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FDA Drug Application 019778 by MERCK

Application Number019778
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/16/1989N       
AP08/9/1989SLR       
AP010/30/1989SCM       
AP04/12/1990SLR       
AP02/6/1991SLR       
AP03/28/1991SLR       
AP09/30/1992SCP       
AP01/23/1992SCP       
AP05/7/1992SLR       
AP05/13/1992SLR       
AP09/30/1992SLR       
AP09/3/1996SLR       
AP03/10/1993SLR       
AP011/18/1993SE2       
AP01/14/1994SLR       
AP05/11/1994SLR       
AP09/23/1993SLR       
AP03/10/1994SLR       
AP07/24/1994SLR       
AP05/30/1995SLR       
AP02/22/1995SLR       
AP03/21/1995SCS       
AP06/8/1995SCM       
AP09/28/1995SLR       
AP09/28/1995SLR       
AP011/1/1995SCS       
AP010/28/1998SLR652028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028.cfm 10/28/1998
AP010/28/1998SLR4997028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_appltrs.pdf 10/28/1998
AP010/28/1998SLR4998028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19778s028_Prinzide_prntlbl.pdf 10/28/1998
AP02/17/1999SLR3389029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf 6/22/2001
AP08/7/2001SLR       
AP06/9/2000SCM       
AP011/8/2002SLR3903032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778slr032ltr.pdf 11/8/2002
AP08/23/2001SCM       
AP07/2/2002SCM3902034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19778s034ltr.pdf 7/2/2002
AP07/2/2002SCM8395034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19778-S-034_Prinzide_review.pdf 4/21/2004
AP03/2/2004SLR7806035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19558slr044,19778slr035ltr.pdf 3/3/2004
AP010/5/2005SLR12864036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019778s036ltr.pdf 10/11/2005
AP06/16/2006SLR14338037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s047, 019778s037LTR.pdf 6/20/2006
AP010/18/2006SLR15184039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019558s049, 019778s039ltr.pdf 10/23/2006
AP02/2/2007SLR15800040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019558s050, 019778s040LTR.pdf 2/12/2007
AP010/9/2008SLR21015042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042, s043ltr.pdf 10/14/2008
AP010/9/2008SLR21016043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019778s042, s043ltr.pdf 10/14/2008
AP06/10/2011SLR29219044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP01/28/2011SLR27816045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s045lbl.pdf 2/11/2011
AP011/17/2011SLR30695046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s054,019778s046ltr.pdf 11/21/2011
AP011/17/2011SLR30721046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778Orig1s046_REPLACEMENT.pdf 11/21/2011
AP08/26/2011SLR29919047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019778s047lbl.pdf 8/30/2011
AP08/26/2011SLR29929047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019778s047ltr.pdf 8/31/2011
AP06/6/2012SLR32860048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019558Orig1s055,019778Orig1s048ltr.pdf 6/8/2012
AP06/6/2012SLR32876048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019778s048lbl.pdf 6/11/2012
AP02/26/2013SLR35275049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019778Orig1s049ltr.pdf 2/28/2013
AP02/26/2013SLR35318049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019778s049lbl.pdf 3/1/2013




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