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FDA Drug Application 020547 by PAR PHARM INC

Application Number020547
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
AP09/26/1996N       
AP04/28/1997SLR       
AP07/10/1997SLR       
AP05/6/1998SCM       
AP01/23/1998SLR       
AP05/6/1998SCM       
AP08/17/1998SLR       
AP09/17/1999SE11040007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20547s07ltr.pdf 9/17/1999
AP09/17/1999SE18337007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-547-S007_Accolate.cfm 4/14/2004
AP03/17/1999SLR8574008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20547-s008_accolate.pdf 5/25/2004
AP04/30/1999SCM       
AP09/9/1999SCM       
AP02/7/2000SLR8573011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20547-S011_Accolate.pdf 5/25/2004
AP011/12/1999SCM       
AP06/12/2000SLR       
AP04/27/2001SE16197014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20547s014ltr.pdf 7/29/2003
AP09/19/2000SCM       
AP01/8/2001SCM       
AP010/31/2003SLR8572017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20547slr017ltr.pdf 5/25/2004
AP03/26/2004SLR8255019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20547slr019_accolate_lbl.pdf 4/5/2004
AP06/6/2005SLR11775022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020547s022ltr.pdf 6/8/2005
AP06/6/2005SLR11780022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020547s022lbl.pdf 6/8/2005
AP05/29/2008SLR19912025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020547s025ltr.pdf 6/2/2008
AP08/21/2009SLR23255027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020547s027lbl.pdf 8/28/2009
AP08/21/2009SLR23986027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020547s027ltr.pdf 11/19/2009
AP07/14/2010SLR25970029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s029ltr.pdf 7/15/2010
AP07/14/2010SLR25982029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s029lbl.pdf 7/19/2010
AP010/13/2010SLR26679030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020547s030ltr.pdf 10/19/2010
AP010/13/2010SLR26703030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020547s030lbl.pdf 10/19/2010
AP08/8/2011SLR29729031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf 8/8/2011
AP08/8/2011SLR29731031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020547s031ltr.pdf 8/10/2011
AP05/15/2013SCM       
AP011/15/2013SLR37836033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020547Orig1s033ltr.pdf 11/18/2013
AP011/15/2013SLR37894033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020547s033lbl.pdf 11/22/2013
AP03/29/2016SCM       




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