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FDA Drug Application 019123 by UPSHER-SMITH LABS

Application Number019123
Application Type New Drug Application
Sponsor ApplicantUPSHER-SMITH LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/17/1986N25035000   http://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf 3/16/2010
AP04/17/1987SCF       
AP06/26/1987SCM       
AP08/25/1987SCP       
AP07/31/1987SCS       
AP06/2/1988SLR       
AP011/7/1988SCM       
AP06/26/1992SE4       
AP07/24/1989SCS       
AP09/18/1989SCS       
AP07/18/1990SCS       
AP09/21/1989SCS       
AP07/17/1990SCF       
AP010/31/1991SCS       
AP07/2/1993SCP       
AP012/16/1994SCM       
AP04/8/1994SCM       
AP07/18/1995SCS       
AP07/18/1996SCP       
AP011/21/2003SLR6952021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19123slr021ltr.pdf 11/25/2003
AP05/24/2004SLR8668022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19123slr022ltr.pdf 5/27/2004
AP04/13/2006SLR13951024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019123s024ltr.pdf 4/20/2006
AP011/29/2013SCM       
AP08/29/2016SCM       




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