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FDA Drug Application 021611 by ENDO PHARMS

Application Number021611
Application Type New Drug Application
Sponsor ApplicantENDO 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
AP06/22/2006N14361000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021611s000LTR.pdf 6/28/2006
AP06/22/2006N14388000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf 6/28/2006
AP06/22/2006N20954000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021610s000_021611s000TOC.cfm 10/3/2008
AP08/2/2006SLR14587001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf 8/4/2006
AP08/2/2006SLR14633001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf 8/7/2006
AP04/15/2010SLR25330004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021611s004ltr.pdf 4/22/2010
AP02/3/2011SLR27785005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021611s005lbl.pdf 2/9/2011
AP02/3/2011SLR27806005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021611s005ltr.pdf 2/10/2011
AP07/9/2012SLR33123007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021611Orig1s007ltr.pdf 7/11/2012
AP07/9/2012SLR39301007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf 5/14/2014
AP09/17/2013SCM       
AP08/11/2016SCM       




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