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FDA Drug Application 019543 by MERCK SHARP DOHME

Application Number019543
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)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/1987N       
AP010/29/1987SCM       
AP010/3/1995SE5       
AP09/25/1991SCS       
AP04/16/1996SCS       
AP03/7/1997SCP       
AP06/9/1998SCM       
AP012/28/1998SCM       
AP011/10/1998SCP       
AP01/20/2000SCS       
AP07/17/2002SLR1767011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19543slr011,se5-013ltr.pdf 7/17/2002
AP07/17/2002SLR1768011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf 7/17/2002
AP02/27/2002SCS       
AP07/17/2002SE51769013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19543slr011,se5-013ltr.pdf 7/17/2002
AP07/17/2002SE51770013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543s11s13lbl.pdf 7/17/2002
AP012/15/2002SLR8943014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19543slr014ltr.pdf 6/3/2004
AP012/15/2002SLR1766014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19543slr014_Elocon_lbl.pdf 12/15/2002
AP03/28/2013SLR35580024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019543Orig1s024ltr.pdf 4/1/2013
AP03/28/2013SLR35616024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019543s024lbl.pdf 4/1/2013
AP08/5/2016SCM       




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