Back to FDA Applications sponsored by PURDUE PHARMA LP

FDA Drug Application 019516 by PURDUE PHARMA LP

Application Number019516
Application Type New Drug Application
Sponsor ApplicantPURDUE PHARMA LP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/29/1987N33135000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311374.pdf 7/11/2012
AP05/29/1987N33136000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP04/8/1988SCS       
AP09/12/1989SCS       
AP01/16/1990SCS       
AP011/8/1993SCS       
AP05/2/1988SCS       
AP04/12/1990SCF       
AP04/29/1997SCM       
AP05/12/2000SCS       
AP05/2/2000SCM       
AP05/2/2000SCM       
AP05/2/2000SCM       
AP05/2/2000SCM       
AP06/27/2000SCM       
AP05/2/2000SCM       
AP02/12/2001SLR       
AP012/18/2001SLR       
AP02/21/2003SCP9239019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516scp019ltr.pdf 6/9/2004
AP08/6/2003SLR6487021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516slr021ltr.pdf 8/14/2003
AP05/11/2007S16613030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019516s030ltr.pdf 5/29/2007
AP05/11/2010SLR25547034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019516s034ltr.pdf 5/14/2010
AP05/11/2010SLR25570034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf 5/17/2010
AP07/9/2012SLR33138036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s036ltr.pdf 7/11/2012
AP07/9/2012SLR33158036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf 7/12/2012
AP07/9/2012SLR33184037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf 7/13/2012
AP07/9/2012SLR33148037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s037ltr.pdf 7/11/2012
AP04/15/2013SLR35715038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019516Orig1s038ltr.pdf 4/16/2013
AP06/2/2014SCM       
AP04/16/2014SLR39069042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf 4/16/2014
AP04/16/2014SLR39078042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s042ltr.pdf 4/17/2014
AP010/22/2014SLR40897043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf 10/30/2014
AP010/22/2014SLR40901043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf 10/30/2014
AP08/19/2014S40279044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s044ltr.pdf 8/20/2014
AP06/26/2015S43134046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019516Orig1s046ltr.pdf 6/29/2015
AP04/20/2016S45715047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s047ltr.pdf 4/22/2016
AP09/21/2016SCM       
AP09/30/2016S47263050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s050ltr.pdf 10/4/2016




Back to FDA Applications sponsored by PURDUE PHARMA LP

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.