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FDA Drug Application 017555 by MERCK SHARP DOHME

Application Number017555
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/2/1975N       
AP01/26/1978SCF       
AP01/25/1978SCP       
AP04/29/1977SLR       
AP03/24/1978SLR       
AP03/13/1980SCF       
AP07/13/1978SCS       
AP010/22/1979SCP       
AP03/12/1980SLR       
AP01/29/1980SCM       
AP01/29/1980SLR       
AP02/11/1980SCP       
AP01/12/1981SCF       
AP09/9/1980SLR       
AP09/2/1981SLR       
AP06/9/1983SCP       
AP08/21/1981SCF       
AP05/4/1983SCS       
AP01/17/1986SLR       
AP01/17/1986SLR       
AP01/17/1986SLR       
AP09/13/1984SCS       
AP05/11/1984SCS       
AP03/2/1984SCM       
AP05/6/1985SCM       
AP07/30/1985SLR       
AP07/12/1985SCP       
AP01/17/1986SLR       
AP01/17/1986SLR       
AP02/26/1988SCS       
AP04/21/1988SLR       
AP04/11/2001SLR4172036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP04/11/2001SLR4173037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP04/11/2001SLR4174038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP04/11/2001SLR4175039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP04/11/2001SLR4176040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP07/13/1995SCS       
AP05/16/1996SCP       
AP04/11/2001SLR4177045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP011/7/1997SCP       
AP012/4/1997SCF       
AP011/26/1997SCF       
AP04/11/2001SLR4178050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP04/11/2001SLR4179051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP04/4/2000SCM       
AP06/6/2000SCM       
AP04/11/2001SLR3245055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17555s36s37s38s39s40s45s50s51s55ltr.pdf 4/11/2001
AP07/17/2014SLR39915056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf 7/22/2014
AP07/17/2014SLR39925056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf 7/23/2014
AP03/16/2001SCM       
AP02/1/2001SCS       
AP02/1/2001SCS       
AP03/16/2001SCS       
AP010/11/2001SCM       
AP09/5/2002SCM       
AP07/17/2014SLR39926068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf 7/23/2014
AP07/17/2014SLR39916068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf 7/22/2014
AP012/31/2008SLR36190069   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/017555Orig1s069.pdf 6/3/2013
AP012/31/2008SLR21509069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017555s069ltr.pdf 1/6/2009
AP012/31/2008SLR21535069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017555s069lbl.pdf 1/6/2009
AP02/1/2011SCM27717070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017555s070lbl.pdf 2/4/2011
AP02/1/2011SCM27750070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017555s070,019856s027ltr.pdf 2/7/2011
AP07/17/2014SLR39917071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017555s056s068s071lbl.pdf 7/22/2014
AP07/17/2014SLR39927071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017555Orig1s068,s056,s071,019856Orig1s024,s016,s028ltr.pdf 7/23/2014




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