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FDA Drug Application 019558 by MERCK

Application Number019558
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1987N9341000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf 6/14/2004
AP012/29/1987N9342000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf 6/14/2004
AP012/29/1987N14276000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP010/25/1988SLR       
AP010/25/1988SLR       
AP08/19/1988SCS       
AP03/29/1989SLR       
AP01/31/1989SLR       
AP08/9/1989SLR       
AP06/14/1993SE1       
AP04/11/1990SLR       
AP01/7/1991SCS       
AP02/6/1991SLR       
AP03/28/1991SLR       
AP09/9/1991SCS       
AP09/30/1992SCP       
AP01/23/1992SCP       
AP05/7/1992SLR       
AP05/13/1992SLR       
AP09/30/1992SLR       
AP09/3/1996SLR       
AP03/10/1993SLR       
AP01/14/1994SLR       
AP05/11/1994SLR       
AP01/28/1994SCF       
AP09/23/1993SLR       
AP03/10/1994SLR       
AP07/24/1994SLR       
AP011/24/1995SE1       
AP02/22/1995SLR       
AP03/21/1995SCS       
AP06/8/1995SCM       
AP09/28/1995SLR       
AP06/26/1995SCS       
AP09/28/1995SLR       
AP011/1/1995SCS       
AP09/3/1996SLR       
AP02/17/1999SLR3390036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf 6/22/2001
AP03/15/1999SCM       
AP08/7/2001SLR       
AP06/9/2000SCM       
AP05/5/2004SLR8551040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr040ltr.pdf 5/7/2004
AP04/26/2001SCM       
AP08/23/2001SCM       
AP05/29/2003SE55797043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19558se5-043ltr.pdf 6/8/2003
AP05/29/2003SE55872043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19558se5-043_prinivil_lbl.pdf 6/8/2003
AP05/29/2003SE511432043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/19-558S043_Prinivil.cfm 4/17/2005
AP03/2/2004SLR7805044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf 3/3/2004
AP010/5/2005SLR12866046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019558s046ltr.pdf 10/11/2005
AP06/16/2006SLR14337047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf 6/20/2006
AP010/18/2006SLR15185049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf 10/23/2006
AP02/2/2007SLR15801050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf 2/12/2007
AP010/9/2008SLR21013051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf 10/14/2008
AP010/9/2008SLR21014052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019558s051, s052ltr.pdf 10/14/2008
AP06/10/2011SLR29210053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP011/17/2011SLR30694054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf 11/21/2011
AP011/17/2011SLR30720054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019558Orig1s054Lbl_REPLACEMENTS.pdf 11/21/2011
AP06/6/2012SLR32859055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf 6/8/2012
AP06/6/2012SLR32877055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019558s055lbl.pdf 6/11/2012
AP02/26/2013SLR35272056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019558Orig1s056ltr.pdf 2/28/2013
AP02/26/2013SLR35319056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019558s056lbl.pdf 3/1/2013
AP07/8/2015SLR43324057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s057ltr.pdf 7/13/2015
AP07/8/2015SLR43335057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s057lbl.pdf 7/13/2015
AP08/22/2014SCM       
AP08/28/2015SLR43772059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019558Orig1s059ltr.pdf 9/1/2015
AP08/28/2015SLR43785059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019558s059lbl.pdf 9/3/2015
AP010/14/2016SLR47382060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019558s060lbl.pdf 10/17/2016
AP010/14/2016SLR47385060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019558Orig1s060ltr.pdf 10/19/2016




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