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FDA Drug Application 021799 by SUN PHARM INDS

Application Number021799
Application Type New Drug Application
Sponsor ApplicantSUN PHARM INDS
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
AP08/12/2005N12604000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021799lbl.pdf 8/15/2005
AP08/12/2005N12615000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021799ltr.pdf 8/16/2005
AP08/12/2005N20181000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021799s000TOC.cfm 7/9/2008
AP08/12/2005N24182000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM192698.pdf 12/3/2009
AP010/3/2007SLR18119006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021799s006ltr.pdf 10/4/2007
AP010/3/2007SLR18230006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021799s006lbl.pdf 10/10/2007
AP011/14/2008SLR21234008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021799s008lbl.pdf 11/17/2008
AP011/14/2008SLR21243008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021799s008ltr.pdf 11/18/2008
AP06/15/2010SLR25754011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021799s011ltr.pdf 6/17/2010
AP06/15/2010SLR25784011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021799s011lbl.pdf 6/24/2010
AP012/23/2009SLR24387013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021799s013ltr.pdf 12/31/2009
AP011/20/2009SLR24613014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021799s014ltr.pdf 1/25/2010
AP011/20/2009SLR24088014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021799s014lbl.pdf 11/23/2009
AP01/22/2010SLR24680015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021799s015ltr.pdf 1/29/2010
AP04/14/2011SLR28560016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021799s016lbl.pdf 4/18/2011
AP04/14/2011SLR28577016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021799s016ltr.pdf 4/19/2011
AP05/22/2012S       
AP02/22/2013SLR35242021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021799Orig1s021ltr.pdf 2/26/2013
AP02/22/2013SLR35256021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s021lbl.pdf 2/26/2013
AP05/22/2012SLR32759022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021799s022ltr.pdf 5/24/2012
AP04/13/2013SLR35705023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021799Orig1s023ltr.pdf 4/16/2013
AP04/13/2013SLR35728023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021799s023lbl.pdf 4/16/2013
AP07/2/2014SLR39745024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021799Orig1s024ltr.pdf 7/3/2014
AP07/2/2014SLR39756024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021799s024lbl.pdf 7/3/2014




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