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FDA Drug Application 017588 by CORDEN PHARMA

Application Number017588
Application Type New Drug Application
Sponsor ApplicantCORDEN PHARMA
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
AP08/4/1976N       
AP04/22/1977SCS       
AP011/14/1978SLR       
AP09/19/1980SCF       
AP08/7/1980SCE       
AP011/12/1980SLR       
AP011/12/1980SCP       
AP02/16/1982SLR       
AP010/14/1986SPD       
AP07/22/1983SLR       
AP06/28/1983SLR       
AP03/6/1985SCS       
AP06/18/1985SCM       
AP09/22/1986SLR       
AP09/22/1986SLR       
AP09/12/1986SCM       
AP09/12/1986SCM       
AP08/26/1987SCM       
AP07/5/1988SCS       
AP03/14/1991SCS       
AP011/14/1988SCM       
AP08/1/1990SCS       
AP03/2/1993SCS       
AP012/20/2002SLR3445031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17588slr031ltr.pdf 12/20/2002
AP06/1/1999SCM       
AP02/27/2003SLR4262033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17588slr033ltr.pdf 3/10/2003
AP04/30/2009SLR22440034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017588s034ltr.pdf 5/6/2009
AP04/30/2009SLR22486034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017588s034lbl.pdf 5/11/2009
AP011/21/2012SLR34451036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017588Orig1s036ltr.pdf 11/23/2012
AP011/21/2012SLR34492036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017588s036lbl.pdf 11/28/2012
AP05/12/2011SLR28807037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017588s037ltr.pdf 5/16/2011
AP05/12/2011SLR28829037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017588s037lbl.pdf 5/16/2011
AP08/14/2013SCM       
AP08/15/2013SLR36858039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017588s039lbl.pdf 8/21/2013
AP05/20/2014SLR39337040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017588Orig1s040ltr.pdf 5/22/2014
AP05/20/2014SLR39394040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017588s040lbl.pdf 5/28/2014
AP01/5/2015SCM       
AP01/6/2016SLR44940042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s042ltr.pdf 1/7/2016
AP01/6/2016SLR44942042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s042lbl.pdf 1/7/2016
AP01/29/2016SLR45059043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017588Orig1s043ltr.pdf 2/1/2016
AP01/29/2016SLR45085043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017588s043lbl.pdf 2/2/2016




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