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FDA Drug Application 022432 by QUESTCOR PHARMA

Application Number022432
Application Type New Drug Application
Sponsor ApplicantQUESTCOR PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/15/2010N26695000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf 10/19/2010
AP010/15/2010N26706000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022432s000ltr.pdf 10/20/2010
AP010/15/2010N26844000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231714.pdf 11/1/2010
AP010/15/2010N26861000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM232049.pdf 11/3/2010
AP010/15/2010N29551000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432_hp_acthar_gel_toc.cfm 7/20/2011
AP010/15/2010N29552000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432Orig1s0900SumR.pdf 7/20/2011




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