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FDA Drug Application 021591 by SUN PHARM INDS LTD

Application Number021591
Application Type New Drug Application
Sponsor ApplicantSUN PHARM INDS LTD
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
AP09/11/2003N6667000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21591ltr.pdf 9/25/2003
AP09/11/2003N6698000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21591_riomet_lbl.pdf 9/26/2003
AP09/11/2003N10948000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-591_Riomet.cfm 1/11/2005
AP06/2/2004SLR9085001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21591slr001ltr.pdf 6/7/2004
AP06/2/2004SLR9131001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21591slr001_riomet_lbl.pdf 6/7/2004
AP09/20/2005SLR12823003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021591s003lbl.pdf 9/30/2005
AP09/20/2005SLR12937003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021591s003ltr.pdf 10/20/2005
AP010/20/2008N21053004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021591s004ltr.pdf 10/23/2008
AP010/20/2008N21176004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021591s004lbl.pdf 11/7/2008
AP012/6/2010SLR27230005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021591s005lbl.pdf 12/6/2010
AP012/6/2010SLR27266005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021591s005ltr.pdf 12/10/2010
AP09/16/2013SCM       
AP08/29/2014SCM40400008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021591s008lbl.pdf 9/3/2014




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