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FDA Drug Application 018827 by MERCK SHARP DOHME

Application Number018827
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP07/10/1984N       
AP02/22/1985SCP       
AP04/23/1986SCM       
AP05/20/1986SCS       
AP09/12/1986SCM       
AP010/29/1987SCM       
AP08/1/1990SCS       
AP010/3/2001SLR5255007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s7s9s20s22lbl.pdf 4/15/2003
AP09/11/1990SCS       
AP010/3/2001SLR       
AP010/6/1994SCP       
AP01/30/1995SCM       
AP01/30/1995SCS       
AP06/15/1998SCS       
AP07/31/1998SCS       
AP05/18/1998SCS       
AP011/10/1998SCP       
AP05/14/1999SCS       
AP02/2/2000SCS       
AP010/3/2001SLR       
AP02/28/2001SCS       
AP010/3/2001SE56278022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18827s22ltr.pdf 7/31/2003
AP010/3/2001SE512391022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18827s22lbl.pdf 7/29/2005
AP01/10/2002SCS       
AP03/27/2003SLR4646025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18827slr025_lotrisone_lbl.pdf 3/28/2003
AP03/27/2003SLR5275025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18827slr025ltr.pdf 4/15/2003
AP01/25/2008SLR18963038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018827s038ltr.pdf 1/29/2008
AP01/25/2008SLR18969038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018827s038lbl.pdf 1/30/2008
AP05/11/2009SLR22567042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018827s042ltr.pdf 5/13/2009
AP05/11/2009SLR22890042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018827s042lbl.pdf 7/8/2009
AP04/21/2014SLR39111046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018827Orig1s046ltr.pdf 4/22/2014
AP04/21/2014SLR39118046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018827s046lbl.pdf 4/22/2014




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