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FDA Drug Application 019386 by BAXTER HLTHCARE

Application Number019386
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1986N10325000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-386_ Brevibloc.cfm 10/4/2004
AP08/15/1988SCP18623001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf 12/6/2007
AP08/15/1988SLR18624002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S001&S002_BREVIBLOC_INJ.pdf 12/6/2007
AP012/18/1992SE1       
AP08/15/1988SCS18625004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf 12/6/2007
AP05/26/1989SCM18627005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S005_BREVIBLOC.pdf 12/6/2007
AP08/15/1988SLR18626006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S004&S006_BREVIBLOC.pdf 12/6/2007
AP05/11/1989SLR18628007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S007_BREVIBLOC.pdf 12/6/2007
AP012/18/1992SE2       
AP010/21/1991SLR19156009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S009_BREVIBLOC_INJECTION.pdf 2/19/2008
AP07/1/1993SLR19157010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S010_BREVIBLOC_INJECTION.pdf 2/19/2008
AP011/24/1993SCS19158011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S011_BREVIBLOC.pdf 2/19/2008
AP01/13/1994SCS19159012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019386_S012_BREVIBLOC.pdf 2/19/2008
AP010/4/1995SLR       
AP02/23/2000SCM17884015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019386_S015_BREVIBLOC_INJECTION.pdf 9/14/2007
AP01/19/2000SLR       
AP01/26/2001SCS17885017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S017_BREVIBLOC_INJECTION.pdf 9/14/2007
AP02/16/2001SCP17886018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019386_S018_BREVIBLOC_INJECTION.pdf 9/14/2007
AP01/27/2003SCF4834019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf 1/27/2003
AP01/27/2003SCF4331020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf019,02ltr.pdf 1/27/2003
AP02/25/2003SCF4264021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf021ltr.pdf 3/10/2003
AP02/25/2003SCF6102021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-386s021.cfm 7/8/2003
AP05/28/2003SCM17132022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019386_S022_Brevibloc.pdf 7/6/2007
AP05/28/2003SCM5748022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scm022ltr.pdf 5/30/2003
AP08/18/2003SCF6538024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19386scf024ltr.pdf 8/26/2003
AP011/6/2007SLR18343039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019386s039lbl.pdf 11/7/2007
AP011/6/2007SLR18367039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019386s039ltr.pdf 11/8/2007
AP08/13/2013SCM       
AP012/11/2012SLR34620043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019386s043lbl.pdf 12/13/2012
AP012/11/2012SLR34655043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019386Orig1s043ltr.pdf 12/13/2012
AP03/20/2014SCM       
AP01/26/2015SCM       
AP08/14/2015SCM       




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