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FDA Drug Application 012380 by PARKE DAVIS

Application Number012380
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
AP011/2/1960N26583000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM227571.pdf 9/30/2010
AP06/2/1980SCS       
AP012/11/1980SCM       
AP02/3/1981SCM       
AP05/28/1981SCF       
AP05/28/1981SCM       
AP012/9/1981SCM       
AP09/3/1982SCF       
AP011/8/1983SCP       
AP07/31/1984SCS       
AP01/8/1991SCM       
AP04/9/2001SLR21022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf 4/9/2001
AP04/9/2001SLR25023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf 4/9/2001
AP02/22/1996SCS       
AP04/9/2001SLR271025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12380S25ltr.pdf 4/9/2001
AP06/28/2000SCM       
AP09/22/2000SCM       
AP04/19/2002SLR2033029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12380s029.pdf 4/19/2002
AP09/1/2006SLR14859030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/012380s030ltr.pdf 9/18/2006
AP04/23/2009SLR22350031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/012380s031lbl.pdf 4/28/2009
AP04/23/2009SLR22355031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/012380s031ltr.pdf 4/29/2009
AP09/14/2010SLR26498032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012380s032ltr.pdf 9/20/2010
AP09/14/2010SLR26507032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012380s032lbl.pdf 9/20/2010
AP06/15/2011SLR29207033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012380s033ltr.pdf 6/17/2011
AP05/3/2012SLR32638034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034lbl.pdf 5/7/2012
AP05/3/2012SLR32639034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012380s034mg.pdf 5/7/2012
AP05/3/2012SLR32663034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012380s034ltr.pdf 5/9/2012
AP05/17/2016SLR46070036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012380Orig1s036ltr.pdf 5/20/2016
AP05/17/2016SLR46098036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012380s036lbl.pdf 5/20/2016




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