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FDA Drug Application 018998 by VALEANT PHARMS NORTH

Application Number018998
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS NORTH
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
AP012/24/1985N11451000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_Vasotec.cfm 4/27/2005
AP012/24/1985N14272000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP010/27/1986SCS       
AP011/7/1986SCS       
AP010/3/1986SLR       
AP05/14/1987SLR15269005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S005_Vasotec_APPROVAL PACKAGE.pdf 10/26/2006
AP01/28/1987SLR15270006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S006_Vasotec_APPROVAL PACKAGE.pdf 10/26/2006
AP06/24/1988SE1       
AP07/10/1987SCP15271009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S009_Vasotec_APPROVAL PACKAGE.pdf 10/26/2006
AP04/25/1988SLR18572011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S011_VASOTEC.pdf 11/19/2007
AP07/26/1988SCF       
AP08/3/1988SCM18571013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S013_VASOTEC.pdf 11/19/2007
AP03/29/1989SLR17063015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S015_ VASOTEC_AP.pdf 7/6/2007
AP01/10/1989SLR18570016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S016_VASOTEC.pdf 11/19/2007
AP02/20/1991SCM17881017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S017_VASOTEC.pdf 9/14/2007
AP04/18/1989SLR17062018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S018_VASOTEC_AP.pdf 7/6/2007
AP011/30/1989SLR17061020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S020_VASOTEC_AP.pdf 7/6/2007
AP03/9/1990SLR17317021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S021_VASOTEC.pdf 7/20/2007
AP06/12/1990SE117318022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S022_VASOTEC.pdf 7/20/2007
AP07/19/1990SCP17319023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S023_VASOTEC.pdf 7/20/2007
AP011/28/1990SLR17882024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S024_VASOTEC.pdf 9/14/2007
AP02/6/1991SLR17883025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S025_VASOTEC.pdf 9/14/2007
AP08/2/1991SCP       
AP04/8/1992SE5       
AP09/30/1992SCP       
AP05/13/1992SLR       
AP05/7/1992SLR       
AP011/4/1993SE1       
AP09/30/1992SLR       
AP07/31/1996SLR17020034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S034_VASOTEC_AP.pdf 7/6/2007
AP07/26/1993SCM       
AP02/24/1993SLR       
AP07/1/1993SLR       
AP05/11/1994SLR27423038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s038_vasotec.pdf 1/4/2011
AP01/14/1994SLR27424039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s039_vasotec.pdf 1/4/2011
AP010/21/1993SLR27425040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s040_vasotec.pdf 1/4/2011
AP012/12/1994SCM16756041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S041_VASOTEC_AP.pdf 6/12/2007
AP07/15/1994SCS16757042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S042_VASOTEC_AP.pdf 6/12/2007
AP02/18/1994SLR27840043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s043_vasotec.pdf 2/15/2011
AP05/16/1994SLR27841044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_s044_vasotec.pdf 2/15/2011
AP07/25/1994SLR16758045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S045_VASOTEC_AP.pdf 6/12/2007
AP09/28/1995SLR17019046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018998_S046_VASOTEC_AP.pdf 7/6/2007
AP09/19/1995SCS       
AP09/19/1995SCS       
AP09/19/1995SCS       
AP03/22/1996SCM17018050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018998_S050_VASOTEC_AP.pdf 7/6/2007
AP01/9/1997SCM16191051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018998_S051_VASOTEC_AP.pdf 4/9/2007
AP02/3/1997SCM16192052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/018998_S052_VASOTEC_AP.pdf 4/9/2007
AP06/11/1997SLR4351053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf 6/11/1997
AP07/23/1997SCP       
AP07/21/1997SCM       
AP012/10/1997SCS       
AP02/17/1999SLR3910057   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf 6/22/2001
AP011/27/2001SLR2255058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm 11/27/2001
AP011/27/2001SLR5192058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf 11/27/2001
AP011/27/2001SLR5193058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf 11/27/2001
AP02/13/2001SE82258059   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec.cfm 2/13/2001
AP02/13/2001SE85196059   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_Approv.pdf 2/13/2001
AP02/13/2001SE85197059   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S059_Vasotec_prntlbl.pdf 2/13/2001
AP02/4/2002SCM15221061   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S061_Vasotec_APPROVAL PACKAGE.pdf 10/25/2006
AP04/3/2002SCS15222062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S062_Vasotec_APPROVAL_PACKAGE.pdf 10/25/2006
AP08/30/2002SCM2257063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18998scm063ltr.pdf 8/30/2002
AP010/10/2002SCM15258064   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018998_S064_Vasotec_APPROVAL PACKAGE.pdf 10/26/2006
AP010/31/2007SLR18364070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018998s070, 019221s037ltr.pdf 11/8/2007
AP09/25/2008SLR20898071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018998s071, 019221s038ltr.pdf 9/29/2008
AP09/25/2008SLR25586071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018998s071lbl.pdf 5/18/2010
AP02/17/2012SLR31846076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s076lbl.pdf 2/22/2012
AP02/17/2012SLR31869076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998s076ltr.pdf 2/23/2012
AP09/13/2012SLR33754077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018998s077lbl.pdf 9/14/2012
AP09/13/2012SLR33764077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018998Origs077ltr.pdf 9/17/2012
AP012/24/2014SLR41441079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018998Orig1s079ltr.pdf 12/30/2014
AP012/24/2014SLR41603079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018998s079lbl.pdf 1/9/2015
AP08/25/2015SLR43719080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018998s080lbl.pdf 8/26/2015
AP08/25/2015SLR43726080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018998Orig1s080ltr.pdf 8/27/2015




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