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FDA Drug Application 050747 by KING PHARMS

Application Number050747
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
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
AP09/21/1999N250000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf 9/21/1999
AP09/21/1999N251000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50747lbl.pdf 9/21/1999
AP08/24/2000SCS       
AP03/13/2002SLR       
AP012/26/2002SCM       
AP012/26/2002SCS       
AP06/18/2008SLR20037008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf 6/19/2008
AP06/18/2008SLR20049008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008ltr.pdf 6/20/2008
AP011/12/2010SLR26969011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf 11/17/2010
AP011/12/2010SLR26999011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf 11/22/2010
AP01/13/2012SLR31403014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013ltr.pdf 1/18/2012
AP01/13/2012SLR31520014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050747s014,050748s013lbl.pdf 1/25/2012




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