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FDA Drug Application 018024 by PAR PHARM INC

Application Number018024
Application Type New Drug Application
Sponsor ApplicantPAR PHARM INC
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
AP05/15/1979N       
AP06/28/1979SLR       
AP01/24/1980SCM       
AP02/21/1980SCM       
AP02/20/1981SCM       
AP04/1/1981SCM       
AP05/27/1982SCF       
AP05/27/1982SCE       
AP05/20/1982SCP       
AP05/20/1982SCM       
AP03/2/1984SCF       
AP03/2/1984SCE       
AP010/23/1986SE1       
AP02/16/1983SLR       
AP08/17/1983SCM       
AP08/17/1983SCM       
AP09/17/1984SCS       
AP09/13/1984SCM       
AP09/13/1984SCM       
AP011/28/1984SCF       
AP03/3/1988SCE       
AP08/4/1987SLR       
AP011/10/1988SLR       
AP012/7/1987SCS       
AP011/10/1988SCF       
AP010/19/1990SCM       
AP011/2/1994SLR       
AP010/15/1993SCS       
AP012/15/1995SCS       
AP04/30/2003SLR5749036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18024slr036ltr.pdf 5/30/2003
AP04/30/2003SLR17302036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018024_S036_NUBAIN_INJECTION.pdf 7/18/2007
AP04/16/2002SCM       
AP01/15/2002SCS       
AP010/25/2002SCS       
AP08/23/2005S17514040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018024_S040_NUBAIN.pdf 8/6/2007
AP08/23/2005S12677040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018024s040ltr.pdf 8/31/2005
AP08/23/2005S12686040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018024s040lbl.pdf 8/31/2005




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