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FDA Drug Application 022246 by SALIX PHARMS

Application Number022246
Application Type New Drug Application
Sponsor ApplicantSALIX PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/4/2009N23282000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022246s000ltr .pdf 9/9/2009
AP09/4/2009N23408000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022246s000lbl.pdf 9/18/2009
AP09/4/2009N23633000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187064.pdf 10/19/2009
AP09/4/2009N25140000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022246_metozolv_odt_toc.cfm 3/30/2010
AP09/4/2009N25141000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022246s000_SumR.pdf 3/30/2010
AP011/18/2010SLR26988001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022246s001lbl.pdf 11/18/2010
AP011/18/2010SLR27006001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022246s001ltr.pdf 11/22/2010
AP08/22/2011S       
AP08/22/2011SLR29952005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022246s005ltr.pdf 9/6/2011
AP09/27/2011SLR30133006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022246s006ltr.pdf 9/29/2011
AP09/27/2011SLR30161006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022246s006lbl.pdf 9/30/2011




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