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FDA Drug Application 019309 by BIOVAIL LABS INTL

Application Number019309
Application Type New Drug Application
Sponsor ApplicantBIOVAIL LABS INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/9/1988N14273000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP01/10/1989SLR       
AP04/18/1989SLR       
AP010/19/1989SLR       
AP011/30/1989SLR27858005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_s005_vasotec IV injection.pdf 2/15/2011
AP03/9/1990SLR       
AP01/29/1992SLR       
AP02/6/1991SLR27859008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_s008_vasotec iv injection.pdf 2/15/2011
AP05/7/1992SLR       
AP05/13/1992SLR       
AP09/30/1992SLR17362011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S011_VASOTEC I.V.INJECTION.pdf 7/24/2007
AP07/31/1996SLR17211012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019309_S012_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf 7/9/2007
AP02/24/1993SLR17363013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S013_VASOTEC I.V. INJECTION.pdf 7/24/2007
AP01/14/1994SLR15272014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S014_Vasotec I.V. Injection_Approval Package.pdf 10/26/2006
AP05/11/1994SLR15273015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S015_Vasotec I.V. Injection_Approval Package.pdf 10/26/2006
AP010/21/1993SLR17364016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S016_VASOTEC I.V. INJECTION.pdf 7/24/2007
AP02/18/1994SLR15274017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S014_Vasotec I.V. Injection_Approval Package.pdf 10/26/2006
AP07/25/1994SLR17210018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S018_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf 7/9/2007
AP09/28/1995SLR17209019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019309_S019_Vasotec I.V. Injection_APPROVAL PACKAGE.pdf 7/9/2007
AP010/27/1997SLR       
AP06/11/1997SLR4350021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019309_s021ap.pdf 6/11/1997
AP02/17/1999SLR3908022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf 6/22/2001
AP011/27/2001SLR9610023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_Approv.pdf 6/29/2004
AP011/27/2001SLR9611023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998S058_Vasotec_prntlbl.pdf 6/29/2004
AP011/27/2001SLR2244023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18-998s058_Vasotec.cfm 11/27/2001
AP012/6/2000SCS       
AP011/1/2002SLR2239025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19221slr027,19309slr025ltr.pdf 10/30/2002
AP012/17/2001SCS       
AP011/25/2002SCM       




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