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FDA Drug Application 022351 by AR HOLDING CO INC

Application Number022351
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
AP07/30/2009N23099000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022351lbl.pdf 7/31/2009
AP07/30/2009N23119000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176363.pdf 8/4/2009
AP07/30/2009N23135000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022351s000ltr.pdf 8/6/2009
AP07/30/2009N24810000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351_colcrys_toc.cfm 2/17/2010
AP07/30/2009N24811000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022351s000_SumR.pdf 2/17/2010




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