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FDA Drug Application 019777 by ALVOGEN MALTA

Application Number019777
Application Type New Drug Application
Sponsor ApplicantALVOGEN MALTA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/19/1988N14275000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP06/30/1988SLR3784001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S1_Zestril.pdf 9/18/2001
AP09/20/1988SCP6391002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S2_ZestrilTablets_toc.cfm 8/5/2003
AP01/18/1989SCS3785003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S3_Zestril.pdf 9/18/2001
AP04/11/1989SLR3786004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S4_Zestril.pdf 9/18/2001
AP07/20/1989SLR       
AP09/5/1989SCS6392006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S6_ZestrilTablets_toc.cfm 8/5/2003
AP06/9/1993SE1       
AP011/8/1990SCS6393008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S8_ZestrilTablets_toc.cfm 8/5/2003
AP010/17/1990SLR3788009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19777-S9_Zestril.pdf 9/18/2001
AP04/11/1991SLR       
AP07/29/1991SCS6394011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S11_ZestrilTablets_toc.cfm 8/5/2003
AP012/11/1991SCM6395012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S12_Zestril_toc.cfm 8/5/2003
AP02/12/1992SCS6396013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S13_ZestrilTablets_toc.cfm 8/5/2003
AP06/25/1992SLR       
AP011/18/1992SCM6397015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S15_ZestrilTablets_toc.cfm 8/5/2003
AP04/29/1993SCF       
AP05/26/1993SCM6398017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S17_ZestrilTablets_toc.cfm 8/5/2003
AP03/31/1993SLR3789018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19888-S12_Zestril.pdf 9/18/2001
AP09/23/1993SLR       
AP06/13/1995SLR       
AP08/5/1994SLR       
AP05/17/1994SCM       
AP011/24/1995SE1       
AP06/5/1995SCM6399024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S24_ZestrilTablets_toc.cfm 8/5/2003
AP03/31/1995SLR       
AP07/11/1995SCS6400026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S26_ZestrilTablets_toc.cfm 8/5/2003
AP07/11/1995SCP6464027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S27_ZestrilTablets_toc.cfm 8/8/2003
AP010/26/1995SCM       
AP011/15/1995SLR6465030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S30_ZestrilTablets_toc.cfm 8/8/2003
AP010/11/1996SCP6466031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019777-S31_ZestrilTablets_toc.cfm 8/8/2003
AP01/8/1997SLR4298032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019777ap.pdf 1/8/1997
AP05/1/1998SLR2050033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19777-s033_zestril.pdf 5/1/1998
AP011/6/1998SCM2051034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19777-s034_zestril.pdf 11/6/1998
AP01/20/1999SCM2052035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19777-s035_Zestril.pdf 1/20/1999
AP02/24/1999SCM       
AP02/7/2000SE113287037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19777s037.pdf 12/16/2005
AP02/7/2000SE11213037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19777S37LTR.PDF 2/7/2000
AP011/18/1999SCS       
AP07/27/2000SCM       
AP012/19/2000SCM       
AP012/15/2000SCM       
AP07/1/2003N10147042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-777S042S044_Zestril.cfm 9/8/2004
AP07/1/2003N6044042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-044,slr042ltr.pdf 7/6/2003
AP07/1/2003N6088042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf 7/8/2003
AP03/30/2004SLR8311043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19777slr043ltr.pdf 4/7/2004
AP07/1/2003SE510148044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-777S042S044_Zestril.cfm 9/8/2004
AP07/1/2003SE56043044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19777se5-044,slr042ltr.pdf 7/6/2003
AP07/1/2003SE57461044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19777se5-044,slr042_zestril_lbl.pdf 1/2/2004
AP05/24/2005SLR11704049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019777s049ltr.pdf 5/25/2005
AP06/16/2006SLR14335050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050, 019888s041LTR.pdf 6/20/2006
AP07/16/2007SLR17343052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052, 019888s043ltr.pdf 7/24/2007
AP010/4/2007SLR18200053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053, 019888s044ltr.pdf 10/10/2007
AP05/20/2009SLR22612054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s054lbl.pdf 5/25/2009
AP05/20/2009SLR22627054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s054ltr.pdf 5/26/2009
AP011/6/2009SLR24027056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019777s056lbl.pdf 11/19/2009
AP011/6/2009SLR24463056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019777s056ltr.pdf 1/7/2010
AP06/26/2014SLR39670057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s057ltr.pdf 6/27/2014
AP06/26/2014SLR39691057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s057lbl.pdf 6/30/2014
AP08/4/2011SLR29724058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019777s058ltr.pdf 8/9/2011
AP08/4/2011SLR29768058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019777s058lbl.pdf 8/12/2011
AP05/2/2012SLR32615059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s059ltr.pdf 5/4/2012
AP05/2/2012SLR32623059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s059lbl.pdf 5/7/2012
AP03/29/2012SLR32310060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s060lbl.pdf 3/29/2012
AP03/29/2012SLR32317060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777s060ltr.pdf 4/2/2012
AP010/31/2012SLR34220061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s061lbl.pdf 11/2/2012
AP010/31/2012SLR34243061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s061ltr.pdf 11/5/2012
AP08/13/2012SLR33467062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019777s062lbl.pdf 8/15/2012
AP08/13/2012SLR33487062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019777Orig1s062ltr.pdf 8/16/2012
AP011/5/2013SLR37727063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019777Orig1s063ltr.pdf 11/7/2013
AP011/5/2013SLR37877063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019777s063lbl.pdf 11/21/2013
AP012/24/2014SLR41444064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019777Orig1s064ltr.pdf 12/30/2014
AP012/24/2014SLR41602064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019777s064lbl.pdf 1/9/2015
AP08/25/2015SLR43717073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019777s073lbl.pdf 8/26/2015
AP08/25/2015SLR43731073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019777Orig1s073ltr.pdf 8/27/2015
AP04/21/2016SLR45730074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019777Orig1s074ltr.pdf 4/22/2016
AP04/21/2016SLR45798074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019777s074lbl.pdf 4/29/2016




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