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FDA Drug Application 021451 by DENTSPLY PHARM

Application Number021451
Application Type New Drug Application
Sponsor ApplicantDENTSPLY PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/2003N7348000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21451ltr.pdf 12/23/2003
AP012/19/2003N7439000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21451_oraqix_lbl.pdf 12/29/2003
AP012/19/2003N14796000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021451s000_OraqixTOC.cfm 9/7/2006
AP04/13/2010SLR25289005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s005lbl.pdf 4/19/2010
AP04/13/2010SLR25307005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s005ltr.pdf 4/20/2010
AP09/27/2010SLR26554007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s007lbl.pdf 9/27/2010
AP09/27/2010SLR26557007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s007ltr.pdf 9/29/2010
AP08/8/2012SLR33419008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021451s008lbl.pdf 8/9/2012
AP08/8/2012SLR33421008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021451Orig1s008ltr.pdf 8/10/2012




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