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FDA Drug Application 008762 by PARKE DAVIS

Application Number008762
Application Type New Drug Application
Sponsor ApplicantPARKE DAVIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/6/1953N31003000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM283845.pdf 12/16/2011
AP03/18/1975SCS       
AP02/23/1978SCP       
AP011/22/1978SLR       
AP08/16/1979SLR       
AP09/24/1979SCP       
AP012/8/1980SCM       
AP03/23/1990SLR       
AP03/23/1990SLR       
AP03/23/1990SLR       
AP011/20/2001SLR1688020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR1689021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP011/20/2001SLR1690022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP02/22/1996SCS       
AP07/10/1996SCS       
AP011/20/2001SLR1691026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/08762s20s21s22s26ltr.pdf 11/20/2001
AP010/15/1997SCS       
AP02/19/1998SCS       
AP02/24/1998SCS       
AP02/24/1998SCP       
AP03/24/2003SLR4509031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08762slr031ltr.pdf 3/26/2003
AP011/29/2011SLR30830032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf 12/1/2011
AP011/29/2011SLR30977032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf 12/14/2011
AP04/23/2009SLR22349036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008762s036lbl.pdf 4/28/2009
AP04/23/2009SLR22352036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/008762s036ltr.pdf 4/29/2009
AP01/17/2011SLR27582038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s038ltr.pdf 1/24/2011
AP01/17/2011SLR27590038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038lbl.pdf 1/25/2011
AP01/17/2011SLR27591038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s038MedG.pdf 1/25/2011
AP011/29/2011SLR30831039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf 12/1/2011
AP011/29/2011SLR30978039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf 12/14/2011
AP011/29/2011SLR33003039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/008762Orig1s039.pdf 6/26/2012
AP011/29/2011SLR30832040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf 12/1/2011
AP011/29/2011SLR30979040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf 12/14/2011
AP011/29/2011SLR30833041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf 12/1/2011
AP011/29/2011SLR30980041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf 12/14/2011
AP05/27/2011SLR28994042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s042ltr.pdf 5/31/2011
AP011/29/2011SLR30834043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/008762s032,s039,s040,s041ltr.pdf 12/1/2011
AP011/29/2011SLR30981043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008762s032s039s040s041s043lbl.pdf 12/14/2011
AP03/6/2013SLR35355047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008762Orig1s047ltr.pdf 3/8/2013
AP03/6/2013SLR35382047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008762s047lbl.pdf 3/8/2013
AP08/8/2013SCM       
AP09/6/2013SCM       
AP01/24/2014SLR38372050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s050,010151Orig1s038ltr.pdf 1/28/2014
AP01/24/2014SLR38387050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s050,010151s038lbl.pdf 1/28/2014
AP04/3/2014SLR38976051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/008762s051,010151s039lbl.pdf 4/4/2014
AP04/3/2014SLR38980051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/008762Orig1s051,010151Orig1s039ltr.pdf 4/4/2014
AP04/15/2015SLR42542052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008762s052,010151s040lbl.pdf 4/16/2015
AP04/15/2015SLR42549052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008762Orig1s052,10151Orig1s040ltr.pdf 4/17/2015
AP04/30/2015SCM       
AP01/25/2016SLR45018054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/08762Orig1s054,10151Orig1s041ltr.pdf 1/26/2016
AP01/25/2016SLR45019054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s054,010151s041lbl.pdf 1/26/2016
AP06/16/2016SLR46378055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008762s055,010151s042lbl.pdf 6/21/2016




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