014
AP07/9/2014SLR39830022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021406Orig1s017,s022ltr.pdf 7/10/2014
AP07/9/2014SLR39834022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021406s017s022lbl.pdf 7/11/2014
AP07/24/2014SCM       
AP09/16/2014SCM       




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