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FDA Drug Application 050748 by KING PHARMS

Application Number050748
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
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
AP09/21/1999N252000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50747ltr.pdf 9/21/1999
AP09/21/1999N253000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50748lbl.pdf 9/21/1999
AP09/21/1999N3340000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50747_Synercid.cfm 7/18/2001
AP07/13/2000SLR       
AP08/24/2000SCS       
AP012/26/2002SCM       
AP012/26/2002SCS       
AP06/18/2008SLR20038008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf 6/19/2008
AP06/18/2008SLR20050008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050747s008,050748s008ltr.pdf 6/20/2008
AP011/12/2010SLR26967009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf 11/17/2010
AP011/12/2010SLR27000009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf 11/22/2010
AP011/12/2010SLR27001010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050747s011,050748s009,050748s010ltr.pdf 11/22/2010
AP011/12/2010SLR26968010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050747s011,050748s009s010lbl.pdf 11/17/2010
AP01/13/2012SLR31404013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050747s014,050748s013ltr.pdf 1/18/2012
AP01/13/2012SLR31521013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050747s014,050748s013lbl.pdf 1/25/2012




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