Back to FDA Applications sponsored by PARKE DAVIS

FDA Drug Application 011909 by PARKE DAVIS

Application Number011909
Application Type New Drug Application
Sponsor ApplicantPARKE DAVIS
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
AP06/9/1961N16517000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP06/9/1961N24024000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088660.pdf 11/19/2009
AP08/27/1986SCM       
AP03/8/1978SLR       
AP08/27/1986SCS       
AP011/3/1982SLR       
AP03/28/1985SLR       
AP07/14/1994SCF       
AP02/24/1998SCM       
AP02/25/1998SCE       
AP01/3/2002SLR       
AP09/2/2003SLR6597033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11909slr033ltr.pdf 9/9/2003
AP09/2/2003SLR6598033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/11909slr033_nardil_lbl.pdf 9/9/2003
AP02/18/2005SLR11164035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/11909s035ltr.pdf 2/23/2005
AP02/6/2007SCP15816036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011909s036ltr.pdf 2/12/2007
AP02/6/2007SCP15853036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s036lbl.pdf 2/21/2007
AP08/2/2007SLR17487038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011909s038lbl.pdf 8/3/2007
AP08/2/2007SLR17580038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/01190516s2316798s5417516s2320990s252719839s596364ltr.pdf 8/7/2007




Back to FDA Applications sponsored by PARKE DAVIS

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.