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FDA Drug Application 019888 by ALVOGEN MALTA

Application Number019888
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
AP07/20/1989N       
AP010/13/1989SCS       
AP09/20/1990SCF       
AP011/8/1990SLR       
AP012/21/1990SCM       
AP02/21/1991SLR       
AP04/8/1991SCS       
AP04/11/1991SLR       
AP012/11/1991SCM       
AP06/25/1992SLR       
AP011/18/1992SCM       
AP011/18/1993SE2       
AP03/31/1993SLR3790012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19888-S12_Zestril.pdf 9/18/2001
AP08/5/1994SLR       
AP09/23/1993SLR       
AP06/13/1995SLR       
AP012/9/1993SLR       
AP08/5/1994SLR       
AP08/5/1994SLR       
AP09/15/1994SLR       
AP06/13/1995SLR6459020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019888s020_zestoretic_toc.cfm 8/8/2003
AP03/31/1995SLR       
AP010/26/1995SCS       
AP07/11/1995SCM       
AP01/5/1996SLR       
AP012/14/1995SCM       
AP01/5/1996SLR       
AP010/11/1996SCP       
AP01/14/1997SCM       
AP05/8/1998SLR       
AP011/18/1999SCS       
AP07/27/2000SCM       
AP012/15/2000SCM       
AP012/19/2000SCM       
AP012/18/2001SLR       
AP04/17/2003SLR5698035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19888slr035ltr.pdf 5/29/2003
AP05/24/2005SLR11705040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019888s040ltr.pdf 5/25/2005
AP06/16/2006SLR14336041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019777s050, 019888s041LTR.pdf 6/20/2006
AP07/16/2007SLR17342043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s052, 019888s043ltr.pdf 7/24/2007
AP010/4/2007SLR18201044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019777s053, 019888s044ltr.pdf 10/10/2007
AP05/20/2009SLR22611045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s045lbl.pdf 5/25/2009
AP05/20/2009SLR22618045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019888s045ltr.pdf 5/26/2009
AP011/6/2009SLR24028047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019888s047lbl.pdf 11/19/2009
AP011/6/2009SLR24467047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019888s047ltr.pdf 1/7/2010
AP03/11/2011SLR28218049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s049lbl.pdf 3/11/2011
AP03/11/2011SLR28253049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf 3/16/2011
AP08/4/2011SLR29689050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s050ltr.pdf 8/5/2011
AP08/4/2011SLR29696050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019888s050lbl.pdf 8/5/2011
AP05/2/2012SLR32616051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888s051ltr.pdf 5/4/2012
AP05/2/2012SLR32640051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s051lbl.pdf 5/7/2012
AP03/29/2012SLR32309052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s052lbl.pdf 3/29/2012
AP03/29/2012SLR32318052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888s052ltr.pdf 4/2/2012
AP010/31/2012SLR34222053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s053lbl.pdf 11/2/2012
AP010/31/2012SLR34245053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888Orig1s053ltr.pdf 11/5/2012
AP08/13/2012SLR33468054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019888s054lbl.pdf 8/15/2012
AP08/13/2012SLR33486054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019888Orig1s054ltr.pdf 8/16/2012
AP011/5/2013SLR37735055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019888s055lbl.pdf 11/8/2013
AP011/5/2013SLR37745055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019888Orig1s055ltr.pdf 11/8/2013
AP012/24/2014SLR41442056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019888Orig1s056ltr.pdf 12/30/2014
AP012/24/2014SLR41597056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019888s056lbl.pdf 1/9/2015
AP08/25/2015SLR43718065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019888s065lbl.pdf 8/26/2015
AP08/25/2015SLR43732065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019888Orig1s065ltr.pdf 8/27/2015




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