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FDA Drug Application 020892 by ENDO PHARM

Application Number020892
Application Type New Drug Application
Sponsor ApplicantENDO PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/25/1998N505000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20892ltr.pdf 9/25/1998
AP09/25/1998N506000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892.cfm 9/25/1998
AP09/25/1998N507000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20892lbl.pdf 9/25/1998
AP08/5/1999SCE       
AP04/24/2001SCS       
AP011/2/2011SLR30497013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020892s013lbl.pdf 11/4/2011
AP011/2/2011SLR30528013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020892s013ltr.pdf 11/7/2011
AP012/20/2012SCM       
AP08/2/2013S36693016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020892Orig1s016ltr.pdf 8/5/2013
AP011/12/2013SCM       
AP01/17/2014SCM       
AP04/7/2016SLR45623019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020892s019lbl.pdf 4/8/2016
AP04/7/2016SLR45634019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020892Orig1s019ltr.pdf 4/11/2016




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