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FDA Drug Application 018045 by PHARMACIA AND UPJOHN

Application Number018045
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
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
AP012/24/1981N       
AP06/30/1982SCS       
AP04/25/1986SCS       
AP010/22/1984SLR       
AP08/17/1987SLR       
AP04/28/1993SCS       
AP03/16/1994SCP       
AP010/5/1995SCM       
AP02/18/1994SCM       
AP010/9/1998SLR       
AP01/25/1994SCS       
AP03/16/1995SCS       
AP01/11/1996SCS       
AP01/18/2002SLR1774016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18045s16ltr.pdf 1/18/2002
AP010/15/1998SCM       
AP02/10/1999SCM       
AP02/10/1999SCM       
AP09/7/2001SCS       
AP010/28/2003SLR6847021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18045slr021ltr.pdf 10/29/2003
AP010/28/2003SLR6858021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18045slr021_emcyt_lbl.pdf 10/31/2003
AP07/9/2008SLR20184023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018045s023lbl.pdf 7/10/2008
AP07/9/2008SLR20198023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018045s023ltr.pdf 7/14/2008
AP02/14/2013SCM       




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