Back to FDA Applications sponsored by RECKITT BENCKISER

FDA Drug Application 018658 by RECKITT BENCKISER

Application Number018658
Application Type New Drug Application
Sponsor ApplicantRECKITT BENCKISER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/8/1982N       
AP06/11/1984SLR       
AP05/10/1985SCS       
AP06/11/1984SLR       
AP06/12/1985SCS       
AP010/9/1986SCE       
AP08/10/1993SCS       
AP010/26/1993SCP       
AP010/26/1993SLR       
AP012/28/1992SCS       
AP011/8/1999SCM       
AP08/9/1999SCS       
AP02/15/2001SLR       
AP01/24/2002SLR1654015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18658S15LTR.PDF 1/24/2002
AP07/10/2002SCS       
AP011/10/2004SCF10593017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18658s017ltr.pdf 11/16/2004
AP011/10/2004SCF16190017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018658_S017_DELSYM_AP.pdf 4/9/2007
AP03/8/2005SCP11226018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18658s018ltr.pdf 3/10/2005
AP09/28/2007SCF18134022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018658s022ltr.pdf 10/4/2007
AP09/28/2007SCF18167022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018658s022lbl.pdf 10/4/2007
AP012/5/2008SLR21336023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018658s023ltr.pdf 12/10/2008
AP010/8/2009SLR23846026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018658s026ltr.pdf 11/12/2009
AP04/8/2010SLR25255027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018658s027ltr.pdf 4/13/2010
AP011/10/2010SCM26951028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018658s028ltr.pdf 11/15/2010
AP05/16/2011SLR28857029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018658s029ltr.pdf 5/19/2011
AP06/19/2014SLR39598030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018658Orig1s030ltr.pdf 8/11/2014
AP06/19/2014SLR40135030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018658Orig1s030lbl_replacement.pdf 8/5/2014




Back to FDA Applications sponsored by RECKITT BENCKISER

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.