Back to FDA Applications sponsored by BARR

FDA Drug Application 074803 by BARR

Application Number074803
Application Type Abbreviated New Drug Application
Sponsor ApplicantBARR
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/2/2001N6317000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074803_fluoxetine_toc.cfm 8/4/2003
TA16/14/2000TA6317000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074803_fluoxetine_toc.cfm 8/4/2003
AP08/2/2001N9023000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74803ta.pdf 6/4/2004
TA16/14/2000TA9023000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74803ta.pdf 6/4/2004
AP08/2/2001N9024000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Approv.pdf 6/4/2004
TA16/14/2000TA9024000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Approv.pdf 6/4/2004
AP08/2/2001N9025000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf 6/4/2004
TA16/14/2000TA9025000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf 6/4/2004
AP08/2/2001N12436000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
TA16/14/2000TA12436000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
AP012/13/2001SCB       
AP012/13/2001SCR       
AP012/13/2001SCB       
AP01/30/2002SL5094004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf 4/9/2003
AP01/30/2002SCR5095005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf 4/9/2003
AP01/30/2002SCA5096006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf 4/9/2003
AP01/30/2002SCB5097007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf 4/9/2003
AP01/30/2002SCR5098008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf 4/9/2003
AP01/30/2002SCB5093009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf 4/9/2003
AP011/26/2002SCS       




Back to FDA Applications sponsored by BARR

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.