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FDA Drug Application 019915 by BRISTOL MYERS SQUIBB

Application Number019915
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/16/1991N14274000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP06/27/1991SCS       
AP06/27/1991SCS       
AP09/9/1991SCM       
AP06/25/1992SLR       
AP09/22/1992SCF       
AP07/10/1992SCM       
AP010/7/1992SLR       
AP04/5/1993SCM       
AP05/2/1995SE1       
AP05/19/1994SLR       
AP06/14/1994SCM       
AP012/30/1994SCM       
AP03/28/1995SCM       
AP02/8/1995SCM       
AP012/30/1994SCM       
AP03/27/1995SCM       
AP07/24/1996SLR       
AP09/29/1995SCS       
AP03/20/1996SCM       
AP08/2/1996SCM       
AP01/8/1997SLR       
AP01/14/1997SCM       
AP02/21/1997SCM       
AP09/12/1997SCM       
AP010/1/1997SCM       
AP01/28/1998SCM       
AP08/11/1998SCM       
AP03/11/1999SCM       
AP05/21/1999SCS       
AP05/24/1999SCM       
AP011/16/1999SCM       
AP08/29/2002SLR3634032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19915slr032ltr.pdf 8/29/2002
AP08/29/2002SLR6116032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-915S032.pdf 7/8/2003
AP06/26/2000SCS       
AP09/21/2000SCS       
AP05/27/2003SE55805037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915se5-037ltr.pdf 6/8/2003
AP05/27/2003SE55878037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19915se5-037_monopril_lbl.pdf 6/8/2003
AP010/29/2003SLR6874038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19915slr038,20286slr006ltr.pdf 11/5/2003
AP02/9/2009SLR21832042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019915s042,020286s008ltr.pdf 2/13/2009




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