Back to FDA Applications sponsored by DELCOR ASSET

FDA Drug Application 022013 by DELCOR ASSET

Application Number022013
Application Type New Drug Application
Sponsor ApplicantDELCOR ASSET
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
AP01/12/2007N20930000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022013_oluxe_toc.cfm 10/3/2008
AP01/12/2007N15658000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022013lbl.pdf 1/16/2007
AP01/12/2007N15711000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022013s000ltr.pdf 1/25/2007
AP07/17/2007SCP17339001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022013s001ltr.pdf 7/24/2007
AP011/10/2010SLR26948005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022013s005lbl.pdf 11/12/2010
AP011/10/2010SLR26981005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022013s005ltr.pdf 11/18/2010
AP04/23/2013SLR35841009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022013Orig1s009ltr.pdf 4/24/2013
AP04/23/2013SLR35880009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022013s009lbl.pdf 4/30/2013
AP04/21/2016SCM       




Back to FDA Applications sponsored by DELCOR ASSET