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FDA Drug Application 010151 by PARKE DAVIS

Application Number010151
Application Type New Drug Application
Sponsor ApplicantPARKE DAVIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/1/1956N       
AP01/9/1978SLR       
AP01/28/1977SCP       
AP011/30/1978SLR       
AP01/8/1979SCE       
AP06/3/1981SCM       
AP012/15/1981SLR       
AP06/2/1983SCM       
AP011/20/2001SPD1692022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SPD17098022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S022_DILANTIN_AP.pdf 7/6/2007
AP08/10/1983SCP       
AP05/20/1986SCP       
AP09/30/1986SCP       
AP09/30/1986SCP       
AP011/20/2001SLR1693029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR17093029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S029_DILANTIN_AP.pdf 7/6/2007
AP011/20/2001SLR1694030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR17092030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S030_DILANTIN_AP.pdf 7/6/2007
AP011/22/1995SLR       
AP011/20/2001SLR1695032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR17091032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S032_DILANTIN_AP.pdf 7/6/2007
AP011/20/2001SLR1696033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR17090033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S033_DILANTIN_AP.pdf 7/6/2007
AP011/20/2001SLR1697034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR17089034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S034_DILANTIN_AP.pdf 7/6/2007
AP05/30/1997SCF       
AP011/13/2011SLR30629036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010151s036lbl.pdf 11/16/2011
AP011/13/2011SLR30656036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010151s036ltr.pdf 11/21/2011
AP03/6/2013SLR35356037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010151Orig1s037ltr.pdf 3/8/2013
AP03/6/2013SLR35381037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010151s037lbl.pdf 3/8/2013
AP01/24/2014SLR38373038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s050,010151Orig1s038ltr.pdf 1/28/2014
AP01/24/2014SLR38386038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf 1/28/2014
AP04/3/2014SLR38975039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf 4/4/2014
AP04/3/2014SLR38981039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s051,010151Orig1s039ltr.pdf 4/4/2014
AP04/15/2015SLR42541040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf 4/16/2015
AP04/15/2015SLR42550040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008762Orig1s052,10151Orig1s040ltr.pdf 4/17/2015
AP01/25/2016SLR45017041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/08762Orig1s054,10151Orig1s041ltr.pdf 1/26/2016
AP01/25/2016SLR45020041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf 1/26/2016
AP06/16/2016SLR46379042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf 6/21/2016




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