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FDA Drug Application 022353 by AR HOLDING CO INC

Application Number022353
Application Type New Drug Application
Sponsor ApplicantAR HOLDING CO INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2009N23655000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022353lbl.pdf 10/21/2009
AP010/16/2009N23682000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022353s000ltr.pdf 10/26/2009
AP010/16/2009N23706000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf 10/30/2009
AP010/16/2009N24115000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm174382.htm 11/24/2009
AP010/16/2009N24815000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353_colcrys_toc.cfm 2/18/2010
AP010/16/2009N24816000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022353s000_SumR.pdf 2/18/2010




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