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FDA Drug Application 019555 by MERCK SHARP DOHME

Application Number019555
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/27/1987N       
AP010/29/1987SCM       
AP011/8/1988SLR       
AP05/24/1989SLR       
AP08/1/1990SCS       
AP06/29/1990SCS       
AP010/3/2001SLR1711008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf 10/3/2001
AP010/3/2001SLR1712008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf 10/3/2001
AP010/3/2001SLR1713008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm 10/3/2001
AP011/30/1995SCS       
AP06/15/1998SCS       
AP07/31/1998SCS       
AP012/7/1998SCS       
AP011/10/1998SCP       
AP05/14/1999SCS       
AP08/14/2000SCP       
AP010/3/2001SE51714016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19555s8ltr.pdf 10/3/2001
AP010/3/2001SE51715016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19555s8lbl.pdf 10/3/2001
AP010/3/2001SE51716016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-555S008_Diprosone.cfm 10/3/2001
AP04/4/2001SCS       
AP08/28/2006SE514771026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019555s026lbl.pdf 8/28/2006
AP08/28/2006SE514874026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019555s026ltr.pdf 9/18/2006
AP08/13/2014SLR40238033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf 8/14/2014
AP08/13/2014SLR40254033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019555s033lbl.pdf 8/15/2014




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