Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

FDA Drug Application 018891 by BOEHRINGER INGELHEIM

Application Number018891
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP010/10/1984N       
AP04/18/1985SLR       
AP09/18/1985SLR       
AP05/11/1988SLR       
AP05/11/1988SLR       
AP010/14/1987SCS       
AP07/21/1988SCS       
AP010/27/1988SCS       
AP012/7/1988SLR       
AP04/18/1989SLR       
AP06/9/1995SCM       
AP012/13/1989SCM       
AP08/17/1992SCM       
AP011/24/1992SCM       
AP02/19/1993SCM       
AP09/6/1996SLR6353015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.cfm 8/5/2003
AP09/6/1996SLR       
AP07/23/1996SCS       
AP07/23/1996SCS       
AP010/3/1997SCM       
AP09/22/1998SCS       
AP08/30/1999SCS       
AP08/13/2004SLR10060022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18891s022ltr.pdf 8/25/2004
AP04/13/2006SLR13935024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018891s024ltr.pdf 4/14/2006
AP011/13/2009SLR23877025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018891s025lbl.pdf 11/13/2009
AP011/13/2009SLR24458025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018891s025ltr.pdf 1/7/2010
AP04/28/2010SLR25440027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018891s027ltr.pdf 5/3/2010
AP04/28/2010SLR25500027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018891s027lbl.pdf 5/7/2010
AP05/31/2012SLR32818028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018891s028lbl.pdf 6/6/2012
AP05/31/2012SLR32840028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018891s028ltr.pdf 6/7/2012




Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

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.