Back to FDA Applications sponsored by ENDO VENTURES LTD

FDA Drug Application 022239 by ENDO VENTURES LTD

Application Number022239
Application Type New Drug Application
Sponsor ApplicantENDO VENTURES LTD
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
AP07/15/2009N23001000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022239s000ltr.pdf 7/20/2009
AP07/15/2009N23047000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf 7/23/2009
AP07/15/2009N25766000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239_sumavel_dosepro_toc.cfm 6/22/2010
AP07/15/2009N25767000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239s000Sumr.pdf 6/22/2010
AP06/27/2011SLR29297002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf 6/27/2011
AP06/27/2011SLR29380002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022239s002ltr.pdf 7/5/2011
AP06/2/2016SCM46260004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf 6/6/2016
AP011/26/2013SE837952005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022239Orig1s005ltr.pdf 11/27/2013
AP011/26/2013SE838010005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf 12/12/2013




Back to FDA Applications sponsored by ENDO VENTURES LTD