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FDA Drug Application 017531 by KING PHARMS

Application Number017531
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/12/1974N       
AP05/23/1975SCS       
AP09/15/1981SLR       
AP012/13/2001SE23972010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17531S010ltr.pdf 4/30/2002
AP012/13/2001SE23973010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17531S010lbl.pdf 4/30/2002
AP012/13/2001SE217117010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017531_S010_TIGAN_CAPSULE_AP.pdf 7/6/2007
AP03/24/2008SLR19529012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017531s012ltr.pdf 3/26/2008
AP03/24/2008SLR19544012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s012lbl.pdf 3/27/2008
AP012/2/2008SLR21334013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017531s013lbl.pdf 12/8/2008
AP012/2/2008SLR21335013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017531s013ltr.pdf 12/10/2008




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