Back to FDA Applications sponsored by FOREST LABS

FDA Drug Application 021378 by FOREST LABS

Application Number021378
Application Type New Drug Application
Sponsor ApplicantFOREST LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/26/2004N10651000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021378ltr.pdf 12/2/2004
AP011/26/2004N10697000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021378lbl.pdf 12/2/2004
AP011/26/2004N13187000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021378s000_CombunoxTOC.cfm 11/30/2005
AP011/26/2004N23916000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088574.pdf 11/16/2009
AP03/2/2006SLR13741002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021378s002lbl.pdf 3/10/2006
AP03/2/2006SLR13825002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021378s002ltr.pdf 3/23/2006
AP06/20/2007SLR16841005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021378s005lbl.pdf 6/27/2007
AP06/20/2007SLR16900005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021378s005ltr.pdf 7/5/2007
AP09/2/2010SLR26410006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021378s006lbl.pdf 9/7/2010




Back to FDA Applications sponsored by FOREST LABS