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FDA Drug Application 010596 by PARKE DAVIS

Application Number010596
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/8/1957N26659000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229201.pdf 10/13/2010
AP05/23/1977SLR       
AP01/27/1981SCM       
AP01/27/1981SCF       
AP08/20/1987SCS       
AP04/9/2001SLR2373009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf 4/9/2001
AP01/24/1990SLR       
AP012/11/1995SCS       
AP04/9/2001SLR2374012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf 4/9/2001
AP010/20/1997SCP       
AP04/12/1999SCM       
AP04/11/2000SCM       
AP04/17/2002SLR2372017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10596s17ltr.pdf 4/17/2002
AP04/23/2009SLR22348021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf 4/28/2009
AP04/23/2009SLR22353021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010596s021ltr.pdf 4/29/2009
AP010/11/2010SLR26627022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf 10/11/2010
AP010/11/2010SLR26635022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s022medguide.pdf 10/12/2010
AP010/11/2010SLR26652022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010596s022ltr.pdf 10/13/2010
AP06/15/2011SLR29206023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010596s023ltr.pdf 6/17/2011




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