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FDA Drug Application 021076 by BAYER

Application Number021076
Application Type New Drug Application
Sponsor ApplicantBAYER
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
AP011/29/1999N3456000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve_prntlbl.pdf 11/29/1999
AP011/29/1999N8611000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve.cfm 5/26/2004
AP011/29/1999N12298000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 7/28/2005
AP011/29/1999N1121000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21076ltr.pdf 11/29/1999
AP05/15/2000SLR       
AP04/26/2000SCM       
AP02/15/2001SCS       
AP010/18/2001SCS       
AP012/21/2001SCS       
AP07/31/2002SLR3455007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21076slr007LTR.pdf 7/31/2002
AP01/6/2006SLR13435011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021076s011ltr.pdf 1/20/2006
AP08/4/2008SLR20510013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021076s013ltr.pdf 8/6/2008
AP04/17/2009SLR22301014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021076s014ltr.pdf 4/21/2009




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