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FDA Drug Application 017892 by PHARMACIA AND UPJOHN

Application Number017892
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/15/1982N16049000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP011/15/1982N23997000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088610.pdf 11/19/2009
AP04/26/1985SCF       
AP010/23/1987SLR       
AP04/26/1985SLR       
AP012/6/1985SCM       
AP010/23/1987SLR       
AP010/23/1987SLR       
AP08/24/1988SCS       
AP010/23/1987SLR       
AP010/23/1987SLR       
AP03/25/1988SCP       
AP07/26/1988SCM       
AP05/5/1988SLR       
AP05/6/1988SLR       
AP03/20/1989SLR       
AP08/16/1990SLR       
AP08/16/1990SLR       
AP08/16/1990SLR       
AP05/21/1993SCS       
AP01/17/1991SLR       
AP011/13/1991SLR       
AP02/21/1992SCP       
AP05/25/1993SCS       
AP09/14/1993SLR       
AP07/13/1994SCM       
AP011/4/1994SCS       
AP04/4/1996SLR       
AP06/25/2003SLR6036034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17892slr034ltr.pdf 7/6/2003
AP06/25/2003SLR14067034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017892_s034_HalcionTOC.cfm 5/8/2006
AP011/4/1999SCP       
AP02/12/2008SLR19094038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017892s038ltr.pdf 2/14/2008
AP02/12/2008SLR19104038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017892s038lbl.pdf 2/14/2008
AP01/25/2013SCM       
AP01/21/2014SCM       
AP09/18/2014SLR40531047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017892s047lbl.pdf 9/22/2014
AP09/18/2014SLR40558047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017892Orig1s047ltr.pdf 9/23/2014
AP012/15/2015SCM       




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