Back to FDA Applications sponsored by APGDI

FDA Drug Application 202611 by APGDI

Application Number202611
Application Type New Drug Application
Sponsor ApplicantAPGDI
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/28/2012N33052000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202611Orig1s000ltr.pdf 6/28/2012
AP06/28/2012N33053000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202611s000lbl.pdf 6/28/2012
AP06/28/2012N33424000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202611Orig1s000TOC.cfm 8/10/2012
AP03/4/2013SCM       
AP07/19/2013SCM       
AP03/13/2014SCM       
AP02/9/2015SCM       
AP011/2/2015SLR44368005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s005lbl.pdf 11/4/2015
AP011/2/2015SLR44385005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s005ltr.pdf 11/4/2015
AP08/10/2015SLR43619006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202611Orig1s006ltr.pdf 8/11/2015
AP08/10/2015SLR43628006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202611s006lbl.pdf 8/11/2015
AP08/16/2016SLR46794007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202611s007lbl.pdf 8/17/2016
AP08/16/2016SLR46797007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202611Orig1s007ltr.pdf 8/18/2016
AP08/1/2016SCM       




Back to FDA Applications sponsored by APGDI

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.